Whether it is hardware or software as a service – subscription services are rising to prominence in our daily lives. However, mention our subscription plan for regulatory affairs, and some might be left scratching their heads. While this is an understandable reaction to a layman, our subscription plan can aid businesses in need of regulatory assistance. 

In particular, medical companies may find our plan indispensable, given the nature of the industry, where regulations, standards, and best practices continuously evolve, thus necessitating constant vigilance and resources to maintain compliance. For those unaware of its benefits, let us delve into why businesses in the medical industry can benefit from our subscription plan.

Benefit #1: Stay Up-To-Date With The Latest Regulatory Changes

Staying abreast of the various regulatory and guideline changes and updates can be akin to navigating a complex maze, especially if the business operates in a new territory where the best practices differ significantly from its country of origin. Its unfamiliarity with local regulatory guidelines may cause it to work with outdated, incorrect information.

Our subscription plan allows companies to tap on our local expertise as a regulatory service provider to advise on regulatory issues revolving around their business plans and products. Our consultants regularly keep up-to-date on the latest regulatory changes and can provide real-time updates and insights into evolving guidelines pertinent to the industry. This helps businesses to come up with proactive compliance strategies and mitigate the risk of non-compliance penalties and reputational damage.

Benefit #2: Oversee Regulatory Affairs

Effective regulatory compliance requires robust oversight and management. So, beyond staying informed on the newest changes, it is essential for businesses to maintain comprehensive and precise oversight of their regulatory affairs. However, this can be challenging for those unfamiliar with local regulations and guidelines.

As part of the services offered by our subscription plan, our consultants can help manage various aspects of the enterprise’s regulatory affairs. This includes updating operational standard operating procedures (SOPs), conducting training for distributors based on materials prepared by the client, and attending meetings as the company’s regulatory affairs representative. That, in turn, empowers businesses to oversee their regulatory affairs with precision and confidence.

Benefit #3: Comprehensive Compliance Support

With our regulatory affairs subscription plan, businesses can access our comprehensive tools and resources tailored to streamline compliance processes. We can help expedite compliance tasks, fostering operational efficiency and risk mitigation, ensuring companies encounter minimal issues when expanding into a new market.

Benefit #4: Cost-Effective

Our regulatory affairs subscription plan offers a scalable and economical means of achieving compliance excellence, with comprehensive regulatory information and resources readily available. As a result, businesses can eliminate the need for costly in-house expertise and infrastructure.

Instead, by leveraging our local expertise to perform the work on their behalf, enterprises can eliminate the worry of rising costs while redirecting available resources to focus on more crucial objectives, such as growing and expanding the company.

Regulatory affairs management extends beyond product registration and securing the necessary approvals for marketing and distribution. Our subscription plan can help streamline the entire process, providing comprehensive support even after the initial registration stage and allowing businesses to maintain sustainable growth and ethical conduct in today’s regulatory environment. Contact us today if you are interested in learning more about our subscription plan.

Traditional Chinese Medicine (TCM) requires strict regulatory adherence in Singapore, with the practice heavily regulated by the Traditional Chinese Medicine Practitioners Board (TCMPB) under the Ministry of Health (MOH). To practise TCM legally in Singapore, practitioners must be registered with the TCMPB and hold a valid practising certificate.

The stringent scrutiny in terms of licensing, premise requirements, and adherence to good clinical practices also extends to all TCM clinics and healthcare establishments, with the MOH conducting regular inspections and audits to ensure every premise complies with these strict regulations. 

In addition, Chinese Proprietary Medicines (CPM) – i.e. medicinal products used according to the traditional Chinese medicine (TCM) system of treatment that are manufactured into finished dosage forms (for example, tablets, capsules, pills) – are governed by The Health Sciences Authority (HSA) and must comply with a set of safety and quality criteria before they are made available to the public in Singapore.

So, as you can see, those wishing to practise TCM or enter the CPM industry must navigate a complex tapestry of requirements to ensure everything is above board and their business complies with regulations set out by Singapore’s health authorities. Therefore, it is unsurprising that many turn to a regulatory affairs service for help. If you are in a similar boat, let us help you better understand the situation by sharing a regulatory overview of TCM in Singapore.

Read More: Navigating Regulatory Changes in Singapore’s Healthcare Industry

How is Traditional Chinese Medicine regulated in Singapore?

Presently, TCM clinics need not register with MOH. However, they are still subjected to scrutiny by MOH to ensure they comply with good clinical practices. Meanwhile, any professional who wishes to practise TCM in Singapore must be registered with the TCMPB and hold a valid practising certificate issued by the Board, which regulates the professional conduct and ethics of registered TCM practitioners.

If you wish to start a TCM practice and want to learn more about the comprehensive regulations, we recommend consulting a regulatory service provider to ensure full compliance.

How is Chinese Proprietary Medicines regulated in Singapore?

To ensure the safety and quality of CPM in Singapore, all local CPM dealers, including importers, manufacturers, re-packers, and wholesalers, must be licensed by HSA. These businesses must also apply for product listing approval for each CPM before importing, manufacturing, or selling the item in Singapore.

Needless to say, the process to get the products successfully listed with HSA is stringent, as dealers must meet relevant safety and quality requirements for their CPM. 

The products must not contain:

• Any potent/toxic substances controlled under the Poisons Act
• Any artificial chemical compounds found in Western medicines
• Excessive levels of toxic heavy metals like arsenic, lead, and mercury and microbial contamination

 

Additionally, all CPM products must have English labels with the following:

• Product Name
• Batch Number
• Expiry Date
• Active ingredients
• Dosage

 

Dealers are also not allowed to make claims for treating a specified list of severe medication conditions, such as diabetes and cancer, on their product labels. If the business is made aware of an adverse event, it must report the incident to HSA immediately.

After the CPM product is made available to the public, there is a post-market surveillance programme implemented to observe the safety of the medicines. 

Monitoring Process

• Firstly, a risk-based market surveillance programme is conducted to sample and test products found in the market. 
• Secondly, an adverse reaction surveillance programme draws on HSA’s network of local healthcare professionals and international regulatory partners to identify any medicines that may potentially cause adverse reactions. 

 

This system of checks and controls ensures that HSA is able to initiate timely recalls of harmful or defective products.

If you wish to learn how you can successfully navigate the complex regulatory requirements in the CPM industry, we recommend seeking the advice of an expert regulatory affairs management team.

The TCM regulatory landscape in Singapore underscores the nation’s commitment to professionalism, integrity, and patient safety. Every aspect, from practitioner qualifications to product quality control, is meticulously controlled to uphold standards of excellence and ethical conduct.

However, navigating this labyrinthine landscape need not be complex and confusing when you work with the correct regulatory affairs service. As a regulatory service provider with a wealth of experience assisting local and global pharmaceutical and medical companies, we are well-placed to answer any regulatory query you have about the industry. Contact us to schedule an appointment with our regulatory affairs management team today!

Regulatory compliance in the healthcare industry is essential to maintaining quality standards and preventing fraud and abuse, thus ensuring patient safety. However, local and overseas pharmaceutical and medical companies seeking to register their medical products in Singapore may find navigating the numerous regulations governing their operations overwhelming and time-consuming.

Due to the dynamic nature of the healthcare industry, staying abreast of regulatory changes is not just a best practice; it is a fundamental necessity. To help healthcare organisations adapt swiftly to new requirements and maintain compliance, let us explore the strategies for effectively navigating the various health product regulations in Singapore’s healthcare industry.

1. Stay informed through official sources

The cornerstone of regulatory compliance lies in staying informed. However, with widespread misinformation and speculations prevalent on the internet, it can be challenging to pinpoint the authenticity of a source. So, the best way to stay up-to-date on the latest and most accurate changes to existing health product regulations is to monitor official regulatory channels like the Health Science Authority (HSA). 

As the relevant regulatory authority on the healthcare industry in Singapore, HSA’s platform is the most trusted source for comprehensive and authoritative information on the latest healthcare regulations. Whenever there is an update, arrange a training session to ensure the medical staff is educated on the newest updates and is aware of the importance of adhering to them.

2. Leverage industry associations and professional networks

Besides turning to HSA as a trusted source of information, medical companies can leverage professional associations and networks in the healthcare industry to stay abreast of the latest regulatory changes. Due to their relevant ties to the industry, these platforms often provide valuable updates, insights, and guidance from industry experts.

Businesses can attend conferences, seminars, and workshops to network and stay connected with like-minded peers and experts. Engaging with and building partnerships with others in the industry can facilitate knowledge sharing, providing valuable insights into best practices and proactive approaches to navigating health product regulation changes.

3. Develop robust internal processes

Effectively navigating regulatory changes requires more than awareness; it demands dynamic internal processes that promptly react to new requirements. That is why every healthcare organisation should implement a comprehensive compliance programme tailored to their specific needs if they have not done so already.

This programme should include robust protocols for monitoring and addressing essential regulatory requirements, with a dedicated regulatory affairs management team responsible for oversight, providing regular staff training on compliance matters, and establishing mechanisms for reporting potential violations.

4. Regularly assess compliance and identify gaps

Regulatory compliance is an ongoing process necessitating regular self-assessment. By conducting regular internal audits of operations and documentation, healthcare organisations can identify and proactively address potential gaps before they manifest into significant problems. Such actions not only ensure long-term compliance. They also enhance the business’s ability to address shortcomings in processes and procedures.

5. Consult legal and regulatory experts

Healthcare organisations unsure of the best way to ensure their products comply with existing health product regulations should seek expert advice. A regulatory consulting service specialising in the healthcare industry will possess in-depth knowledge of the nuances of Singapore’s healthcare guidelines and can provide tailored guidance to navigate complex changes while ensuring compliance, thus minimising the risk of legal issues and penalties.

Learn More: The Role of Regulatory Affairs Management in International Expansion for Pharma Companies

The ability to navigate regulatory changes seamlessly is crucial to success in the dynamic realm of the healthcare industry. By taking a proactive approach to regulatory navigation, healthcare organisations can navigate complexities with confidence, uphold their stellar reputation, and contribute to the ongoing enhancement of healthcare standards in Singapore.

Remember, the healthcare landscape in Singapore may evolve. However, your commitment to compliance should remain steadfast. At The Reg Consultants, our regulatory affairs management team can help you stay informed and compliant, ensuring you can continue providing excellent patient care. Contact us today to learn how we can work with you to support your operation’s needs.

Fueled by a consumer base eager to try out new, up-and-coming products from around the world, Singapore’s cosmetics and personal care industry has experienced remarkable growth in recent years. However, this surge has also caused the demand for quality to rise, with more customers expecting better efficacy and product safety. This increases the challenge that companies in the cosmetics and personal care sector face with regulatory compliance. In this article, we’ll talk about the regulatory challenges that companies should pay attention to and the steps that need to be taken to ensure product safety, compliance, and sustainable growth. 

Learn More: 3 Facts to Know When Importing Cosmetics Into Singapore

1. Product Safety Assessment

The Health Sciences Authority (HSA) has made it mandatory for manufacturers to conduct rigorous safety assessments, such as toxicological evaluations, to identify any potential risks that their products could cause. This is because, all products, whether for medical applications or personal care, must be safe for use and must not cause any adverse reactions that could pose an issue for public health. 

2. Ingredient Restrictions

Apart from product safety assessments, HSA has also established strict regulations regarding the use of specific ingredients in cosmetic and personal care products to further ensure safety. 

Businesses must review and update their product formulations regularly to remove restricted ingredients or limit their use in order to comply with these regulatory standards. Additionally, they should invest in research and development to identify safer alternatives, and collaborate with suppliers who provide compliant raw materials. 

3. Product Labelling and Packaging

All product labels are required to display essential information about the product to provide customers with accurate information about what they are purchasing and for regulatory authorities to trace products in case of issues. They should include the manufacturer’s contact details, product name, a detailed ingredient list, warnings, and clear usage instructions.

To meet these requirements, businesses must work with designers and regulatory experts to craft labels that adhere to the guidelines, as well as conduct regular reviews of packaging and labelling to ensure they remain compliant with changing regulations. 

When it comes to complying with product labelling guidelines, there are numerous intricate details that require attention. We recommend working with a regulatory consulting service to ensure that you do not miss out on any key information.

4. Substantiating Claims

Any product claims, such as “anti-ageing” or “skin whitening,” must be substantiated by scientific evidence. HSA closely monitors these claims, and businesses advertising any misleading or unsupported claims can face penalties. 

If companies wish to include any of these claims in their product information or advertisement, research findings and data from scientific studies and clinical trials must be provided to validate these claims. Businesses can also work with qualified dermatologists or experts in related fields to conduct independent assessments of product efficacy. 

Otherwise, one simple way to ensure compliance is to avoid the mention of these terms. 

5. Good Manufacturing Practices (GMP)

Lastly, companies are required to follow a set of good manufacturing practices in order to better guarantee product quality and safety. They include, but are not limited to:

• Maintaining cutting-edge facilities designed to prevent contamination and ensure cleanliness
• Maintaining comprehensive records of manufacturing processes, testing, and quality control procedures
• Proper storage and distribution practices
• Providing adequate training and education to employees.

Regulatory affairs management in Singapore’s cosmetics and personal care industry is difficult to navigate but an important step to go through. By addressing the above-mentioned challenges effectively, companies can not only ensure compliance with local regulations but also enhance their reputation and competitiveness in the market.

The Reg Consultants is a regulatory service provider that offers both local and overseas cosmetics and personal care companies regulatory assistance. Contact us today to find out how we can help you. 

In the highly regulated pharmaceutical industry, ensuring compliance with guidelines imposed by regulatory authorities is an important step towards achieving business success. Not only does it ensure patient safety, it also affects the business’s reputation and market access opportunities.

Learn More: The Importance of Regulatory Affairs Management in the Healthcare Industry

In order to navigate the ever-evolving landscape of regulatory requirements, organisations can tap on the invaluable expertise of a regulatory service provider. In this article, we’ll explore the key advantages of engaging a regulatory consulting service in the pharma industry and how they can be beneficial to your business.

1. Regulatory Expertise
Working through the intricate maze of regulations set forth by governing bodies such as the Health Sciences Authority can be an overwhelming endeavour. The process involves complying with specific guidelines and submitting documents to obtain approvals, licenses, and certifications for the company’s products.

Regulatory service providers bring a wealth of knowledge and experience to the table, helping your organisation stay abreast of the latest industry developments and ensure compliance with the ever-changing regulatory landscape by handling these complex procedures for you.

2. Time and Cost Efficiency
The timeline of obtaining approvals for pharmaceutical products can be lengthy and resource-demanding. But with a regulatory consulting service, companies can streamline and expedite these processes to save substantial time and cost.

Regulatory service providers are well-versed in the documentation and submission procedures, ensuring that all necessary forms, reports, and data are prepared accurately and in compliance with regulatory standards. This greatly reduces the risk of incurring extra costs caused by delays, mistakes, or rejections as regulatory experts can proactively anticipate and address potential challenges and roadblocks to quicken up the process.

3. Global Market Access
Expanding into international markets is a strategic move for pharmaceutical companies seeking growth and global reach. However, that is when regulatory affairs can become even more complex than ever before.

In order to ensure compliance and obtain the necessary approvals to enter new markets, businesses will need to prepare and submit regulatory dossiers, addressing country-specific requirements. Regulatory service providers can help to streamline the market access process, reducing the time and effort required to bring pharmaceutical products to global markets.

Maintaining compliance with Singapore’s regulatory requirements can also be a stepping stone for many pharmaceutical companies. Singapore is recognised as a major pharmaceutical hub in Asia, boasting a robust regulatory framework and a well-established healthcare system. This reputation of stringent regulatory standards can enhance your business’s credibility and standing in the global pharma marketplace.

Furthermore, Singapore’s regulatory requirements often align with international guidelines and standards. This means that obtaining regulatory approval in other countries can be made easie

4. Risk Mitigation
Failing to comply with regulatory guidelines can result in severe consequences, including product recalls, legal liabilities, financial losses, damage to reputation, and even the suspension of operations. Regulatory service providers will conduct comprehensive risk assessments and audits, examining various aspects such as manufacturing processes, quality control procedures, labelling and packaging requirements, and clinical trial protocols to prevent these issues.

Through their meticulous scrutiny, they can help identify potential compliance issues, deviations, or vulnerabilities, and offer strategic guidance on how to rectify them. This will eventually translate to smoother approval processes and minimise the risk of problems arising after products are launched into the market.

5. Focus on Core Competencies
Handling regulatory affairs can often divert valuable internal resources from the company’s core competencies. With the assistance of a regulatory consulting service, your business can offload the burden and redirect your focus to important operations. Companies can optimise resource allocation and concentrate on driving innovation and growth while the experts help to obtain approvals and certifications swiftly.

The advantages of working with a regulatory service provider are far-reaching and invaluable. The expertise and guidance they offer will help your business ensure compliance and obtain the necessary approvals.

The Reg Consultants is a regulatory service provider offering regulatory consulting services for pharma companies. Contact us today to find out more about our solutions.

Due to the nature of the healthcare and pharmaceutical industry, products and services produced for medical use need to undergo strict processes and meet certain requirements before they are allowed on the market.

As the industry continues to grow and evolve, ensuring safety, efficacy, and quality through regulatory affairs management becomes even more crucial in order to safeguard public health. Read on to learn more about the importance of regulatory affairs management in the healthcare and pharmaceutical industry.

What is Regulatory Affairs Management?

Regulatory affairs management refers to the strategic and operational activities that involve ensuring that products and services comply with regulations, laws, and guidelines governing the pharmaceutical industry. Companies need to go through strategising work, submit regulatory documents, conduct risk assessments, and post-market surveillance to produce safe and effective products. This is crucial not only for the health and safety of the public, but also for companies to be able to market and sell their items in Singapore.

Why is Regulatory Affairs Management Important?

1. Patient Safety
Public health and safety is every country’s top priority when allowing the sale and purchase of medical or pharmaceutical products, and regulatory affairs management plays a crucial role in ensuring compliance with health products regulations and industry standards. The teams work closely with quality assurance departments to establish robust quality management systems that help in maintaining adherence to guidelines across the development, manufacturing, labelling, and distribution of healthcare products, including pharmaceuticals, medical devices, biologics, and diagnostics.

Learn More: How to Set Up a Quality Management System for a Small Company

They also help to identify and mitigate associated risks, establish protocols for quality control and assurance, and monitoring and auditing procedures to ensure that products consistently meet required standards. 

2. Market Access
Market access refers to the ability of a pharmaceutical product to enter and maintain a presence in the market, ensuring that others can access and benefit from them. Regulatory affairs management navigates the complex landscape of regulatory work, and is the key process to get through in order for companies to launch their products in Singapore. 

Applications for marketing authorisation and product registrations are prepared and submitted by regulatory affairs professionals. These documents will need to contain comprehensive and detailed information about the products, including data from preclinical and clinical studies, manufacturing processes, labelling information, and other relevant documentation. Businesses need to meet the necessary criteria and get their submitted applications approved in order to gain successful market entry.

3. Global Expansion
As companies look to expand their operations across international borders, they face a multitude of diverse regulatory requirements imposed by different countries and regions. This is when regulatory professionals come in to help companies navigate these complexities and ensure compliance with local regulations.

They assess the impact of regulatory requirements on the company’s products and develop strategies to streamline the regulatory processes, as well as determine the most efficient and cost-effective approach to meet the requirements of each target market.

Failure to meet regulatory guidelines in a specific market can lead to delays, financial losses, damaged reputation, and even the inability to enter that market altogether. They also establish productive relationships with each country’s regulatory authorities, facilitate communication, and address any regulatory concerns or queries that may arise. By effectively managing these interactions, regulatory affairs professionals contribute to smoother regulatory processes and faster market entries.

Regulatory affairs management is essential for a pharmaceutical company’s success locally and globally. It helps to ensure compliance, which is the most important requirement that any pharmaceutical business must meet.

However, regulatory compliance can be challenging.

The Reg Consultants is a regulatory service provider in Singapore that offers both local and overseas pharmaceutical and medical companies regulatory assistance. Contact us today to find out how we can help you. 

Navigating the complex landscape of regulations and compliance is a key concern for businesses operating in any industry. But it is extremely important in the pharmaceutical industry as the medical devices, therapeutic products, and services used can have detrimental effects on human health.

In Singapore, the role of regulatory affairs takes centre stage in ensuring adherence to stringent guidelines and facilitating smooth market access in the healthcare industry. But what exactly does it entail and what should medical and pharmaceutical businesses know about it? Find out more.

What is Regulatory Affairs?

Regulatory affairs refers to the field of activities and processes that deal with making sure businesses and products across various industries meet the necessary compliance and regulatory standards set by government agencies in Singapore. In the medical and pharmaceutical industry, regulatory affairs management refer to the development, registration, and marketing of pharmaceuticals, medical devices, biologics, and other healthcare products while ensuring their safety, efficacy, and quality. This plays a crucial role in safeguarding public health, consumer protection, and maintaining industry standards.

Key Aspects of Regulatory Affairs

1. Regulatory Strategy
Regulatory affairs management requires strategising work to make sure that pharmaceutical companies are able to meet regulatory requirements. It involves understanding the guidelines to comply with, the actionables, and formulating a plan to ensure compliance. Businesses have to assess the product’s intended use, identify potential regulatory hurdles, and devise strategies to address them effectively.

2. Regulatory Submissions
In order for businesses to market and sell their pharmaceutical products in Singapore, they’ll need to submit a series of documents to register these products and seek approval for marketing authorisation from the Health Sciences Authority (HSA). Regulatory submissions involve preparing and submitting these documentation and ensuring that the items adhere to health product regulations in Singapore. The submissions should include detailed information, such as the product’s composition, manufacturing process, preclinical and clinical data, and labelling information.

3. Compliance and Quality Assurance

One of the key considerations in regulatory affairs management is the safety and quality of medical and pharmaceutical products in Singapore. Compliance with regulatory requirements is of utmost importance, and businesses are required to monitor regulatory updates, conduct internal audits, implement corrective and preventive actions, and address any compliance gaps identified to provide safe products.

Learn More: 7 Steps To Solve Regulatory Issues

4. Risk Assessment
Another critical aspect of regulatory affairs is risk assessment, which is crucial to minimise potential patient harm and ensure product safety. It involves conducting risk assessments, such as hazard analysis, and devising risk mitigation strategies throughout the product lifecycle—development, manufacturing, and post-market stages.

5. Post-Market Surveillance
Post-market surveillance involves monitoring the safety and  quality of therapeutic products after they have been approved and made available on the market. These surveillance systems can include processes for adverse event reporting, complaint handling,being responsive to safety signals and reviewing risk management plans (RMP) . They ensure that any potential safety concerns or issues are promptly addressed through appropriate actions, such as product recalls or labelling updates.

6. Regulatory Intelligence
Keeping up-to-date with regulatory developments is crucial in regulatory affairs. Changes in regulations, policies, and guidelines issued by government agencies such as HSA, must be monitored, and actions must be taken to ensure compliance to these new updates.

Regulatory affairs is indispensable in the healthcare and pharmaceutical industry in Singapore. From developing strategies to ensuring compliance, these procedures ensure that products are kept safe, of quality, and effective.

The Reg Consultants Pte Ltd (TRC) provides regulatory consulting services in Singapore to assist local and overseas pharmaceutical and medical companies register their products locally. Get in touch with us for more assistance today.

As a global hub for pharmaceutical research, development, and manufacturing, Singapore prides itself on its stringent regulations that prioritise the safety, efficacy, and quality of pharmaceutical goods available within its borders. These strict guidelines help to safeguard public health by ensuring that residents have access to only the best and the safest products. However, this poses a challenge to pharmaceutical companies because navigating the complex registration process becomes even tougher, involving multiple authorities and compliance requirements. In this article, we’ll dive into the intricacies of registering pharmaceutical products in Singapore, as well as how a regulatory affairs subscription plan can help your company. 

1.1 The Role of Regulatory Affairs in Singapore’s Pharmaceutical Industry

Regulatory affairs refers to the field that deals with the guidelines and processes related to the development, manufacturing, registration, marketing, and post-marketing surveillance of pharmaceutical products in Singapore. Companies are expected to ensure compliance with local laws and regulations set by the Health Sciences Authority (HSA) and the Ministry of Health (MOH). It is an important aspect of the pharmaceutical industry in Singapore because it concerns the safety of public health. It can also contribute to the success and integrity of pharmaceutical companies selling their products in the region. 

❖ Ensure Compliance with Regulatory Requirements

Regulatory affairs professionals act as the bridge between pharmaceutical companies and regulatory authorities. They stay up-to-date with the latest regulations, guidelines, and laws, possess a deep understanding of the regulatory landscape and can interpret complex requirements to help your business adhere to them. 

These professionals will work closely with your company to develop comprehensive regulatory strategies, such as assess the regulatory implications of new products or changes to existing products, and provide guidance on how to comply with applicable health products regulations.

❖ Gain Market Access and Product Registration

Complying with regulatory guidelines is also crucial for pharmaceutical businesses planning to enter into new markets. While it is a strategic and important move for companies seeking global reach and growth, the regulatory process may become too complex for some. 

Regulatory service providers can then help to ensure compliance and obtain the necessary approvals to enter new markets by preparing and submitting regulatory dossiers specific to each country. 

In Singapore, maintaining compliance with our regulatory requirements can serve as a stepping stone. With our robust regulatory framework, well-established healthcare system, and alignment with international guidelines and standards, being able to comply with rules and regulations here enhances your business’s credibility, and can make obtaining regulatory approval in other countries much easier. 

❖ Ensure Safety and Quality

The biggest concern in the pharmaceutical industry is the safety and quality of products. With regulatory guidelines and processes, Singapore forces pharmaceutical companies to adhere to stringent safety standards and quality control measures to provide the safest and top-quality products to residents here. 

❖ Reputation and Trust

Compliance with regulatory requirements demonstrates that the products manufactured by a pharmaceutical company is safe, effective, and of high quality, as well as their commitment to patient safety and public health. This builds and maintains the reputation and trust of your company, which can translate into consistent revenue growth. 

Learn More: The Importance of Regulatory Affairs Management in the Healthcare Industry

REGULATORY FRAMEWORK IN SINGAPORE

2.1. Singapore’s Regulatory Authority

In order for your pharmaceutical business to reap the benefits of being compliant with regulatory guidelines in Singapore, it is important to first find out who governs regulatory affairs in the pharmaceutical industry here, as well as the steps needed to ensure compliance. 

The key regulatory body in charge of overseeing and regulating pharmaceutical products in Singapore is the Health Sciences Authority (HSA). As the national regulatory authority, the HSA plays a pivotal role in ensuring public health and safety. Its role and responsibilities include: 

❖ Assess and Approve New Product Registrations

HSA is responsible for the evaluation and approval of new pharma product registrations in Singapore. Products can include medical devices, therapeutic products, health supplements, and cosmetic products. HSA will review comprehensive data and information submitted by pharmaceutical companies to assess the products. If the products meet necessary standards for market authorisation, HSA will grant approval for import and/or sale. 

❖ Inspect, Audit, and Perform Post-Market Surveillance

To ensure that manufacturing processes, quality control systems, and distribution practices adhere to the Good Manufacturing Practices (GMP) and other relevant health products regulations, HSA will also conduct regular inspections and audits of manufacturing facilities and pharmaceutical companies. Post-market surveillance is also conducted to monitor the safety and effectiveness of pharmaceutical products available in the market. 

❖ Enforce Regulatory Control Measures

 HSA also has the authority to monitor and investigate cases of non-compliance and take appropriate action, such as impose penalties and/or sanctions when necessary. This includes addressing issues related to counterfeit drugs, unauthorised sales, and non-compliant manufacturing practices to ensure that pharmaceutical companies are complying with regulatory guidelines, protect public health and maintain the integrity of the healthcare system.

Learn More: 7 Steps to Solve Regulatory Issues

❖ Collaborate, Share Knowledge, and Train 

Apart from making sure that pharmaceutical companies are adhering to regulations imposed, HSA also actively engages in collaborations and partnerships with local and international regulatory agencies, industry stakeholders and healthcare professionals. They exchange knowledge, share best practices and stay updated with emerging trends and advancements in the pharmaceutical industry. 

HSA also participates in capacity building initiatives, providing training and guidance to companies and professionals to enhance compliance and patient safety. Pharmaceutical businesses can benefit from these sessions and bring back with them valuable insights that can help with their own compliance and practices. 

2.2. Regulatory Requirements for Pharmaceutical Companies

There are many aspects to the guidelines that the HSA has established, and they all serve multiple purposes. But together, these rules are aimed at protecting public health. Find out more about them below. 

❖ Product Information

Pharmaceutical companies must ensure that all claims made about their products are supported by scientific evidence, such as data from reliable clinical studies, and are not misleading or exaggerated. The claims should accurately represent the product’s indications, dosage, contraindications, and precautions.

Both the benefits and risks associated with the use of the products must also be presented fairly to ensure that healthcare professionals and consumers have access to the most comprehensive and unbiased information.

These must be supported by proper documentation and evidence, which must be provided to HSA upon request to demonstrate their scientific validity. 

HSA will then review the accuracy of claims, adherence to prescribing information, and the use of product names, logos, and branding, to determine whether the product should be approved for sale in the country. 

❖ Good Manufacturing Practice (GMP) Compliance

The GMP guidelines established by the HSA are based on international standards and are in line with the requirements of the World Health Organization (WHO). They cover a wide range of areas, including personnel, premises, equipment, documentation, production, quality control, storage, and distribution. The guidelines are as follows: 

• Personnel

Companies must employ trained and qualified personnel who possess the necessary knowledge and skills to perform their assigned tasks. Ongoing training should also be provided to ensure that their employees are aware of the latest GMP requirements. 

• Premises and Facilities

The design and maintenance of manufacturing facilities, including cleanliness, temperature control, amount of space, water systems, ventilation, and waste management systems, must work together to ensure a hygienic and safe manufacturing environment. 

• Equipment

Pharmaceutical companies must have appropriate equipment and systems in place to ensure that manufacturing processes are conducted accurately and consistently. The guideline includes requirements for equipment qualification, calibration, maintenance, and cleaning to prevent product contamination and ensure reliable production.

• Documentation

Comprehensive documentation, including standard operating procedures (SOPs), batch records, and quality control records, is a crucial component of GMP compliance. The guidelines specify the types of documents that must be maintained in order to ensure consistency, traceability, and accountability throughout the manufacturing process.

• Production

Guidelines detailing instructions for each stage of the production process, from the receipt of raw materials to the packaging and labeling of finished products are provided. They cover aspects such as material handling, process validation, in-process controls, and batch release procedures. Companies are expected to ensure that products are manufactured consistently and meet the required quality standards. 

• Quality Control

Pharmaceutical companies must have robust quality control systems in place to monitor and verify the quality of their products. This includes the testing, sampling, and analysis of raw materials, intermediates, and finished products, as well as stability testing to assess product shelf-life and storage conditions.

• Storage and Distribution

Pharmaceutical companies are required to adhere to storage and distribution guidelines to prevent product degradation and ensure that product quality is maintained throughout the supply chain. This includes paying attention to temperature control, labelling, and transportation conditions. 

❖ Safety and Efficacy Data

When applying for product registration, pharmaceutical companies are required to provide comprehensive data that shares more about a product’s safety, and whether it’s effective. Some key components include:

• Preclinical Data

Pharmaceutical companies must provide preclinical data from laboratory studies conducted in animals or in vitro experiments. The data should contain information on the product’s mechanism of action, pharmacokinetics, and toxicological profile.

• Clinical Trial Data

Companies must submit comprehensive data from well-designed clinical trials that evaluate the safety and efficacy of the pharmaceutical product. This includes data from Phase I, II, and III clinical trials, which assess the product’s safety profile, dosage range, effectiveness, and any adverse effects. The clinical trial data should adhere to Good Clinical Practice (GCP) guidelines and provide detailed information on study design, patient population, endpoints, statistical analyses, and adverse events.

• Quality Data

HSA requires detailed information on the product’s manufacturing processes, quality control measures, and stability studies. This data ensures that the product is consistently manufactured to meet quality standards and that its active ingredients and formulation remain stable over time.

• Comparative Data

In some cases, the HSA may require comparative data to be submitted. This demonstrates the superiority or non-inferiority of the product compared to existing treatments, helps to establish the product’s therapeutic benefits, and justifies its use in the market. 

• Safety Data 

Information on any known adverse reactions, contraindications, precautions, and warnings associated with the product must be provided. This ensures that healthcare professionals and patients can have a clear understanding of the product’s safety profile. 

❖ Quality Control Testing

Pharmaceutical companies are required to provide comprehensive documentation on the quality control testing conducted on their products. This documentation should demonstrate the company’s adherence to established standards, such as the Good Manufacturing Practice guidelines. 

It is also expected that companies conduct thorough tests, such as analytical testing, batch release testing, and stability testing, to assess the quality and consistency of their products. 

❖ Labelling and Packaging

Pharmaceutical companies in Singapore are subject to strict guidelines and regulations when it comes to labelling and packaging their products. Pharmaceuticals must be accurately and clearly labelled, packaged, and presented to protect public health and safety. 

• Labelling Requirements

– Product information, such as the name, active ingredients, strength, dosage form, and batch number, must be included. The manufacturer’s name, address, and license number must also be indicated. 

– The label must provide clear instructions regarding the indications and usage of the product, including any specific warnings, precautions, or contraindications. 

– The proper dosage and administration instructions must be clearly stated, including any special instructions for use, such as storage conditions or reconstitution requirements.

– The label should prominently display the expiry date of the product to ensure that it is not used beyond the specified period.

– If specific storage conditions are required, such as refrigeration, the label must indicate these instructions.

– Certain medications require a patient information leaflet (PIL) that provides additional information about the medication’s uses, side effects, and precautions. The PIL must be included in the packaging.

• Packaging Requirements

– Pharmaceutical products should be packaged in a tamper-evident manner to ensure the integrity of the product and to provide assurance to the consumer that the package has not been tampered with.

– Medications that pose a risk to children must be packaged in child-resistant containers to prevent accidental ingestion. These containers should be designed in a way that makes it difficult for young children to open them.

– Packaging materials should be compatible with the pharmaceutical product to prevent contamination or degradation. Special attention should be given to light-sensitive or moisture-sensitive products.

– All labelling and packaging information should be written in clear and legible fonts. In Singapore, English is the main language used for labelling, but bilingual labelling (English and one other official language) may be required for certain products.

REGULATORY AFFAIRS SUBSCRIPTION PLANS

3.1. What are Regulatory Affairs Subscription Plans?

In order to help pharmaceutical companies better navigate Singapore’s regulatory landscape, TRC has come up with  subscription plans that businesses can tap on for a more hassle-free pharma registration process. 

The  regulatory affairs subscription plans refer to services that specialise in providing regulatory information and updates to companies in need for regulatory support. Service providers are responsible for ensuring that products and operational processes comply with the relevant regulations and requirements set forth by the authorities. 

Subscription plans for regulatory affairs  covers critical area of compliance in business operation pertaining to market launch of pharmaceutical products and medical products such as :

❖ Regulatory Intelligence activities ( learn more about https://theregconsultants.com/why-is-regulatory-intelligence-exercise-crucial-for-pharma-companies-looking-to-expand-into-new-territories/ )

❖ Regulatory Training 

❖ Post Licensing support such as maintenance of licence as marketing authorization holder 

❖ Project Management as a Regional Regulatory Project Manager 

The specific features and offerings of regulatory affairs subscription plans may vary.

3.2. Benefits of these Plans

❖ Regulatory Compliance

Staying compliant with the ever-changing regulatory requirements is crucial for pharmaceutical companies. A subscription plan provides access to up-to-date information and resources, ensuring that the company remains in adherence to relevant regulations, guidelines, and standards. This minimises the risk of non-compliance, penalties, and delays in product approvals.

❖ Timely Updates

A regulatory subscription plan ensures that you’ll be provided with timely updates on regulatory changes. This allows the company to stay informed about new requirements and adjust processes and procedures accordingly. 

❖ Regulatory Intelligence

A subscription plan often includes access to regulatory intelligence tools and resources. These tools collect, analyse, and interpret regulatory data, enabling companies to gain valuable insights and strategic guidance. Pharmaceutical companies can proactively identify potential regulatory hurdles, assess the impact of new regulations on their products, and develop effective compliance strategies.

❖ Expedited  Approvals

Efficient regulatory affairs management can significantly expedite the approval process for new drugs or medical devices. With a subscription plan, companies receive comprehensive guidance on the regulatory requirements for submission, including the necessary documentation, data, and studies. Some regulatory service providers even handle the preparation and submission process entirely, reducing the time and effort required to bring products to market.

❖ Global Reach

Pharmaceutical companies often operate in multiple countries and need to comply with various regional regulatory frameworks. A subscription plan that offers global coverage ensures that companies have access to regulatory information and support across multiple jurisdictions. This facilitates market expansion and allows companies to navigate the complexities of different regulatory systems effectively.

❖ Independent License Holder

A third party, such as a regulatory consulting service, can be an independent license holder for your company’s products if you engage the provider to register your products in the region for you. 

As compared to a traditional model, this may serve as a better option for pharmaceutical companies in a foreign territory where there is no trusted partnership established as of yet. 

Independent Licence Holder vs Traditional Model

In a traditional model, your company has to assign marketing and distribution rights to a local partner, also known as distributor, exclusively. This agreement binds both parties for a minimum period of five years, and your distributor must provide a three-year forecast (with annual volume and price) to your company to secure this relationship. 

This may be an advantageous arrangement if your company:

• Is starting up in a new territory with little to no budget
• Wants to leverage on the distributor’s ability to build brand in the region

 

However, there are cons to this arrangement too. They include:

• Lengthy research and recruitment period when searching for a reliable distributor, potentially losing out lead time for product launches
• Risk of souring business relationships when you wish to transfer the licence
• Multiple agreements to manage when you have more than one distributor

 

In an independent licence holder model, pharmaceutical companies will pay a regulatory service provider for regulatory affairs management services. All roles and responsibilities of both parties will be spelled out, and the provider will serve as your business’s independent licence holder. They will have to abide by the instructions of the product owner, in this case, your company. Termination of the agreement can be done with a short notice (e.g. a week) without risk of affecting product sales in the territory. 

Pros of Independent Licence Holder Model

• Marketing authorisation is obtained faster 
• Companies do not need to worry about their compliance status in the event that they wish to find a new distributor 
• Able to sell the readily obtained MA to a designated distributor to recover the cost paid to a third party
• Able to have more distributors in the territory to market the products and maximise sales

 

Cons of Independent License Holder Model

• High costs involved
• Does not cover sales, marketing, and distribution of your products

 

Most Suitable for: 

• Companies who want to minimise conflicts and messy clean-up with a traditional model
• Companies with a decent amount of budget and wish to explore something new
• Companies who have executed such model before in another region
• Companies involved in a conflict of interest with the parent and/or sister company
• Companies without a local office but have plans to establish one

 

3.3. Case Studies

❖ Reduce Manpower Costs for a Distributorship Business

A company distributing both medical devices and supplements suffered losses during the COVID-19 pandemic and wanted to reduce manpower costs by dismissing non-profit-making departments. Seeing how regulatory affairs management is crucial, the company took up subscription plans for regulatory affairs with The Reg Consultants. The basic plan was within the company’s budget, helped to reduce overall costs, and the services provided were sufficient to cover everything the business needed. 

❖ Stabilise and Support an MNC’s Regulatory Affairs 

Due to high turnover rates and a constant change of management, the regulatory team in a well-established Spanish MNC with a regional sales and marketing office in Singapore suffered from a highly unstable regulatory environment. They wanted a stable yet flexible support that will help to save costs and kick start the registration of their new products. They took up the advance subscription plan with The Reg Consultants, which helped to sustain and stabilise their local operational activities while the company focused on regrouping internally. This led to significant progress and growth for the business. 

❖ Manage Adhoc Regulatory Tasks for an Italian Company to Help Them Improve Efficiency

An overseas Italian company with no sales and marketing office established locally was looking to launch new and improved forms of an existing product in the ASEAN region. They needed regulatory support from a consultancy firm but were concerned about inconsistent consultant charges, incomprehensive regulatory affairs services, and inefficient work. The Reg Consultants’ subscription plans for regulatory affairs provided all the services they required at a fixed price, which helped the business save time and control the amount of money spent on regulatory activities. This greatly improved the accuracy and efficiency of their internal regulatory planning. 

❖ Kick Start a Company’s Operations Locally While They Worked on Setting Up a Team

An established generics company in China wanted to set up their own sales and marketing office in Singapore. But the time taken to hire their own team will reduce their launch time significantly, affecting revenue and operations. They took up The Reg Consultants’ subscription plans to ride on our expertise to kick start some of their regulatory activities. This helped the company set up some basic regulatory framework, see some progress in the registration process, and allowed the business to focus on getting their team together. 

❖ Retrieve Marketing Authorisation Rights and Support a Middle Eastern Company’s Local Regulatory Activities 

A Middle Eastern company specialising in gastroenterology field has been operating successfully in Singapore for over five years. However, they have been working through a traditional distributorship model, in which marketing authorisation rights and sales and marketing rights were given to their distributors. The distributor was unable to push up annual sales volume and the company faced obstacles when attempting to transfer the rights back. With The Reg Consultants’ subscription plans for regulatory affairs, we managed to return all rights to the company and have been managing their local regulatory activities as their independent licence holder. 

3.4. Frequently Asked Questions

1. What is included in a typical regulatory affairs subscription plan? 

A typical subscription plan for regulatory affairs includes a fixed number of hours of selected services which includes the following  regulatory intelligence work, consultation services, updating of operational SOPs, maintenance of regulatory databases, as well as training. 

Contact The Reg Consultants to find out more about our regulatory affairs subscription plans. 

2. Can I register my products without the help of regulatory affairs professionals?

Yes. However, the process may be complicated. We recommend engaging regulatory consultants to help to support the initiatives to address the gaps earlier to ensure a smooth registration  process. 

3. Can I sell pharmaceutical or medical products in Singapore without registration?

All pharmaceutical or medical products imported or sold in Singapore must be registered.

4. What licence will I need to supply pharmaceutical or medical products in Singapore?

This depends on the product that your company wants to import or sell in Singapore. 

Contact us to get tailored solutions for your business and products. 

5. Should my company choose the independent licence holder model or opt for the traditional model route?

There are many pros and cons to each licence model. Independent licence models can be a more advantageous solution if you wish to have more control over the sale of your products. 

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Supplying pharmaceutical or medical products in Singapore requires compliance with specific regulatory guidelines and a valid registration. To ensure compliance and successful registration and approval, consider investing in a subscription plan.

The Reg Consultants offers comprehensive regulatory affairs management services to businesses intending to import or sell their products in Singapore and the surrounding countries. Our experienced veteran consultants have different areas of expertise, such as in regulatory affairs, quality management, pharmacovigilance, and market access. Contact us today to find out more about our solutions.