Entering the pharmaceutical market in Singapore presents a complex web of regulations and requirements that companies must navigate. Market access refers to the process of making pharmaceutical products available to those who need them at the right price and time. The process involves various activities focused on ensuring patients receive the treatments they require. At its core, pharma market access revolves around two main elements: pricing and reimbursement. For any business looking to thrive in this competitive landscape, understanding the nuances of pharmaceutical market access is crucial. In this article, we’ll explore the essential factors that pharmaceutical companies should consider, from regulatory frameworks to effective pricing strategies.

Regulatory Landscape

The Singapore regulatory framework for pharmaceuticals is governed by several key authorities, with the Health Sciences Authority (HSA) playing a central role. This body is responsible for evaluating and approving medicines and medical devices, making sure they meet rigorous safety, quality, and efficacy standards. For companies looking to enter the market, preparing detailed documentation that aligns with the HSA’s strict requirements is crucial. Familiarity with these regulatory requirements is vital, as they can greatly influence both the timeline and the success of product approvals.

Reimbursement Policies

Understanding reimbursement policies is crucial for pharmaceutical companies seeking successful market access. Getting products listed on the national health authority’s drug formulary ensures they are available to patients. Achieving market access means that a product is approved for use and eligible for reimbursement by national healthcare systems or insurance providers. In Singapore, the Government and various healthcare institutions have set up specific mechanisms for reimbursing new medicines. Companies need to evaluate the cost-effectiveness of their products and how they fit with the country’s healthcare priorities. By navigating these reimbursement processes, businesses can develop strategies that enhance their market access efforts and increase their chances of success.

Here’s a list of key reimbursement policies in Singapore that can assist pharmaceutical companies, along with brief descriptions and information on how they can get their drugs listed:

1. Drug Formulary Listing

The Drug Formulary is a list maintained by the Health Sciences Authority (HSA) and the Ministry of Health (MOH) that includes medicines approved for use in Singapore’s public healthcare system. Listing on this formulary ensures that a drug is accessible to patients at subsidised rates.

Companies must submit comprehensive clinical and economic evidence demonstrating their product’s safety, efficacy, and cost-effectiveness. The Drug Advisory Committee evaluates this submission and makes recommendations to the MOH for listing approval.

2. Health Technology Assessment (HTA)

HTA evaluates the clinical effectiveness and cost-effectiveness of new health technologies, including drugs, to inform reimbursement decisions. This process helps determine the value a drug provides relative to existing treatments.

Companies should prepare data from well-designed clinical trials and economic evaluations. Engaging with the Health Technology Assessment (HTA) agency early in the process can provide guidance on the required data and submission format.

3. Medisave and MediShield Life

Medisave is a national savings scheme that allows Singaporeans to set aside part of their income for medical expenses. MediShield Life is a basic health insurance plan that helps cover large hospital bills and certain outpatient treatments.

A drug must meet specific clinical criteria to be covered under Medisave or MediShield Life. Companies must demonstrate how their product aligns with existing treatment protocols and patient needs and submit the necessary documentation to the MOH for evaluation.

4. Clinical Practice Guidelines (CPGs)

CPGs are evidence-based recommendations developed by expert panels to guide healthcare professionals in the treatment of specific conditions. Drugs that are included in CPGs may receive better visibility for reimbursement consideration.

Pharmaceutical companies can collaborate with medical associations and healthcare professionals to ensure their drug is included in relevant CPGs. Providing clinical evidence supporting the drug’s use in accordance with these guidelines can enhance its chances for inclusion.

5. Specialist Drug Programme (SDP)

The SDP is designed to facilitate access to innovative therapies that may not yet have been formally approved or listed but show promise in treating serious conditions. This programme allows for early access under specific conditions to include their drug in the SDP by presenting compelling clinical data and justifying the need for early access. A review process evaluates the product’s potential benefits against risks.

Pricing Strategies

Singapore is largely a tender-based market with a pricing strategy that is stratified between meeting tender and private needs. Companies may need to conduct their own on-the-ground study with the support of local distributors, engage a market access specialist, or obtain IMS data pertaining to the relevant therapeutic area on which they are going to benchmark their pricing. While it is always good to be able to obtain a B2B price, at times, this can be challenging, which makes it much easier to get a consumer price and work out the base cost. Knowing how to position products effectively in terms of pricing not only impacts market entry but also affects long-term sustainability in this dynamic market.

Market Entry Barriers

Apart from regulatory challenges, It’s crucial to study the local gold standard treatment for a particular indication culture of the people here to appropriately select the type of products to enter Singapore. Some companies are focused on introducing new drugs into Singapore rather than generic drugs due to the lack of profit margin or volume to meet the country of origin’s volume.  Recognising these barriers early on is crucial for developing effective market access strategies. Engaging pharma regulatory services can help companies navigate these complexities more effectively. Proactively tackling these challenges allows the companies to facilitate a smoother entry into the market and better position themselves for success in the competitive pharmaceutical landscape.

Market Access Strategies

Companies must adopt robust market access strategies to achieve and sustain pharmaceutical market access in Singapore. This includes engaging with stakeholders such as KOLs, holding symposiums, participating in congresses, and collaborating closely with procurement agencies such as the Ministry of Health or the Group Procurement Office. By understanding the complexities of the local market and implementing tailored strategies, businesses can significantly improve their chances of successful product registration and establish a lasting presence in the market.

In conclusion, navigating Singapore’s pharmaceutical market access landscape requires thorough knowledge of the regulatory environment, reimbursement policies, pricing strategies, and potential entry barriers. Leveraging expertise in regulatory affairs and implementing effective market access strategies can significantly enhance a company’s chances of success.

If you’re ready to tackle the complexities of pharmaceutical market access with confidence, reach out to The Reg Consultants today. Our team is here to offer tailored regulatory affairs services and insights to help you thrive in the Singaporean market.

Chinese Medicine, or Chinese Proprietary Medicine (CPM), holds a significant place in the wellness landscape, particularly in Singapore. However, the use of certain ingredients within these medicines is strictly regulated to ensure safety and effectiveness. It’s essential for manufacturers, practitioners, and consumers to understand which substances are prohibited, the health risks they may pose, and the regulatory framework in place. In this article, we’ll explore the regulations governing CPM and what these restrictions mean for everyone involved.

Prohibited CPM Substances 

In Singapore, regulations around Chinese medicine are quite strict, specifically listing ingredients that cannot be included in CPM. Products manufactured, imported, or sold locally must not contain prohibited substances, including synthetic drugs and any items listed under the Poisons Act—unless they’re naturally occurring substances allowed within specified limits. For instance, Aristolochia species, known for nephrotoxic effects, are banned due to their potential for severe health complications. These regulations are designed to protect consumers from the risks associated with unverified ingredients often found in traditional remedies.

CPM Substance Limits and Safety Standards

A. Limits on Naturally Occurring Substances in CPM

• Aconite and its alkaloids: Max dose of 60 mcg daily.
• Amygdalin: No limit.
• Berberine and its salts: No limit.
• Boric acid, sodium borate: Limited to 5% in any combination.
• Ephedra and its alkaloids: Less than 1%.
• Lobelia and its alkaloids: Below 0.1%.
• Lovastatin: Less than 1%.
• Methoxsalen: No limit.
• Phenethylamine and its salts: Max 300 ppm.
• Tetrahydropalmatine: Limited to 19 mg daily.

B. Toxic Heavy Metals and Microbial Limits

Products must adhere to heavy metal limits to protect consumers from toxic exposure:

• Arsenic: 5 ppm
• Cadmium: 0.3 ppm
• Lead: 10 ppm
• Mercury: 0.5 ppm

For microbial safety, CPM must undergo testing to ensure it meets stringent microbial count standards. In oral CPM, the total aerobic microbial count should not exceed 10⁵ CFU/g or ml, and certain bacteria like E. coli and Salmonella must be absent. Whereas, for topical CPM, lower microbial limits apply, ensuring it’s safe for skin application.

C. Animal-Derived Ingredients

Products containing animal-derived substances must comply with guidelines for Transmissible Spongiform Encephalopathy (TSE) to prevent neurological diseases. Products with ingredients from endangered species must also obtain CITES permits.

These strict regulations ensure that CPM products meet safety and quality standards, offering protection to both consumers and the ecosystem.

CPM Health Risks Associated with Prohibited Substances

The health risks associated with the use of prohibited substances in CPM can be severe. For instance, toxic ingredients can cause both immediate and long-term health problems, including organ damage and a heightened risk of cancer. Many consumers may not even realise the dangers these substances pose. Moreover, the implications reach beyond individual health, as the widespread use of unsafe ingredients can lead to greater public health issues.

CPM Regulatory Oversight

Regulatory bodies play a crucial role in keeping CPM safe. In Singapore, the Health Sciences Authority (HSA) is responsible for enforcing regulations on the ingredients used in Chinese medicine. They regularly review and update guidelines to incorporate the latest research and emerging health risks. This oversight ensures that only safe and approved substances are used in CPM formulations, thus providing a layer of protection for consumers. To maintain compliance and protect their reputation, manufacturers need to stay informed about these rules, including those related to nutraceutical regulations.

Consumer CPM Awareness

Consumer awareness is vital for the safe use of CPM. Many individuals may not realise the potential dangers of consuming products that contain prohibited substances. That’s why education campaigns are so important; they help emphasise the need to check ingredient lists and understand the regulatory framework. By raising awareness about the health risks associated with CPM, consumers can make informed choices about the products they use, ultimately leading to better health outcomes.

CPM Compliance and Enforcement

For CPM manufacturers and practitioners, staying compliant with regulations around prohibited substances is crucial. This means not only following the laws established by regulatory authorities but also actively practising self-regulation. Practitioners should keep their knowledge of CPM regulations and best practices up to date. At the same time, manufacturers need to enforce strict quality control measures to ensure that banned substances are not included. Compliance protects consumers and helps maintain the integrity of the entire industry.

In conclusion, understanding the regulations surrounding Chinese medicine is essential for everyone involved in the industry, from manufacturers to consumers. Prohibited substances can pose serious health risks, so being aware of them is necessary for making informed decisions. Regulatory bodies like the HSA play a crucial role in enforcing these restrictions and protecting public health. If you’re seeking guidance on navigating the complexities of regulatory affairs in CPM, The Reg Consultants are here to help you. Reach out today for expert support and tailored regulatory affairs services to ensure your products meet all necessary standards in Singapore.

 

In the ever-evolving healthcare landscape, managing change notification to registered medical devices is critical to maintaining their safety and performance in accordance with Essential Principles Checklist of Standards claims. With regulations becoming stricter, manufacturers and stakeholders need a clear understanding of the necessary procedures involved in handling updates, modifications, and post-registration changes. This article breaks down the key aspects of managing changes to registered medical devices in Singapore, offering insights into regulatory requirements and best practices to help you stay compliant and keep your devices performing at their best.

Types of Changes

Change notification to registered medical devices can encompass various modifications, ranging from minor adjustments to significant alterations. These might include software upgrades, design modifications, material changes, or even notification updates. It’s essential to understand the type of change, as each one can require different levels of regulatory review. Identifying the nature of the modification helps manufacturers take the proper steps to stay compliant and keep their devices safe and reliable.

Regulatory Requirements

When the product owner initiates a change notification for a locally affected medical device, the immediate steps to take include performing a gap analysis between the registered information pertaining to the medical device versus the changes made by the product owner. The change should be classified as technical, administrative or notification-based, according to GN 21, GN 24 and GN 25 as applicable. 

Next, prepare the requirement documentation required under each category of change before submitting to HSA. Following these steps will ensure that you have all the necessary documents to confirm that the changes have been validated and will not affect the safety and performance of the device for its intended users in the local market. Clear and timely communication with regulators helps prevent delays and ensures the modification process runs smoothly.

Risk Assessment

Conducting a risk assessment according to ISO 14971 is an integral part of managing medical device changes. This change control process involves evaluating how a modification might affect the device’s safety and performance. Identifying potential risks allows manufacturers to take the right measures to address them. A thorough risk assessment not only helps protect patient safety but also shows compliance with regulatory standards, reflecting the manufacturer’s dedication to maintaining high-quality products. 

Post-Market Surveillance

Post-market surveillance plays a significant role in monitoring the safety and performance of the modified devices. This ongoing process involves collecting and analysing data from users and healthcare professionals to identify any potential issues that may arise after a device has been modified. With strong surveillance practices in place, manufacturers can quickly address safety concerns and keep their devices aligned with regulatory standards throughout their life cycles. If required, a field safety notice (FSN) may be issued.

Managing changes to registered medical devices is a complex but vital process that involves various steps, including understanding regulatory demands, conducting risk assessments, maintaining detailed documentation, and ensuring effective post-market surveillance. By following these guidelines, manufacturers can successfully navigate the intricacies of device registration, modifications, and even pharma market access.

For expert assistance with navigating these challenges and ensuring compliance, turn to The Reg Consultants. We provide customised regulatory affairs services tailored to your unique requirements.

Reach out to us today to find out how we can assist you!

In Singapore’s bustling cosmetic market, the allure of new and innovative products can sometimes distract businesses from the crucial need for regulatory compliance. While consumers eagerly seek the latest beauty trends, many businesses may unknowingly supply un-notified cosmetic products. This oversight not only poses risks to consumer safety but also poses serious consequences for businesses, including hefty fines and damage to their reputation. In this article, we’ll uncover the hidden dangers of un-notified products and highlight why adhering to notification requirements is essential.

Regulatory Requirements

In Singapore, the notification requirements for cosmetic products are clearly defined. Before launching a new product, businesses must notify their cosmetic product with  Health Sciences Authority (HSA). This process ensures that all cosmetics meet essential safety standards and comply with local regulations. Similarly, un-notified health supplements face the same level of scrutiny, as they must follow specific notification requirements to protect consumer health. Additionally, nutraceutical regulations play a vital role in ensuring that health-related products are safe and effective. By understanding these regulations, companies can avoid the pitfalls linked to un-notified products and play a critical role in safeguarding consumer well-being.

Penalties for Non-Compliance

Failing to comply with cosmetic product notification can lead to serious repercussions. Businesses supplying un-notified cosmetic products face hefty penalties for non-compliance. They must stop the sale of these products and take all reasonable steps to recall them. Under the Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations 2007, companies could face fines of up to $20,000 and/or a prison sentence of up to 12 months. Such penalties can significantly impact a company’s financial health and growth, so adhering to these regulations is crucial for maintaining a successful business. The same strict penalties apply to un-notified health products, underscoring the importance of compliance across all product categories.

Consumer Safety Concerns

One of the biggest concerns with un-notified cosmetic products is their potential risk to consumer safety. Without proper notification, there’s no guarantee that these products have undergone thorough testing for safety and effectiveness. This uncertainty can result in adverse reactions and health risks for consumers. Therefore, dealers and importers of cosmetic products have the ultimate responsibility to ensure their products, whether cosmetics or health supplements, are safe for public use. Complying with local regulatory requirements is vital for protecting consumer well-being in both sectors. Health Sciences Authority regularly publish updates on consumer safety news about unsafe products such as the ones below:

• https://www.hsa.gov.sg/consumer-safety/articles/details/dubious-weight-loss-products
• https://www.hsa.gov.sg/consumer-safety/articles/details/magic-water-facial-solution-skin-peeling-chemical-burns
• https://www.hsa.gov.sg/consumer-safety/articles/details/staying-safe-cosmetic-products

Impact on Business Reputation

The consequences of supplying un-notified cosmetic products go beyond regulatory penalties and safety risks; it can also severely impact a business’s reputation. In an age where consumers are more conscious about product safety and transparency, failing to comply can erode trust and credibility. Negative publicity related to non-compliance can tarnish a company’s image, making it hard to win back consumer confidence. Businesses need to prioritise compliance to avoid penalties, safeguard their reputation, and maintain customer loyalty, particularly in markets filled with cosmetic and health products.

Compliance Strategies

To reduce the risks linked to un-notified cosmetic products, businesses should embrace effective compliance strategies. This involves staying up-to-date with regulatory changes, establishing strong internal processes for product notification, and seeking professional regulatory affairs services when necessary. By cultivating a culture of compliance within their organisations, companies can significantly lower non-compliance risks and ensure that their cosmetic and health products meet the required safety standards.

Navigating the landscape of cosmetic products in Singapore requires a thorough understanding of regulatory requirements and a genuine commitment to consumer safety. Prioritising compliance with notification requirements helps businesses shield themselves from penalties, protect their reputation, and, most importantly, ensure consumer safety. As the demand for cosmetic and health products continues to rise, companies must be proactive in their compliance efforts. Partnering with experienced regulatory affairs service providers can provide invaluable support and peace of mind for those needing guidance in regulatory affairs and the complexities of product notification. 

Contact The Reg Consultants today to ensure your products are compliant, safe, and ready for market success. Our expert team is here to assist you every step of the way. Head to our website for more information on what we offer!

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!

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.