How A Regulatory Affairs Subscription Plan Can Benefit Your Company
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.
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:
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.
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.
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.
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.
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:
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.
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.
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.
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.
– 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.
– 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.
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.