Are you considering bringing your Chinese medicine products to Singapore? With a clear regulatory framework, zero registration fees, and swift evaluation timelines, Singapore presents an exciting opportunity for Chinese companies aiming to expand into Southeast Asia. Let’s explore the key differences in regulations between China and Singapore—and how The Reg Consultants (TRC) can guide your seamless entry into this promising market.

China vs. Singapore: A Quick Regulatory Comparison on How Chinese Medicine is Regulated
China: National Medical Products Administration (NMPA) oversees Chinese medicine, which is mainly classified as traditional Chinese patent medicine. The regulatory process is rigorous, requiring extensive safety and efficacy data. Products with therapeutic claims must undergo clinical trials and detailed documentation reviews.

Singapore: Health Sciences Authority (HSA) regulates Chinese medicine under the Chinese Proprietary Medicine (CPM) category. This includes oral, topical, or inhaled products based on traditional principles. Unlike China, no clinical trials are needed, offering a streamlined and efficient process that maintains high safety and quality standards.

Registration Pathways and Timelines
China: For therapeutic products, the regulatory process spans multiple steps—clinical trials, lab testing, and safety assessments. Timelines often stretch from 2 to 5 years, making market entry a lengthy commitment.

Singapore: The evaluation process for CPM products is notably faster—approximately 60 working days. Better yet, there are no registration fees, making Singapore a cost-effective and accessible market for expansion.

Documentation requirements:
China:  Extensive clinical, safety and GMP data

Singapore: Leverage on country of origin clinical and safety data. Data are more focused on CMC perspective.

Why Singapore is Your Gateway to Southeast Asia
1. Simplified and Cost-Effective Registration
Singapore offers a straightforward regulatory pathway with unparalleled advantages for Chinese manufacturers:
Evaluation in Just 60 Days: HSA expedites evaluations for CPM products without sacrificing quality or compliance.
Zero Registration Fees: By removing registration costs, Singapore reduces financial barriers for companies entering the market.

2. Practical Documentation Requirements
Singapore’s approach to documentation emphasizes practicality, minimizing administrative burdens for manufacturers:

Formulation and Ingredient Safety: Provide clear details about your product’s composition.
Manufacturing Standards: Submit quality control and safety protocols to meet GMP standards.

Ready to bring your Chinese medicine products to Singapore? Contact TRC today and let’s embark on this exciting journey together!
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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!

Brazil pharmaceutical companies offer a diverse and innovative portfolio of products. However, due to geographical distance, most companies focus on developing their market within Brazil and the U.S. There are many compelling reasons for Brazilian companies to consider expanding into Singapore and other ASEAN countries, where they can leverage strategic regulatory advantages and market opportunities that support efficient entry and growth.

Regulatory Synergies: Singapore and Brazil

One of the key regulatory advantages for Brazilian companies looking to enter the ASEAN market is that Brazil’s health regulatory authority, ANVISA, is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Many ASEAN countries, including Singapore, require PIC/S GMP compliance, allowing Brazilian companies to bypass additional inspections during the registration process. This waiver can significantly reduce lead times in regulatory approval, giving Brazilian companies a quicker route to market.

Climate Compatibility: Shared Zone IVb Stability Requirements

A unique advantage Brazil holds is its geographic location in Zone IVb, which aligns with ASEAN’s required climatic stability conditions for pharmaceutical products. This means that Brazilian companies can use existing stability studies, avoiding the need for additional testing specific to the ASEAN region. This shared climatic zone can result in considerable cost savings on stability studies and compliance, giving Brazilian products a competitive edge in terms of time and expense.

Comparing Regulatory Processes: Brazil vs. Singapore for Generic and New Drug Registration

While there are similarities, it’s essential for Brazilian companies to understand the regulatory differences between Brazil and Singapore, especially regarding generic and new drug registration. Below are key considerations that companies should factor into their ASEAN market expansion strategy.

1. Registration Pathways

In both Brazil and Singapore, the registration pathway differs significantly for new drugs versus generics. For instance:

New Drugs: In Singapore, Health Sciences Authority (HSA) offers a structured pathway for innovative and new drugs, which may include priority review  if the drug is deemed essential and lacks alternatives. In contrast, ANVISA in Brazil also has a pathway for new drugs, though companies may face longer timelines due to a multi-stage evaluation process.

Generics: The process for registering generics tends to be faster in both Brazil and Singapore, but while ANVISA requires proof of bioequivalence and local testing, HSA may accept certain international data, reducing redundancy and potentially expediting registration for companies with existing global dossiers.

2. Evaluation Timelines

Evaluation timelines vary widely:

In Brazil, ANVISA’s timelines can range from six months to two years depending on factors such as product type and completeness of the initial submission. Backlogs can also affect timelines, particularly for new drug applications.

HSA is known for shorter timelines, often ranging from nine to eighteen months for both new drugs and generics, especially for applications that meet international standards and are well-documented. Singapore also offers prioritized processing for essential medications, which may benefit companies with innovative therapies.

3. Documentary Requirements: Common Technical Document (CTD)

Both Singapore and Brazil use the CTD format, but specific requirements within the document vary, particularly for Modules 2-5:

Module 2 (Quality Summary): In Singapore,  HSA requires a comprehensive QoS which may differ from ANVISA’s requirements.

Modules 3 to 5: For new drugs, Brazil and Singapore both demand comprehensive preclinical and clinical data, but Singapore may accept foreign clinical trial data if it’s from recognized health authorities, whereas ANVISA may require supplementary data to align with Brazilian standards.

4. Stability and Climatic Zone Requirements

Given the shared Zone IVb classification between Brazil and ASEAN countries, Brazilian companies can often use existing stability studies for Singapore, eliminating the need for additional stability testing. This alignment is particularly advantageous for generics, as it simplifies compliance with local stability requirements in Singapore.

5. Labeling and Language Requirements

Singapore mandates labeling in English, and specific products may require simplified language for consumer understanding. Brazil similarly requires Portuguese labeling for domestic sales.

 

Making Expansion Decisions Easier: A Simple Regulatory Checklist

For Brazilian companies considering expansion into the ASEAN market, the following checklist can support a preliminary regulatory assessment, helping to identify both potential hurdles and advantages:

• Registration Pathway: Assess whether the registration pathway aligns with your product type, as requirements may differ significantly between new drugs and generics.
• Evaluation Timeline: Consider the estimated evaluation timeline for product approval, which can vary based on the specific ASEAN regulatory authority’s processes and the complexity of the product type.
• Technical Dossier Requirements (M2-M5): Review the dossier sections required for submission in ASEAN, particularly Modules 2 to 5 of the Common Technical Document (CTD). This assessment should take into account if the product is a new drug or a generic, as requirements may differ.
• Labeling Requirements: Ensure compliance with ASEAN-specific labeling requirements, which often include language adaptations and specific formatting to meet local standards.

By considering these key points, companies can conduct initial regulatory intelligence to streamline the expansion process. If your company is ready to enter the ASEAN market, The Reg Consultants (TRC) is available to provide expert regulatory support, helping you navigate these requirements with ease.

Feel free to check out other relevant articles:

https://theregconsultants.com/overcoming-the-challenges-of-registration-of-a-generic-drug-in-singapore/

https://theregconsultants.com/why-is-regulatory-intelligence-exercise-crucial-for-pharma-companies-looking-to-expand-into-new-territories/

https://theregconsultants.com/why-is-regulatory-intelligence-exercise-crucial-for-pharma-companies-looking-to-expand-into-new-territories/

https://theregconsultants.com/5-self-check-questions-for-pharma-market-access-in-singapore/

 

 

The pharmaceutical landscape is constantly changing, with countries taking different approaches to ensure the safety and effectiveness of medications. China and Singapore are two vibrant markets experiencing an increasing demand for innovative drugs. However, the regulatory environments in both countries can be quite complex, posing challenges for those unfamiliar with the processes. This guide highlights the key differences and similarities in their pharmaceutical regulations. From regulatory frameworks and approval processes to market access and post-market surveillance, discover how both nations safeguard consumer drug safety and efficacy.

As more and more Chinese companies are looking to expand their pharmaceutical business abroad, Singapore could serve as a good base to start off with in the ASEAN region with clearly established guidelines and as a maturity level 4 agency recognized by WHO, having your dossier evaluated by HSA could indirectly mean that your product is supported by robust quality, clinical and safety data to support the intended usage accordance to approved indications.

You might wish to check out: https://theregconsultants.com/market-entry-guide-for-china-pharmaceutical-companies-to-enter-singapore/ for more information on some key barriers that you should work on.

Regulatory Frameworks

China’s primary regulatory body is the National Medical Products Administration (NMPA), responsible for managing pharmaceutical regulations. It formulates and organises the registration of pharmaceutical products, reviews applications, and decides whether to approve or reject them. The Drug Evaluation Centre (CDE) under the NMPA handles the review of clinical trials, marketing authorisation applications, and any supplementary or re-registration requests. Additionally, the Chinese Food and Drug Administration (CFDA/CNDA) oversees the safety and management of food, medical devices, health products, cosmetics, and drugs, operating directly under the State Council.

In contrast, Singapore’s Health Sciences Authority (HSA) serves as the key regulatory agency for medical and biological drugs. HSA adopts a streamlined approach, prioritising efficient regulation while upholding safety standards.

Understanding these regulatory frameworks is crucial for any company looking to navigate the complexities of country-specific drug regulations.

Approval Processes

When it comes to the pharmaceutical approval process, there are notable differences between the two nations. In China, new drug approvals often take longer due to rigorous clinical data requirements and comprehensive review procedures. However, recent reforms have been initiated to expedite drug approvals and bring it more in line with international standards. Conversely, Singapore offers a more streamlined approval pathway, enabling companies to get new pharmaceuticals to obtain marketing authorisation faster. This efficiency is especially attractive for businesses looking to gain pharma market access in a competitive environment.

Clinical Trial Requirements

Clinical trial requirements differ quite a bit between China and Singapore. In China, the regulatory landscape demands strict adherence to local standards, often leading to lengthy approval processes. NMPA requires extensive clinical data, which can be a challenge for international companies. In contrast, HSA has created a framework that supports clinical research, offering more flexibility and efficiency in trial designs. Singapore accepts foreign clinical data, which minimises the requirements to conduct local trials, unlike other neighbouring countries.

For new drug applications, most Chinese companies would have to register their product with US FDA making it an advantageous approach to enter Singapore via an expedited pathway with shorter time to market. The key point is that the application should be submitted within 3 years from date of approval and the dossier set as well as the proposed indications should be similar to what is proposed for Singapore registration.

Understanding these differences is crucial for companies looking to effectively plan their clinical strategies in both markets.

Market Access and Pricing

Drug market access strategies vary significantly between China and Singapore. China, with its large population and growing healthcare demands, presents a complex market that can be difficult to navigate. NMPA has established detailed pricing mechanisms and reimbursement frameworks, which require companies to conduct thorough market analysis. In Singapore, The Ministry of Health (MOH) maintains a list of subsidised drugs under the List of Subsidised Drug and Medication Assistance Fund (MAF). Drugs are categorised into different tiers based on their clinical efficacy and cost-effectiveness for treating common conditions. Although smaller, it is often more predictable, making it an appealing choice for pharmaceutical companies looking to expand into new markets.

Post-Market Surveillance

Post-market surveillance of pharmaceuticals is essential for maintaining drug safety once products are on the market. In China, NMPA uses stringent pharmacovigilance systems to track adverse effects and manage safety risks, requiring mandatory reporting from both healthcare professionals and companies. Similarly, Singapore’s HSA places a strong emphasis on drug safety through its comprehensive post-market surveillance protocols. This includes timely data collection and analysis to spot any potential issues with the pharmaceuticals in circulation.

You may also refer to the quick table below highlighting the regulatory similarities and differences between both countries for your quick access:

Navigating pharmaceutical regulations in China and Singapore requires a keen understanding of the factors discussed. For businesses looking to thrive in these markets, leveraging expert pharma regulatory services can be a game-changer. If you need guidance on registering pharmaceutical products or accessing these promising markets, The Reg Consultants can provide the support you need. With our experienced team of experts, we can assist you through every step of the registration process, ensuring a smoother journey toward compliance and success.

Contact us to learn more about our services and how we can help you get started today.

Accessing life-saving treatments can be challenging, particularly for those living with rare diseases. In Singapore, as in many other regions, orphan drugs — medications specifically created to treat these rare conditions — come with unique challenges regarding availability and cost. In this guide, we delve into the complex issues surrounding orphan drugs and offer a closer look at Singapore’s current pharma market access landscape.

Definition and Scope

According to the Medicines (Orphan Drugs) (Exemption) Order, rare diseases are life-threatening or severely debilitating conditions that affect fewer than 20,000 people. Orphan drugs in Singapore are defined as medicinal products that a doctor or dentist has identified as essential for treating a rare disease when no effective substitute is available. These drugs typically haven’t been licensed under the Medicine Act but have received approval from health authorities in their country of origin or other countries where they have been used.

While the prevalence of rare diseases in Singapore is relatively low compared to more common health issues, the impact on patients and their families can be significant. The rarity of these conditions makes rare diseases access and the development of effective treatments particularly challenging.

Research and Drug Development Challenges

Developing orphan drugs involves several significant hurdles. Pharmaceutical companies often face high costs and technical difficulties due to the small patient populations involved. Research and development (R&D) for these drugs requires substantial investment, yet there is no guarantee of a large market. The financial risks, coupled with complex clinical trial requirements, can discourage investment in orphan drug development. Consequently, many promising treatments never make it to market, leaving patients with few options.

Regulatory Framework

Singapore currently lacks orphan drug-specific registration guidance. However, under the Medicines (Orphan Drugs) (Exemption) Order, importers can bring in and supply these drugs without a product licence, provided that a doctor or dentist prescribes them for a patient under their care. These drugs must be stored in a hospital and managed by a custodian, who must be a physician, dentist, or pharmacist appointed by the hospital. Doctors or dentists needing these drugs for treatment must request them from the custodian. Additionally, while drug developers often benefit from expedited approval processes and incentives for the development and registration of pharmaceutical products, there are currently no regulatory incentives for these drugs in Singapore.

Cost and Affordability

One of the significant barriers to accessing orphan drugs is their high cost. Because these drugs are developed for small patient populations, the development expenses are spread across fewer individuals, leading to higher prices. In Singapore, like in many other countries, this places a financial burden on both patients and the healthcare system. To help address this, the Ministry of Health and SingHealth Fund established the Rare Disease Fund (RDF), a charitable fund that combines community donations with government matching contributions to support Singaporeans with rare diseases who need expensive treatments. However, the funding currently covers eight medications for five conditions.

Patient Advocacy and Support

Patient advocacy groups play a vital role in improving access to the drugs. These organisations work tirelessly to raise awareness, support affected families, and push for policy changes. In Singapore, patient groups are instrumental in bringing attention to the needs of those with rare diseases and advocating for regulatory and financial reforms. Their efforts help create a more supportive environment for accessing treatments and drive meaningful changes in policy and practice.

The challenges of accessing orphan drugs and treating rare diseases in Singapore are part of a broader global issue involving access and affordability. Overcoming the abovementioned hurdles requires collaboration among policymakers, healthcare providers, and patient advocates. For those seeking expert guidance on pharma regulatory services and market access, The Reg Consultants in Singapore provides valuable insights and support to help navigate these intricate processes. 

Get in touch with us today to discover how we can assist with your needs.

 

Entering a new market like Singapore can indeed be a strategic move for Chinese pharmaceutical companies expanding into Southeast Asia. Today TRC would like to highlight 6 key areas from a regulatory perspective:

1. Quality of the CMC documents- Drug Substance

 2. Quality of the CMC documents- Drug Product

5.Language Barrier-  Dossier written in  simplified Mandarin should be translated and verified in a way that the content reflects what is written in the original language and official documentation such as Proof of GMP, approval letters should be authenticated by the foreign embassy or consulate of the country of origin. 

6. Marketing Authorization Requirements–In Singapore, only a local registered entity can hold the marketing authorization for pharmaceutical products. This means that companies seeking to market their products in Singapore must either establish their own legal entity in Singapore or engage a consultant who operates locally.

The MAH is responsible for ensuring compliance with regulatory requirements throughout the lifecycle of the product. This includes responsibilities such as product registration, pharmacovigilance, labeling and advertising compliance, and maintaining a quality management system.

To learn more about the responsibilities of a MAH, please visit: https://theregconsultants.com/responsibilities-of-a-marketing-authorization-holder-mah/

With that we have concluded key areas to evaluate prior to entering the Singapore market, if you need help and support to evaluate your dossier for registration in Singapore, please feel free to get in touch: https://theregconsultants.com/contact-us/

 

 

 

All overseas manufacturing sites are subjected to GMP conformity assessment by the local authority. GMP conformity assessment is in support a therapeutic product registration. Only local registered entity in Singapore can support the GMP conformity assessment application. The cost and timeline is dependent on the pathway in accordance to the pathway.

 

What is GMP conformity assessment?
GMP conformity assessment or Overseas Audit Program Assessment refers to evaluation of a new overseas manufacturing site in compliance to established GMP guidelines. Singapore being part of PIC/S scheme member countries adopt the PIC/s standard for Good Manufacturing Practices for Medicinal Products.

 

1st pathway : GMP Documentary Evidence Verification (DEVA)
This pathway is only feasible for proof of GMP compliance that are issued by PIC/S member authority. Acceptable proof of GMP compliance includes manufacturing license, GMP certificate and CPP issued in WHO format.
Applicant would need to ensure that the submission of the proof of GMP compliance is in English language, original scanned colour copy and indicates the basic information of the manufacturing site including name and address, dosage form, authorized activity and GMP standards of which the manufacturer complies with.
The fee is SGD$630 per manufacturing site per dosage form. There is no specific timeline involved as this is evaluated in conjunction with the submission of a product registration. Once the site is registered, there will not be a need to go through a similar conformity assessment for a similar dosage form.

 

2nd pathway Overseas On-site Audit 
Manufacturers would be subjected to this pathway due to the following conditions such as unavailability of acceptable GMP evidence, inadequate GMP evidence to demonstrate compliance, regulatory concern regarding GMP compliance of manufacture or product alert related to product defect or recall associated with the site concerned.
For this pathway, application would need to prepare a Quality System Dossier in accordance to Preparation of a Quality System Dossier (GUIDE-MQA-019) with a list of supporting documents to the authority for evaluation. Once the application is accepted for evaluation, an overseas inspection will take place based on the schedule of inspectors and availability of the manufacturing site that is to be audited.

 

The fees are presented below:
QSD evaluation- $4,770
On site audit located in ASEAN country- $18,400
On site audit located in ASEAN- $20,400
On-site audit located outside of Asia- $24,400

 

Post inspection, the authority will issue a letter to summarize the inspection including any potential observations or deficiencies that are required to be addressed. Applicant will be given about a month time to provide CAPA.
Upon successful close out of the post inspection findings, the applicant will be informed of the outcome.

 

We hope the above information is supportive for your product registration in Singapore If you need help to evaluate your GMP documents , please get in touch or if not feel free to share with your peers.

 

Useful references:
1. https://www.hsa.gov.sg/therapeutic-products/register/gmp-conformity-assessment
2. PIC/S Guide to GMP for Medicinal Products.