随着药物研发日益艰难、临床周期拉长、法规门槛不断抬高，越来越多的制药公司和新兴电商品牌开始将目光转向保健品和化妆品。与此同时，消费者对预防性健康、日常保健和功能性产品的关注度也在持续上升。多年前我们就看到“超级食品”和保健成分的兴起，但今天的市场竞争已远非当年可比。

随着竞争加剧，许多公司为了让产品脱颖而出，开始将配方和定位做得越来越像“药”。

这正是法规风险开始浮现的地方。

一、先搞清楚你在做什么产品

产品开发的第一步，是想清楚你究竟在创造一个什么类别的产品。简单来说：

保健品，是由维生素、矿物质、氨基酸、传统成分或植物提取物制成的产品，用于补充日常膳食、支持身体功能。

化妆品，是主要用于清洁、美化、赋香、保护或改善皮肤、头发或身体外观的产品。

这些定义看起来不难，但真正的法规风险，往往来自产品如何被配方、如何被定位、如何被推向市场。

二、三个核心：配方、标签、宣称

很多情况下，产品的法规风险并非来自某一个成分，而是来自产品的整体呈现。

1. 配方

在设计配方时，企业需要理解每个成分在生理上的作用，以及组合后的配方是否真正支撑产品的预期用途。我们看到越来越多的公司，将多种植物提取物、维生素、传统草药、功能性食品成分和新型原料体系，糅合成极其复杂的配方，试图让产品看起来更有“功效”。

在某些情况下，整体配方可能已悄然滑向边界地带，甚至趋近于治疗性定位。新型剂型和递送系统（如脂质体技术）也可能因产品定位和宣称的需要，面临额外的法规考量。

2. 产品标签与定位

产品标签，应当与产品类别和消费者对产品的认知保持一致。需要仔细考量的方面包括：产品的预期用途、使用说明、剂量建议、目标消费人群，以及整体的市场营销呈现。有些时候，即便配方本身没有明显问题，产品的整体呈现和营销方向，也可能开始制造出一种“药”的印象。

3. 宣称

这是产品审评中最常见的问题之一：宣称超出了产品应有的类别范围。例如：

• 化妆品宣称能舒缓湿疹或牛皮癣

• 护发精华或保健品声称能刺激头发再生、逆转脱发

• 含咖啡因或草本兴奋剂的能量补充剂，声称能治疗慢性疲劳或改善倦怠症状

• 保健品声称能逆转骨关节炎、自然控制糖尿病或预防心血管疾病

• 产品虽定位为化妆品或保健品，却暗示具有疾病预防、治疗效果或医疗成效

许多企业认为，增加更多的营销宣称，能让产品在商业上显得更强。但过度或缺乏支撑的宣称，反而可能引发更多的法规关注。更可持续的做法，是聚焦在少数几条有充分支撑的宣称上，以公认参考文献、已发表文献或成熟的成分数据作为依据。

三、我们经常看到的误区

最常见的误区之一，是以为在别的国家能被接受的产品，在新加坡的法规框架下就能自动放行。

事实未必如此。

例如，某些在海外作为保健品销售的新兴保健成分或产品类别——如含有SARMs的补充剂、定位为认知增强的新型蘑菇提取物、促睾补充剂、CBD类保健产品、肽类美容补充剂——在新加坡可能需要更审慎的法规评估，取决于成分特性、剂量强度、预期用途和产品宣称。

还有一些产品，标签上虽然没有直接提及疾病，但整体的广告和营销物料却在强烈暗示治疗意图。例如：

• 祛痘精华宣称“临床验证祛痘治疗”

• 护发产品声称能“刺激头发再生”

• 能量补充剂声称能“支持身体压力恢复”

• 保健品暗示能控制糖尿病、关节炎、激素失调或其他疾病

就在这个环节，企业在无意中将自己的产品推入了边界地带，触发了额外的法规审查或分类争议。

四、进入市场前，先问自己几个关键问题

在进口或上市之前，企业应当认真思考：

• 配方在逻辑上是否支撑产品的预期用途？

• 宣称是否适度，且有科学支撑？

• 产品的整体呈现，是否在向药品靠拢？

• 新型成分或技术，在目标产品类别中是否可被接受？

• 相比其他市场，新加坡的法规是否会以不同的方式解读这个产品？

及早评估这些方面，能帮你避免后期不必要的配方重做、营销修改和注册延误。

五、为什么法规定位要趁早？

很多公司直到产品配方、品牌和营销概念全部敲定，才开始考虑法规要求。

但到了这个阶段，如果产品定位已经过于趋近治疗性，往往需要大幅调整。这种情况在以下产品中尤为常见：主打强效定位的产品、运用新型原料技术的产品、高浓度植物复方产品，以及试图打造更具“临床效果感”的药妆概念产品。

在实操层面，法规评估不应只看某个成分是否“可以用”，更要看产品的整体呈现、配方逻辑和预期宣称，是否始终与产品类别保持一致。这也是为什么在批量生产、包装定稿和营销铺开之前，尽早展开法规策略讨论如此重要。

六、TRC如何提供支持

TRC为企业面向新加坡市场的保健品、化妆品及边界产品，提供早期法规评估服务。

支持范围包括：产品分类评估、配方与成分审阅、宣称与标签评估、边界风险识别，以及在进口或递交申请前，就市场定位给出合规指引。

很多情况下，一次早期的法规审阅，就足以在大量时间和资源被投入上市活动之前，识别出潜在问题。

如果你正在评估一款新的保健品、化妆品或功能性保健产品是否适合进入新加坡市场，欢迎联系TRC进行初步探讨。

With increasing challenges surrounding drug development, long clinical timelines and rising regulatory barriers, many pharmaceutical companies and emerging e-commerce brands are beginning to expand into health supplements and cosmetics.

At the same time, consumers are becoming increasingly focused on preventive health, wellness and functional products that support daily wellbeing. We started seeing this trend years ago with the rise of “superfoods” and wellness-focused ingredients, but the market today has become much more competitive.

As competition increases, many companies are now trying to formulate and position their products to look increasingly “drug-like” in order to stand out in the market.

This is where regulatory concerns may start to arise.

Understanding the Intended Product Category

One of the first steps during product development is understanding what type of product you are actually trying to create.

Simply:

Health Supplements

Health supplements are products made from vitamins, minerals, amino acids, traditional ingredients or botanical extracts intended to supplement the diet and support healthy body functions.

Cosmetics

Cosmetics are products intended primarily for cleansing, beautifying, perfuming, protecting or improving the appearance of the skin, hair or body.

While these definitions may appear straightforward, the actual regulatory concerns often arise from how the product is formulated, positioned and marketed.

The Three Core Areas: Formulation, Label and Claims

In many situations, the regulatory risk of a product does not come from a single ingredient alone, but from the overall presentation of the product.

1.Formulation

When designing a formulation, companies should understand how the individual ingredients work physiologically and whether the combined blend supports the intended purpose of the product.

We increasingly observe companies combining:

• multiple botanical extracts,
• vitamins,
• traditional herbal ingredients,
• functional food extracts,
• and novel ingredient systems

into highly complex blends designed to appear more “efficacious”.

In some situations, the overall formulation may begin moving closer towards a borderline or therapeutic positioning.

Novel dosage forms and delivery systems such as liposomal technologies may also require additional consideration depending on the product positioning and intended claims.

2.Product Label and Positioning

The product label should align with the intended product category and consumer understanding of the product.

Areas that should be considered include:

• intended purpose of the product,
• directions for use,
• dosage recommendations,
• target consumers,
• and overall marketing presentation.

In some situations, even where the formulation itself appears acceptable, the overall presentation and marketing direction may begin creating a therapeutic impression.

3. Claims

One of the most common issues observed during product review is the use of claims that extend beyond the intended product category.

Examples may include:

• cosmetics claiming to relieve eczema or psoriasis,
• hair serums or supplements claiming to stimulate hair regrowth or reverse hair loss,
• energy supplements containing caffeine or herbal stimulants claiming to treat chronic fatigue or improve burnout symptoms,
• supplements claiming to reverse osteoarthritis, control diabetes naturally, or prevent cardiovascular disease,
• or products implying disease prevention, therapeutic benefit, or medical treatment outcomes despite being positioned as cosmetics or health supplements.

In many situations, companies assume that adding more marketing claims makes the product appear stronger commercially. However, excessive or unsupported claims may instead increase regulatory concerns.

A more sustainable approach is to focus on a smaller number of well-supported claims supported by recognised references, published literature or established ingredient data.

Common Misconceptions We Commonly Observe

One of the more common misconceptions is assuming that a product accepted in another country will automatically be acceptable under Singapore’s regulatory framework.

This may not always be the case.

For example, certain novel wellness ingredients or emerging product categories marketed overseas — such as SARMs-containing supplements, novel mushroom extracts positioned for cognitive enhancement, testosterone-boosting supplements, CBD-type wellness products, or peptide-based beauty supplements — may require closer regulatory consideration in Singapore depending on:

• ingredient profile,
• dosage strength,
• intended purpose, and
• product claims.

Similarly, some products may technically avoid directly mentioning diseases on the label, while the overall advertising and marketing materials strongly imply therapeutic intent.

Examples may include:

• acne serums marketed as “clinically proven acne treatment”,
• hair products claiming to “stimulate hair regrowth”,
• energy supplements claiming to “support body stress recovery ”,
• or supplements implying management of diabetes, arthritis, hormonal imbalance, or other medical conditions.

This is where companies may unintentionally move their product into a borderline category and trigger additional regulatory scrutiny or classification concerns.

Key Questions to Consider Before Market Entry

Before importing or launching a product, companies should consider:

• Does the formulation logically support the intended product purpose?
• Are the claims proportionate and scientifically supportable?
• Does the overall product presentation resemble a therapeutic product?
• Are novel ingredients or technologies acceptable within the intended category?
• Could the product potentially be interpreted differently under Singapore regulations compared to other markets?

Early assessment of these areas can help reduce unnecessary reformulation work, marketing revisions and regulatory delays later in the process.

Why Early Regulatory Positioning Matters

In many situations, companies only begin considering regulatory requirements after the product formulation, branding and marketing concepts have already been finalized.

However, by that stage, significant changes may already be required if the product positioning begins leaning too closely towards therapeutic territory.

This is particularly common in products developed around:

• aggressive efficacy positioning,
• novel ingredient technologies,
• highly concentrated botanical blends,
• or “cosmeceutical”-style concepts designed to appear more clinically effective.

In practice, regulatory assessment should not only focus on whether an ingredient is “allowed” individually, but also whether the overall product presentation, formulation rationale and intended claims remain consistent with the intended product category.

This is one of the reasons why early regulatory strategy discussions are important before large-scale manufacturing, packaging finalisation or marketing rollout begins.

How TRC Can Support

TRC supports companies with early-stage regulatory assessment for health supplements, cosmetics and borderline products intended for the Singapore market.

Support may include:

• product classification assessment,
• formulation and ingredient review,
• claims and label evaluation,
• identification of borderline regulatory risks,
• and guidance on appropriate market positioning before importation or submission activities.

In many situations, an early regulatory review is often sufficient to identify potential issues before significant time and resources are invested into product launch activities.

If your company is currently evaluating a new supplement, cosmetic or functional wellness product for the Singapore market, feel free to contact TRC for an initial discussion.

Key Considerations

• Health supplements in Singapore are not subject to pre-market approval.
• The Voluntary Notification System (VNS) allows companies to submit product information on a voluntary basis.
• VNS does not constitute regulatory approval or endorsement.
• Companies remain fully responsible for ensuring compliance prior to market entry.
• In practice, VNS may be used as part of internal documentation or where requested by major pharmacy stores.

Health supplements in Singapore are not subject to pre-market approval. However, the Health Sciences Authority provides a Voluntary Notification System (VNS), which allows companies to submit product information on a voluntary basis.

While VNS is not a regulatory requirement, it may be used in practice as part of a company’s internal regulatory documentation or where requested by distributors and retailers prior to product onboarding.

1. Role of VNS in Supporting Regulatory Documentation

In practice, distributors and retailers may require evidence of regulatory assessment or supporting product documentation prior to onboarding.

While not mandated by the authority, participation in VNS may be used by companies as part of their documentation to facilitate such discussions.

2. Use of VNS in Market Access and Distribution

Participation in the Voluntary Notification System (VNS) may be considered as part of a company’s internal regulatory documentation approach.

In practice, distributors and retailers may request supporting product information prior to onboarding. This typically includes product composition, labelling and relevant compliance documentation.

Where applicable, VNS may be used as part of the overall documentation set to support such discussions. However, it should be noted that VNS itself does not replace the need for proper regulatory assessment prior to market entry.

3. Limitations of VNS from a Regulatory Perspective

While VNS allows companies to submit product information on a voluntary basis, it does not constitute regulatory approval or endorsement by the Health Sciences Authority.

Participation in VNS does not exempt companies from ensuring that their products comply with all applicable safety, quality and labelling requirements prior to market entry.

As such, reliance on VNS alone without a structured regulatory assessment may lead to gaps in compliance.

4. Avoiding Misinterpretation of VNS

A common misconception is that participation in VNS equates to regulatory clearance or facilitates automatic market access.

In practice, companies remain fully responsible for ensuring that their products meet prevailing regulatory requirements at the point of importation and sale.

Maintaining proper documentation and conducting a structured regulatory assessment upfront are key to avoiding potential compliance issues post-market.

5. Role of VNS in Overall Regulatory Approach

While VNS may be used as part of a company’s documentation process, it should be considered within the context of a broader regulatory strategy.

It is not a substitute for classification assessment, ingredient review, or evaluation of product claims.

A structured regulatory approach remains necessary to ensure that products are appropriately positioned and compliant with local requirements prior to market entry.

Practical Considerations Prior to Participation in VNS

Companies considering participation in VNS should ensure that:

• product classification has been appropriately determined
• supporting documentation (e.g. formulation, test reports, labelling) is available
• local representation is established where required

In practice, this is often undertaken as part of a broader regulatory assessment prior to market entry.

Secure Long-Term Success in the Wellness Sector

While VNS may be considered as part of a company’s regulatory approach, it should not be viewed as a substitute for a structured regulatory assessment.

TRC supports clients on an end-to-end basis, from initial regulatory evaluation through to market entry planning and compliance alignment, particularly for companies entering Singapore without an established local regulatory function.

Take the first step now. Contact us today.

Key Takeaways

• Singapore’s traditional Chinese medicine (TCM) market offers strong growth potential, but strict regulations make compliance essential.
• Proper classification of Chinese proprietary medicine determines the regulatory pathway.
• Appointing the right local agent directly impacts approval timelines and compliance.
• Labelling, safety checks, and accurate translations are critical to avoid costly setbacks.
• Post-market vigilance protects both brand reputation and consumer safety.

Singapore’s TCM Market: Opportunities with Compliance at the Core

Singapore’s TCM market continues to grow, driven by consumer trust in heritage remedies and the rising popularity of holistic health solutions. For Chinese companies, this creates a significant opportunity to expand into a stable, regulated market. However, strict oversight ensures that every Chinese proprietary medicine entering Singapore meets high standards of safety and quality. Non-compliance can result in shipment delays, rejections, or even seizures, making regulatory readiness a non-negotiable part of market entry.

For companies aiming to import traditional Chinese medicine successfully, a clear understanding of Singapore’s regulatory framework is essential.

1. Classification of TCM Products in Singapore

The first step in market entry is determining how your product is classified. Singapore recognises two primary categories:

• Chinese Proprietary Medicine (CPM): These are usually finished dosage forms like tablets, capsules, or liquids. They must contain active ingredients derived from Chinese medicinal materials and may carry certain approved medicinal claims.
• Health Supplements: These products are intended to supplement the diet without making medicinal or disease-related claims. They face different safety and labelling standards compared to CPMs.

Understanding this distinction is crucial, as it defines whether your TCM product requires registration, notification, or exemption. For example, a company that mistakenly classifies a Chinese herbal supplement as a CPM may submit the wrong set of documents, include unsupported medicinal claims, and face immediate rejection from HSA. This not only delays approval but also adds unnecessary costs to rework the entire submission.

2. Licensing Requirements and Local Representation

No foreign company can sell Chinese proprietary medicine in Singapore without a licensed local agent. This representative serves as your formal link with HSA and is responsible for submitting applications, maintaining records, and managing post-market surveillance.

The choice of agent directly affects your approval timeline. An inexperienced partner may slow things down with incomplete filings or poor communication. By contrast, an established regulatory affairs consultant ensures efficient submissions and consistent compliance, making your entry into Singapore’s market much smoother.

3. Labelling and Safety Requirements

Singapore enforces detailed rules to guarantee that consumers know exactly what they are buying. Labels must include:

• Product name and dosage form.
• Full ingredient list with quantities.
• Directions for use, storage instructions, and expiry date.
• Name and address of both the manufacturer and the local agent.

Safety is equally critical. According to official registration requirements, Chinese proprietary medicine must avoid banned substances, toxic herbs, and contaminants such as heavy metals. Even minor oversights can trigger recalls or withdrawals, damaging both consumer trust and corporate reputation.

4. Listing and Exemption Processes

CPMs undergo a listing process that differs depending on whether the product is locally manufactured or imported. For imported products, the documentary requirements are more extensive than those for local products. While the process is classified as a listing rather than full registration, it remains essential to demonstrate that the product meets quality and safety standards consistent with its claimed indications.

In other cases, exemptions apply to traditional medicinal materials (TMMs), such as raw herbs or substances in their natural state. These are not subject to pre-market approval or licensing by HSA. However, companies are still responsible for ensuring such products are safe, properly labelled, and free from banned substances

may apply if the product meets narrow traditional-use criteria, such as being prepared and sold in small quantities for use according to traditional practice. Even under exemption, companies remain responsible for ensuring the product is safe, properly labelled, and free from banned substances.

Choosing the right pathway is crucial here. Attempting notification for a higher-risk product, for instance, can result in rejection and force the importer to restart the process under the correct route.

5. Common Issues Faced by Chinese Companies

Despite preparation, many companies run into recurring challenges when importing TCM products into Singapore. Some of the most frequent include:

• Missing or inconsistent documentation
• Inclusion of unapproved or banned ingredients
• Translation mistakes in dossiers or labels, which can block notification or mislead consumers.

These issues not only delay approvals but may also damage a company’s credibility with regulators. They are avoidable with early regulatory gap assessments, the use of professional translation and formatting services, and by engaging consultants with local market experience. Proactive preparation ensures smoother communication with HSA, faster approvals, and significantly reduces the risk of costly rework.

6. Post-Market Compliance

Compliance does not end once a product is launched. Companies must continue to:

• Monitor safety and report adverse events.
• Conduct periodic testing and maintain updated records.
• Stay inspection-ready at all times.

Ongoing vigilance ensures that every Chinese proprietary medicine remains compliant and safe for consumers. This commitment not only satisfies regulators but also strengthens your brand’s credibility in a competitive market.

Partnering for Safe and Successful Market Entry

Singapore offers Chinese companies significant growth opportunities in the TCM sector. But success requires not just product quality but also meticulous attention to regulatory details, from correct classification and licensing to post-market vigilance. 

By working with The Reg Consultants, you gain a trusted partner that specialises in guiding companies through the complexities of HSA registration and regulatory support in Singapore. Whether you are introducing a pharmaceutical product, CPM, or health supplements, our team ensures your entry into the local market is compliant, safe, and built for success.

Speak with our team of specialists today.

Navigating Special Purpose Food Registration in Singapore

Special purpose food plays a vital role in catering to individuals with unique dietary needs. According to the Food Regulations, Section 247 Clause, special purpose food is defined as food named or described as particularly suitable for consumption by persons belonging to a specific class who require a special diet. These foods are composed of modified, prepared, or compounded substances that possess nutritive and assimilative properties, making them suitable for individuals requiring specialized diets.

Examples of special purpose food include:

• Diabetic food
• Food containing added phytosterols, phytosterol esters, phytostanols, or phytostanol esters
• Low sodium food
• Gluten-free food
• Low protein food
• Carbohydrate-modified food
• Low calorie food
• Energy food
• Infant formula food
• Formulated food

Additionally, these products may contain vitamins, minerals, amino acids, and other nutrient supplements to support dietary requirements.

Steps to Import Special Purpose Food into Singapore

If you are planning to import special purpose food into Singapore, here are the essential steps to follow:

1. Classify Your Product
   • Determine if your product falls under the food category or another regulated category.
   • Key considerations:
     • Is the product consumed as part of a daily diet or as a dietary supplement?
     • Does it have defined dosage instructions and usage restrictions?
     • Does it come in conventional food forms such as beverages or powders?

   You can refer to the SFA’s Food Classification Guidelines for more information.

2. Check Registration and Licensing Requirements
   • Processed food typically requires product registration.
   • Certain controlled food items, including meats, seafood, eggs, fresh fruits, and vegetables, may require additional licenses.

   More information on registration requirements can be found on the SFA Food Import and Export page.

3. Verify Product Composition
   • Ensure the product formula only contains permitted colorings, food additives, vitamins, minerals, and amino acids as per Singapore’s Food Regulations.
4. Comply with Labelling Requirements
   • The product must include a Nutrition Information Panel in the format specified under the Twelfth Schedule of the Food Regulations.
   • Labelling should indicate the specific dietary purpose and comply with all regulatory requirements.
5. Substantiate Product Claims
   • Product claims must be truthful and not misleading.
   • Avoid statements implying treatment, cure, or prevention of diseases.
   • The product should not claim to replace a specific diet unless backed by scientific evidence.
6. Register Your Product
   • Submit the registration to import processed food products and appliances  to SFA.
   • Activate a Customs account to facilitate importation. Visit the TradeNet System for Customs account registration.
7. Apply for Import Permits
   • Each consignment of special purpose food requires an import permit for customs clearance. This can be applied through the TradeNet System.
8. Customs Clearance and Distribution
   • Once the cargo permit is approved, the consignment can be cleared for customs and distributed locally.

Common Challenges Faced by Importers

Navigating the regulatory landscape can be overwhelming, especially for companies unfamiliar with Singapore’s stringent food regulations. Common challenges include:

• Uncertainty in product classification
• Compliance with labelling and nutrient content requirements
• Delays in product registration
• Rejections due to insufficient documentation

How The Reg Consultants Can Support You

The regulatory landscape for special purpose food can be complex and challenging to navigate. At The Reg Consultants, we provide comprehensive support to help you evaluate your special purpose food products and ensure compliance with Singapore’s regulations.

Our services include:

• Product classification assessment
• Regulatory gap analysis
• Labelling review
• Registration 
• Import permit application

With our expertise in regulatory affairs, we streamline the registration process and help you bring your special purpose food products to the Singapore market efficiently.

Get in Touch with Us Today

Let us take the complexity out of the regulatory process while you focus on growing your business. Contact The Reg Consultants today for personalized guidance and expert support on registering your special purpose food products.

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!
You may want to check out other articles which might be relevant for your planning:

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 today’s fast-paced society, maintaining a healthy diet has never been more relevant. Nutraceuticals, or health supplements, are becoming increasingly popular for their role in maintaining overall health and supplementing nutrients lacking in our daily diets. These products are typically derived from natural and organic sources, catering to growing interests in areas such as immunity, joint support, sports nutrition, and heart health. Additionally, immunity boosters, cholesterol-lowering agents, fish oil, skin and hair-strengthening supplements, collagen supplements and fat-burning supplements are some of the highest-selling products in the market. 

Yet, the absence of unified regulations in certain aspects, such as labelling, might complicate product marketing across ASEAN countries and limit consumer access. In this article, we will delve into the complexities of complying with multiple local protocols while highlighting the importance of product safety and market entry.

• Harmonised Standards

In 2004, the ASEAN Economic Community established the Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) to unify technical requirements for nutraceutical or health supplements and traditional medicines across the region. The group developed ten core annexes or technical requirements essential to harmonisation efforts. However, these have yet to be fully implemented as they require the ratification document to be signed by ASEAN trade ministers.

ASEAN Harmonised Technical Guidelines and Standards for Health Supplements

• Annex I– ASEAN Guiding Principles for Inclusion Into or Exclusion From the Negative List of Substances for Health Supplements
• Annex II– ASEAN Guiding Principles for the Use of Additives and Excipients in Health Supplements
• Annex III – ASEAN Guidelines on Limits of Contaminants for Health Supplements
• Annex IV – ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Health Supplements
• Annex V – ASEAN Guidelines on Stability and Shelf-Life of Health Supplements
• Annex VI – ASEAN Guiding Principles on Safety Substantiation of Health Supplements
• Annex VII – ASEAN Guidelines on Claims and Claims Substantiation for Health Supplements
• Annex VIII – ASEAN Guideline on Good Manufacturing Practice for Health Supplements
• Annex IX – ASEAN Guidelines on Labelling Requirements for Health Supplements
• Annex X – ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements

Despite this, countries like Singapore, Malaysia, Brunei, Thailand, and Myanmar have begun adopting these standards, especially for the inclusion or exclusion of substances on the negative list. Though yet to be ratified, they provide a uniform framework, simplifying approvals and facilitating market entry. Adherence ensures products meet safety and quality criteria, which is crucial for consumer confidence and market success.

• Registration Process

Registering a nutraceutical product in the ASEAN region usually involves several steps, which can vary slightly from country to country. Typically, this includes submitting detailed product information, safety data, and efficacy studies to the relevant regulatory authority. Despite these variations, all countries stress the importance of thorough documentation and adherence to local regulations. Understanding these steps enables companies to plan effectively and prevent delays in the registration of pharmaceutical products and dietary supplements.

• Labelling Requirements

Among the many regulations to follow, labelling stands out as one of the most crucial aspects. Mandatory information often includes the product name, the name and strength of the active ingredients, usage instructions, and any necessary warnings. Labels must be clear, accurate, and in the appropriate languages used in the countries where the product will be sold. Adhering to these guidelines when introducing nutraceuticals into the ASEAN region makes sure that consumers receive the necessary information for safe and effective product use.

For detailed labelling requirements, refer to the ASEAN guidelines on labelling requirements.

• Permissible Ingredients

Furthermore, each ASEAN country maintains a list of approved ingredients for nutraceutical products, aligned with ASEAN guidelines that determine which substances are permitted or restricted. These lists often impose restrictions on certain substances for safety and efficacy reasons. Companies must stay informed about these lists and verify that their products comply with regulatory standards by avoiding prohibited ingredients. This vigilance not only helps minimise regulatory risks but also certifies that the products are safe for consumers.

Read more: ASEAN Guiding Principles for Inclusion Into or Exclusion from the Negative List of Substances for Health Supplements.

• Market Access Challenges

Gaining market access in the ASEAN region involves navigating diverse regulatory requirements and addressing local market conditions, which can pose significant challenges. Companies often encounter hurdles such as varying approval timelines, different documentation requirements, and cultural nuances affecting product acceptance. Overcoming these challenges requires strategic approaches such as conducting thorough market research, collaborating with local regulatory specialists, and remaining flexible to adapt to evolving procedures and market dynamics.

Navigating nutraceutical regulations in the ASEAN region requires a thorough understanding of the factors listed above. With the right insights and the support of regulatory affairs services, you can ensure compliance and successfully enter the ASEAN market. If you need guidance, consider reaching out to The Reg Consultants in Singapore. Our team offers comprehensive services to help you achieve regulatory compliance.

Contact us today to explore how we can support your market entry into the ASEAN region.

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!

Chinese Proprietary Medicines(中成药产品)  refers to finished medicinal  product, such as a capsule or tablet, and contains one or more active ingredients from any plant, animal or mineral, or any combination of sources. All the active ingredients must be documented for use in traditional Chinese medicine.

Prior to importation and distribution of CPM in Singapore, CPM must undergo a product listing approval process.

A brief outline of the registration requirements, processing timeline and fees are presented below:

How Singapore Oversees the Listing of Chinese Proprietary Medicine Products

1. Labels of product to be sold including including inner label, outer carton and package insert
2. Photograph of the product’s contents.
3. Labels of product sold/supplied in country of manufacture including inner label, outer carton and package insert
4. Manufacturer’s Licence or certificate
5. Good Manufacturing Practice (GMP) certificate if any
6. Product registration certificate (if applicable)
7. Free sale certificate of equivalent from country of manufacture
8. Test results of toxic heavy metals and microbial contamination
9. Storage condition/containers
10. Quality parameters for CPM products
11. Endorsement of product formula (including all active and inactive ingredients) by overseas manufacturer and undertaking by overseas manufacturer that product does not contain any Western drugs or active synthetic substance
12. Information on legal classifications of product in countries of sales
13. Website undertaking – for products with website stated on label(s)
14. TSE undertaking – for products containing materials (including those used for making capsule shells) derived from ruminants (e.g. cattle, buffalo, sheep, goat, deer, antelope)
15. Info for Fermented Substance – for products containing fermented substance(s) (e.g. Cordyceps, Red Yeast Rice)

 

Processing timeline and fees

The listing  process takes about 60 working days and there are no fees associated with listing.

Pre-Submission Compliance Review for CPM Products

1. Ensure that the CPM does not contain any substances from the Poison Act and its schedule.
2. If the CPM contains substances listed under the Endangered Species (Import & Export) Act, dealers should contact the Wildlife Management Group of the NParks to obtain the necessary Convention on the International Trade in Endangered Species of Wild Fauna and Flora (CITES) import and export permits.
3. The labels cannot reference to certain diseases or conditions such as : blindness, cancer, cataract, drug addiction, deafness, diabetes, epilepsy , hypertension, insanity, kidney disease, leprosy, menstrual disorders, paralysis, tuberculosis, sexual function, infertility, impotency , frigidity, conception, and pregnancy.
4. Test report:

• The date of analysis stated on the test report must be within 2 years from the date of evaluation on the CPM product listing.
• The product’s batch number must be stated on the test report, and it must be in accordance with the batch numbering system declared in the online application form.
• If the test result is “not detected/ND”, the limit of detection must be stated on the test report
• The test result cannot be stated as “less than legal limit”

5. Quality parameters for CPM should include

• Storage condition
• Physical characteristics of the product such as colour, taste, smell, shape, size of capsule, and can be included in the product’s Certificate of Analysis (COA) or as a separate document.
• Physical specifications as per dosage form

6. Note that physical samples of the product and testing might be required by the authority upon request. Testing should be conducted based on laboratories with accredited methods.

 

Useful References for Importers of CPM Products

Guidelines on CPM Product Listing  English version and Chinese version

Feel free to share this with your peers who has plans to import Traditional Chinese medicine in Singapore or contact us if you need local expertise to support your listing process.