Key Takeaways
- Module 3 of the Common Technical Document (CTD) tends to be the most scrutinised section in a biologics licence application.
- Incomplete chemistry, manufacturing, and controls (CMC) data, inconsistent speculations, and a lack of scientific justifications are the top reasons behind queries from Health Sciences Authority (HSA).
- Working with an experienced regulatory affairs consultant can help ensure Module 3 is complete, consistent, and fully aligned with HSA expectations.
Module 3: A Common Roadblock in Biologics Submissions
In biologics licence applications, Module 3 of the CTD is a critical component. It addresses CMC and ensures biologics are consistently produced to meet stringent quality, safety, and efficacy standards. For submissions made by brands or regulatory representatives in Singapore, the HSA pays particular attention to this module, and errors can result in prolonged queries or outright rejections.
Given the complexity of biologics, regional regulatory differences, and the need for robust data packages, working closely with a regulatory affairs consultant from the early stages can streamline compilation and prevent late-stage surprises.
Module 3 (CMC) data needs to demonstrate that the biologic is consistently manufactured, controlled, and characterised to meet quality, safety, and efficacy standards. Regulatory authorities like HSA, EMA, and FDA expect comprehensive, well-justified data covering:
- Drug substance characterisation: Physicochemical properties, biological activity, glycosylation profiles, impurities, and batch consistency (ICH Q5A/B/C, FDA CMC Guidance).
- Drug product controls: Formulation, container closure systems, in-process controls, and batch-to-batch consistency.
- Stability programs: Real-time and accelerated studies demonstrating product quality across shelf-life.
- Analytical methods and validation: Accurate, precise, and suitable for intended use.
Failing to meet these expectations can trigger major HSA queries, which often mirror FDA/EMA review concerns, including incomplete justification for specifications or missing comparability data.
1. Incomplete CMC Information
Incomplete CMC data is one of the top causes of major HSA queries. This may include:
- Missing process flow diagrams or incomplete control strategy descriptions
- Fragmented batch analysis data or inconsistent release specifications
- Lack of raw material characterisation for critical components
Mitigation strategy:
- Integrate multi-site manufacturing data early and reconcile inconsistencies
- Map critical quality attributes (CQAs) to control strategies (per ICH Q8/Q9/Q10)
- Conduct internal pre-submission audits to identify gaps before HSA review
To avoid this, implement a Module 3-specific checklist and involve CMC, quality assurance (QA), and regulatory teams early in the development process. Tracking data readiness from the outset ensures that your biologics licence application progresses smoothly without unexpected information gaps.
2. Cross-Section Inconsistencies
Inconsistent data is a common source of concern for HSA reviewers and can quickly undermine the integrity of a submission. Examples include:
- Mismatched drug substance and drug product specifications
- Contradictory analytical results
- Mislabelled manufacturing sites
Such discrepancies erode credibility, trigger major queries, and can lead to significant delays in approval. To mitigate these risks, companies and marketing authorisation holders should:
- Implement cross-functional verification and formal data reconciliation before submission
- Maintain version-controlled master documents to ensure accuracy across all sections
- Work closely with an in-country regulatory rep or a regulatory affairs (RA) consultant for product approval in Singapore. This ensures rigorous cross-checking and alignment.
This ensures rigorous cross-checking, alignment with HSA requirements, and fewer post-submission queries
3. Failure to Justify Specifications
Regulators expect every specification in Module 3 to be backed by a clear scientific rationale, as outlined in ICH Q6B. However, many submissions fail to meet this requirement by presenting specifications without linking them to reference standards, stability data, or risk-based controls.
To address this, companies should:
- Reference recognised pharmacopeial standards where applicable
- Connect specifications to manufacturing controls and stability study outcomes
- Document the rationale in a structured justification report to demonstrate compliance and data integrity.
Providing this level of scientific justification ensures that your biological licence application proceeds smoothly and shows reviewers that your company takes quality seriously. By partnering with The Reg Consultants (TRC), an experienced provider of pharma regulatory services, you gain the expertise and guidance needed to meet expectations with confidence.
4. Non-Compliant Stability Data
For biologics, HSA reviewers expect a robust stability package, including:
Multiple timepoints, stress conditions, and representative batches
Comparability studies after manufacturing changes, site transfers, or scale-up
Demonstrated link between stability data and shelf-life claims
These gaps increase the likelihood of HSA queries and delays. To mitigate risks, stability programmes should be designed from the outset with both ICH and ASEAN frameworks in mind, supported by validated analytical methods. Submissions must also include both real-time and accelerated data to provide a complete and compliant evidence package.
5. Poor Quality Translation and Formatting
Even when the underlying science is sound, poor presentation can compromise the credibility of a submission. Reviewers frequently encounter issues such as:
- Sloppy translations
- Missing headers
- Inconsistent numbering
- Misaligned tables
- Incomplete legends
These shortcomings can frustrate HSA reviewers and extend the timelines for your biologics licence application. To avoid such setbacks, companies should engage professional regulatory translators, adopt CTD-compliant templates, and conduct thorough quality control reviews before submission. Attention to detail in presentation not only reflects data integrity but also reinforces overall professionalism.
Strengthen Your Module 3 with Expert Support
Module 3 remains one of the most critical components of a biologics licence application, and it is also where many submissions face avoidable delays. By addressing critical gaps and ensuring internal consistency, companies can significantly reduce the risk of major queries.
At The Reg Consultants (TRC), we act as your regulatory affairs consultant and provide comprehensive HSA registration and regulatory support in Singapore, ensuring your Module 3 is accurate, complete, and inspection-ready. Our team facilitates smooth communication with HSA, enabling quicker resolution of queries and faster time to approval.
Connect with The Reg Consultants today to strengthen your Module 3 and improve your submission success rate.
We’re back for our weekly deep dive into the fascinating world of regulatory affairs! This week, I want to tackle a topic that comes up surprisingly often in my conversations with clients, especially those looking to bring life-saving products like vaccines to new markets: How do you leverage a WHO Prequalified (PQ) dossier for registration in Singapore?
Many assume a WHO PQ means a straight shot, but as we as seasoned regulatory people know, it’s rarely that simple. While WHO Prequalification is an incredible achievement and a powerful foundation, there are always those crucial local nuances that need expert navigation.
What Exactly is a WHO Prequalified Dossier?
The World Health Organization (WHO) Prequalification program is a global initiative designed to ensure that key health products meet international standards of quality, safety, and efficacy. Think of it as a stamp of global assurance. WHO conducts a rigorous assessment, scrutinizing everything from the product’s quality data to the manufacturing site’s Good Manufacturing Practice (GMP) compliance. It’s a comprehensive review aimed at facilitating access to essential, quality-assured medical products, particularly for procurement by UN agencies and other international bodies.
What Kinds of Products Fall Under WHO PQ?
Initially, the program focused heavily on medicines for HIV/AIDS, TB, and malaria. Over time, it has expanded significantly. Today, WHO Prequalification covers a broad spectrum of products vital for global health, including:
- Medicines (Finished Pharmaceutical Products and Active Pharmaceutical Ingredients): Especially generics and essential medicines.
- Vaccines: This is a huge one! Ensuring vaccine quality and efficacy for global immunization programs is a cornerstone of WHO PQ.
- In Vitro Diagnostics (IVDs): Products used for detecting diseases.
- Immunization Devices: Like syringes and safety boxes.
- Vector Control Products: Tools to fight vector-borne diseases.
Based on experiences and inquiries, vaccines are often the first product that comes to mind when leveraging WHO PQ. The principles, however, apply broadly across these categories.
Advantages of a WHO PQ Dossier
The advantages are:
- A Global Seal of Quality: A WHO PQ product has already undergone a thorough evaluation by a globally respected authority. This immediately instills confidence in national regulatory agencies (NRAs) about the product’s quality, safety, and efficacy profile.
- Streamlined Initial Review: For many NRAs, especially those with limited resources, a WHO PQ can significantly streamline their initial assessment, as much of the heavy lifting on the core scientific data has already been done.
- Market Access and Procurement: For many manufacturers, WHO PQ is a prerequisite for supplying products to major international procurement bodies, opening up vast markets.
- Robust Scientific and Quality Foundation: The WHO Prequalified dossier provides a comprehensive, pre-vetted scientific and quality package (often in CTD format). This means the core technical data, which is typically the most time-consuming to generate and compile, is largely established, significantly reducing the burden of its “major overhaul” when preparing for national submissions.
Bridging the Gap for Singapore Submission
Here are the key gaps we typically need to bridge:
- Local Administrative & Legal Requirements (Module 1): The WHO PQ dossier, while often following the CTD structure, will have a WHO-specific Module 1. HSA, like any national authority, has its own unique Module 1 requirements. This includes specific application forms, declarations, appointment of a local company/agent (which, surprise, surprise, is a must!), and adherence to local legal frameworks.
- Singapore-Specific Labelling & Package Inserts: Even if the core data is accepted, the product information (labels, package inserts, patient information leaflets) must be fully compliant with HSA’s detailed requirements for language, content, and format. This isn’t just a translation job; it’s a regulatory art form!
- Good Manufacturing Practice (GMP) Conformity: While WHO conducts GMP inspections for PQ, HSA recognizes PIC/S GMP as the standard. Based on recognition agreements and internal evaluation, manufacturing sites can either be subjected to a GMP DEVA assessment or an overseas inspection.
- Risk Management Plan (RMP): HSA requires a comprehensive Risk Management Plan, along with a Singapore-Specific Annex (SSA), to be submitted as part of the registration application for therapeutic products, including vaccines.
- Vaccine-Specific Lot Release: This is a crucial point for vaccines! Even after registration, all imported registered vaccines require a notification to HSA on lot release information before they can be supplied in Singapore. This is a critical post-registration compliance step.
- Dossier Format Alignment (ICH CTD/ACTD): While WHO PQ is increasingly aligned with CTD, HSA accepts both ICH CTD and ASEAN Common Technical Dossier (ACTD) formats. There can be subtle but important differences in how information is presented or what specific details are required within certain sections, especially if the ACTD format is chosen or if there are specific HSA guidance documents that refine the CTD expectations.
Essentially, a WHO PQ dossier gives you a solid scientific and quality foundation in which “a major overhaul” is essentially avoided when preparing for local submission.
How TRC Can Support Your Journey
TRC specializes in taking WHO Prequalified dossier and meticulously transforming it into a complete, compliant submission for HSA.
We don’t just translate documents; we understand the intent behind HSA’s guidelines and the specific nuances of what they’re looking for. From managing the intricate Module 1 administrative requirements, ensuring all labelling is compliant, to advising on GMP assessments and navigating the vaccine-specific lot release process – we cover all the bases.
Our “on-the-ground” practical experience in Singapore regulatory affairs means we can foresee potential roadblocks and proactively address them, streamlining your path to market. We work like an extension of your own team, guiding you through every step, ensuring that your life-saving vaccines, or any other WHO Prequalified product, reach the patients who need them, right here in Singapore.
Ready to make your WHO PQ a launchpad for Singapore market access? Let’s talk!
Amongst the ever-emerging trend of new generation drugs, there is a group that is not widely discussed yet still remains the gold standard of treatment — or even serves as the pharmacophore on which many modern drugs are built. Examples of grandfather products include aspirin, morphine, diphenhydramine, and propranolol — all introduced decades ago and still widely used today. Their pharmacophore structures have inspired the development of many modern drugs, demonstrating the enduring value of these legacy products. This term is exchanged quite regularly during conversations here and there but is often neglected when strategizing market entry. Today, we are here to touch on this group of special products.
What are Grandfather or Legacy Products?
In regulatory terms, grandfather products (also called legacy products) refer to products that were introduced to the market before modern regulatory frameworks were established. For chemical entity drugs, this usually means they were first approved decades ago under older requirements and have remained on the market with minimal updates to their dossiers.
Where do grandfather products often originate from?
Most grandfather or legacy products originate from established pharmaceutical markets such as the United States, Europe, and Japan, where products were approved under national regulations before harmonized ICH guidelines existed. Additionally, some products from regional manufacturers in ASEAN or other Asia-Pacific countries also fall into this category if they were registered locally before CTD implementation.
Such products may:
- Lack comprehensive ICH CTD-format dossiers, making it difficult to directly submit to regulatory authorities that require standardised formats
- Be registered under older country-specific formats with missing modules (e.g. no full Module 3 CMC data and incomplete Module 5 clinical data), resulting in significant rework before submission
- Have undergone manufacturing or formulation changes over time not fully captured in the current registration file, raising concerns on data consistency, bridging justifications, and regulatory acceptability
Common Issues with Legacy Product Dossiers
From my experience, clients often face these challenges with grandfather chemical entity products:
- Missing Module 3 data :Older products may only have a brief manufacturing summary without detailed process validation, impurity profiles, or stability data as per current ICH/ASEAN requirements. This leads to delays in submission preparation as sourcing and compiling such data can take months or require additional manufacturer support.
- Non-compliance with current guidelines:
Specifications, analytical methods, and validation reports may not align with updated pharmacopeial or ICH standards. This could result in deficiency queries or rejection if no bridging justification is provided. – Specifications, analytical methods, and validation reports may not align with updated pharmacopeia or ICH standards.
- Outdated safety or clinical information : For most well-established grandfather products, additional clinical data is generally not required if the product retains its original formulation, indication, and dosage form, and has a long history of safe use. However, dossiers may still lack current risk management plans or pharmacovigilance documentation, which are standard expectations under modern regulatory frameworks. In some cases, if a product is being introduced in a new dosage form or combined with a novel formulation, regulators may request bridging data or justification to confirm its safety and efficacy in the proposed context.
How TRC Can Help
At TRC, we support clients to resolve these gaps for market entry or re-registration in Singapore. Here are realistic examples of solutions we have provided:
Case 1: CMC Gap Analysis and Strategic Planning
A client approached us to register a 1980s-origin chemical entity analgesic in Singapore. The original dossier had:
Our approach:
- Conducted a Module 3 gap analysis against HSA’s current requirements
- Identified critical missing data and advised on the feasibility of sourcing them from the manufacturer or via new testing
- Developed a regulatory strategy to allow the client to decide whether to proceed with registration or prioritise alternative products in their portfolio
Case 2: Regulatory Intelligence Assessment for antibiotic
A Southeast Asian client aimed to bring in a legacy antibiotic product registered regionally before ASEAN CTD implementation.
Our approach:
- Conducted a regulatory intelligence assessment to clarify HSA expectations for legacy products
- Identified potential data requirements (e.g. stability data under ASEAN climatic zone IVb conditions, updated impurity profile data)
- Prepared a clear requirements list for the client to initiate discussions with their manufacturer efficiently and to plan next steps for dossier preparation
Case 3: Specification and Analytical Review Support for CNS Product
A European manufacturer sought to register a CNS (central nervous system) drug but its finished product specifications were outdated.
- Reviewed the current USP/EP standards for the active ingredient and finished product
- Provided recommendations to align the specifications with current standards to mitigate the risk of questions being raised during screening and evaluation
- Guided the client in preparing bridging justification documents to support acceptance of older analytical methods with supplementary validation where needed
Legacy or grandfather products hold strong market value, but their outdated dossiers often pose barriers to registration under modern frameworks.
Performing a regulatory intelligence exercise early — to understand current requirements and feasible pathways — is critical. Starting a gap analysis as the first step ensures that data gaps can be proactively addressed, reducing time to market entry.
At TRC, we specialise in guiding clients through these complexities to achieve successful registration outcomes in Singapore. Contact us if you need support in revitalising your legacy products for new market opportunities.
1. Drug Substance: More Than Just Chemistry (Module 3.2.S)
Biologics are made using living systems, which means the drug substance section (Module 3.2.S) is much more complex than in small molecule applications. HSA expects:
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Detailed information on cell bank systems, including Master and Working Cell Banks (MCB/WCB)
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Description of the expression system and host cell line
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Clear flowcharts of the manufacturing process with critical control points identified
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Robust validation of viral clearance steps
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Risk assessment of raw materials, especially if animal- or human-derived
A well-structured CMC package here is essential for a smooth review.
2. Comparability and Characterisation: Not Optional
One of the most common causes of regulatory delays in biologics submissions is insufficient comparability data. This applies to both innovator biologics (post-change) and biosimilars.
HSA will look closely at:
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Physicochemical characterisation: including glycosylation profiles, size variants, aggregates
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Biological activity assays: to demonstrate that the biosimilar or updated product maintains expected functionality
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Comparative studies across Modules 3, 4, and 5 — not just one section in isolation
If you’re referencing a non-local comparator product, a strong scientific and regulatory justification is critical.
3.Stability Studies: Real-Time, Real-World
Biologics are temperature-sensitive and prone to degradation, making stability studies a critical part of the dossier. Although biologics are excluded from the ASEAN Stability Guidelines and not required to be tested under Zone IVb conditions (30°C/75% RH), HSA still expects robust stability data under ICH-recommended conditions.
For Module 3.2.P.8, HSA typically expects:
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Real-time, real-temperature stability data under the proposed storage conditions (e.g., 2–8°C), using ICH Q5C guidance as reference
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Data from multiple commercial-scale batches to support consistency in shelf-life across manufacturing lots
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Shipping validation studies, including stress testing or temperature excursion data, to ensure product integrity during transport
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A well-justified shelf-life, based on real-time data, not solely on extrapolation from accelerated studies
Even though Zone IVb is not applicable to biologics, your stability strategy must still demonstrate that the product remains safe, pure, and potent throughout its lifecycle — including under real-world transport and storage conditions.
Incomplete stability data is one of the most common flags at the screening stage.
4.Clinical and Nonclinical Data: Focus on Immunogenicity
In Modules 4 and 5, HSA’s review focuses on whether the clinical and nonclinical data:
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Clearly support the biologic’s safety, efficacy, and immunogenicity profile
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Include bridging data or scientific justification if the biosimilar comparator is not registered in Singapore
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Are derived from ICH-compliant studies, even if conducted overseas, as local Singapore data is not required by default
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Include robust immunogenicity assessments, especially for biologics intended for chronic use or repeated dosing
While HSA does not require studies in Singaporean patients, it expects that the clinical data be applicable to the intended population, and any major differences in demographics or clinical practice should be addressed through scientific justification.
Even for rare diseases or products supported by limited clinical data, a well-reasoned explanation is still expected.
5. Quality Overall Summary (QOS): More Than a Summary
The QOS (Module 2.3) in Singapore plays a central role in the reviewer’s assessment. It’s not just a summary — it’s a narrative of your product’s journey, from manufacturing to safety to clinical utility.
A good QOS should:
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Clearly connect CMC, nonclinical, and clinical data
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Provide justifications for control strategies and batch selection
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Reference tables and annexes logically
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Be tailored to HSA’s review style — concise, structured, and scientific
Cut-and-paste summaries from EU or US applications often don’t work well in Singapore.
6.Regulatory Strategy: Think Local Early
While HSA accepts ICH-aligned submissions, it expects sponsors to demonstrate a clear understanding of the local regulatory context.
Key points to consider:
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Reference product: If a biosimilar comparator is not registered in Singapore, provide bridging data or a scientific justification referencing global approvals and literature
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Post-approval commitments: Be prepared for ongoing requirements, such as continued stability studies or local pharmacovigilance plans, especially for newly marketed biologics
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Clear comparability strategy: HSA places importance on how changes to manufacturing or biosimilarity are justified. Submissions should include a transparent, risk-based comparability plan that aligns with ICH Q5E principles
Even for biologics already approved by major agencies (e.g., FDA, EMA), you may need to bridge data or adapt your justifications to address specific HSA queries or the Singapore healthcare context.
7. Common Pitfalls to Avoid
Based on experience supporting biologics submissions in Singapore, here are common areas that often lead to screening queries or delays during HSA review:
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Quality Overall Summary (QOS) not clearly presenting key quality attributes or addressing issues HSA typically prioritizes (e.g., comparability, control strategy, or stability justification)
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Comparability data that is insufficient, unclear, or does not adequately support product consistency or biosimilarity
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Stability protocols that overlook ICH Q5C guidance or fail to provide adequate real-time, real-temperature data — biologics are not subject to ASEAN Zone IVb requirements, but must still demonstrate product integrity
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Reference product justification missing or weak for biosimilars, especially if the comparator is not registered in Singapore
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Analytical method validation or bridging justifications not sufficiently detailed in Module 3, particularly when methods are adapted across sites or jurisdictions
Addressing these areas early can help reduce avoidable screening issues and improve overall dossier quality.
Starting with a gap analysis is highly recommended if you’re adapting a dossier from another region.
How TRC Can Support You
At TRC, we help companies prepare and localise their biologics submissions for the Singapore market. Our services include:
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CTD format and content gap analysis tailored to HSA expectations
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Submission preparation and planning, including guidance on required documents and formatting
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Support with regulatory strategy, such as identifying reference product considerations or bridging needs
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End-to-end coordination through the evaluation process, including screening query management and communication with HSA
We work closely with clients and their technical teams to ensure submissions are well-aligned with Singapore’s regulatory requirements — without duplicating scientific or manufacturing work already in place.
Biologics are powerful therapies, but the regulatory path in Singapore is not straightforward. Each module of the CTD needs careful attention — not just to meet international standards, but to reflect what HSA expects locally.
Whether you’re a small biotech or an established pharma company, having a clear local regulatory strategy can significantly shorten your path to approval.
Feel free to reach out if you’d like to discuss your biologics submission plans. We are happy to support.
Disclaimer: This blog is written based on the author’s current understanding, regulatory experience, and publicly available information. It is intended for general informational purposes only and does not constitute regulatory advice. For official requirements, please refer to the latest guidelines issued by the Health Sciences Authority (HSA) .
In recent times, we’ve received numerous inquiries about the possibility of rebranding complementary health and cosmetic products in Singapore, particularly due to geopolitical factors. Many companies are looking to facilitate export to their home countries, and understanding how to rebrand products as “Made in Singapore” can be a strategic advantage. In this article, we’ll explore what constitutes a product as “Made in Singapore,” the pathway to achieve this , and the certifications available from Singapore Customs , Singapore Manufacturing Federation, as well as the Singapore International Chamber of Commerce, that can facilitate export.
What is Considered a “Made in Singapore” Product?
A “Made in Singapore” product refers to goods that are substantially manufactured or processed within Singapore, in line with regulatory criteria established by local authorities. To earn this designation, a significant portion of the production costs—including labor and materials—must be incurred locally, ensuring considerable local value addition. Furthermore, products must comply with Singapore’s safety, health, and environmental standards to meet quality expectations.
It’s essential to note that if a product is manufactured outside of Singapore and only undergoes labeling or assembly here, it may be labeled as “Packed in Singapore” or “Secondary assembled by ABC Pte Ltd in Singapore.” However, it cannot be marketed as “Made in Singapore,” as this designation necessitates significant manufacturing or processing within the country.
Importance of Free Sale Certificate (FSC) and Certificate of Origin (COO)
When exporting goods, obtaining a Free Sale Certificate (FSC) and a Certificate of Origin (COO) can significantly streamline the process and enhance market acceptance in your destination country.
- Free Sale Certificate (FSC): Issued by Singapore Customs, the FSC confirms that the products are sold locally in Singapore and are compliant with local regulations. It serves as a testament to the product’s quality and safety, making it easier for foreign authorities to accept the product without extensive scrutiny.
- Certificate of Origin (COO): This document attests to the origin of the goods and is essential for international trade. Many countries require proof of origin to determine applicable tariffs and compliance with trade agreements. There are two types of COOs:
- Ordinary COO (Non-Preferential): Identifies the origin of the good but does not allow overseas buyers to claim preferential tariff treatment, as it is not issued under any Free Trade Agreement.
- Preferential COO: Enables your buyer to benefit from lower or no customs duty when exporting under a Free Trade Agreement or Schemes of Preferences.
Steps to Brand Your Complementary Health Products or Cosmetics as “Made in Singapore”
- Set Up a Manufacturing Facility: Establish a manufacturing facility that adheres to Good Manufacturing Practice (GMP) requirements to produce your product, or partner with a licensed contract manufacturing facility that specializes in complementary health products. Ensure that your facility is registered with relevant authorities to facilitate inspections and audits.
- Ensure Regulatory Compliance: Comply with the relevant regulatory controls for your type of health product. Prepare comprehensive documentation to establish the quality, safety, and efficacy of your product. This documentation should include:
- Product specifications
- Safety data sheets
- Clinical studies (if applicable)
- Quality assurance protocols
Seek the appropriate approvals before marketing and distributing it locally. This may involve obtaining licenses to import and distribute if necessary.
- Obtain Necessary Certifications: Once you receive approval from the regulatory authority, you can apply for a Free Sale Certificate from Singapore Customs or a Certificate of Origin from the Singapore Manufacturing Federation and the Singapore International Chamber of Commerce to facilitate exportation, depending on the domestic procedures of your destination country.
- Free Sale Certificate: To apply for the FSC, submit your application along with supporting documents that demonstrate your product’s compliance with local regulations. The certificate will detail the product’s description, registration numbers, and the local regulatory authority’s confirmation.
- Certificate of Origin: To obtain a COO, you will need to provide documentation that supports the origin of your goods. This may include:
- Invoices
- Shipping documents
- Manufacturing process details
COs are issued by the Singapore International Chamber of Commerce and the Singapore Manufacturing Federation. Ensure that you are familiar with the requirements of the importing country to facilitate a smooth export process.
For further information, please refer to the following resources:
We hope this information proves useful to you. Be sure to check out our other related blogs that may interest you:
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.
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.
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.
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.
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.
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.
