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.

Whether it is hardware or software as a service – subscription services are rising to prominence in our daily lives. However, mention our subscription plan for regulatory affairs, and some might be left scratching their heads. While this is an understandable reaction to a layman, our subscription plan can aid businesses in need of regulatory assistance. 

In particular, medical companies may find our plan indispensable, given the nature of the industry, where regulations, standards, and best practices continuously evolve, thus necessitating constant vigilance and resources to maintain compliance. For those unaware of its benefits, let us delve into why businesses in the medical industry can benefit from our subscription plan.

Benefit #1: Stay Up-To-Date With The Latest Regulatory Changes

Staying abreast of the various regulatory and guideline changes and updates can be akin to navigating a complex maze, especially if the business operates in a new territory where the best practices differ significantly from its country of origin. Its unfamiliarity with local regulatory guidelines may cause it to work with outdated, incorrect information.

Our subscription plan allows companies to tap on our local expertise as a regulatory service provider to advise on regulatory issues revolving around their business plans and products. Our consultants regularly keep up-to-date on the latest regulatory changes and can provide real-time updates and insights into evolving guidelines pertinent to the industry. This helps businesses to come up with proactive compliance strategies and mitigate the risk of non-compliance penalties and reputational damage.

Benefit #2: Oversee Regulatory Affairs

Effective regulatory compliance requires robust oversight and management. So, beyond staying informed on the newest changes, it is essential for businesses to maintain comprehensive and precise oversight of their regulatory affairs. However, this can be challenging for those unfamiliar with local regulations and guidelines.

As part of the services offered by our subscription plan, our consultants can help manage various aspects of the enterprise’s regulatory affairs. This includes updating operational standard operating procedures (SOPs), conducting training for distributors based on materials prepared by the client, and attending meetings as the company’s regulatory affairs representative. That, in turn, empowers businesses to oversee their regulatory affairs with precision and confidence.

Benefit #3: Comprehensive Compliance Support

With our regulatory affairs subscription plan, businesses can access our comprehensive tools and resources tailored to streamline compliance processes. We can help expedite compliance tasks, fostering operational efficiency and risk mitigation, ensuring companies encounter minimal issues when expanding into a new market.

Benefit #4: Cost-Effective

Our regulatory affairs subscription plan offers a scalable and economical means of achieving compliance excellence, with comprehensive regulatory information and resources readily available. As a result, businesses can eliminate the need for costly in-house expertise and infrastructure.

Instead, by leveraging our local expertise to perform the work on their behalf, enterprises can eliminate the worry of rising costs while redirecting available resources to focus on more crucial objectives, such as growing and expanding the company.

Regulatory affairs management extends beyond product registration and securing the necessary approvals for marketing and distribution. Our subscription plan can help streamline the entire process, providing comprehensive support even after the initial registration stage and allowing businesses to maintain sustainable growth and ethical conduct in today’s regulatory environment. Contact us today if you are interested in learning more about our subscription plan.

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!

Regulatory compliance in the healthcare industry is essential to maintaining quality standards and preventing fraud and abuse, thus ensuring patient safety. However, local and overseas pharmaceutical and medical companies seeking to register their medical products in Singapore may find navigating the numerous regulations governing their operations overwhelming and time-consuming.

Due to the dynamic nature of the healthcare industry, staying abreast of regulatory changes is not just a best practice; it is a fundamental necessity. To help healthcare organisations adapt swiftly to new requirements and maintain compliance, let us explore the strategies for effectively navigating the various health product regulations in Singapore’s healthcare industry.

1. Stay informed through official sources

The cornerstone of regulatory compliance lies in staying informed. However, with widespread misinformation and speculations prevalent on the internet, it can be challenging to pinpoint the authenticity of a source. So, the best way to stay up-to-date on the latest and most accurate changes to existing health product regulations is to monitor official regulatory channels like the Health Science Authority (HSA). 

As the relevant regulatory authority on the healthcare industry in Singapore, HSA’s platform is the most trusted source for comprehensive and authoritative information on the latest healthcare regulations. Whenever there is an update, arrange a training session to ensure the medical staff is educated on the newest updates and is aware of the importance of adhering to them.

2. Leverage industry associations and professional networks

Besides turning to HSA as a trusted source of information, medical companies can leverage professional associations and networks in the healthcare industry to stay abreast of the latest regulatory changes. Due to their relevant ties to the industry, these platforms often provide valuable updates, insights, and guidance from industry experts.

Businesses can attend conferences, seminars, and workshops to network and stay connected with like-minded peers and experts. Engaging with and building partnerships with others in the industry can facilitate knowledge sharing, providing valuable insights into best practices and proactive approaches to navigating health product regulation changes.

3. Develop robust internal processes

Effectively navigating regulatory changes requires more than awareness; it demands dynamic internal processes that promptly react to new requirements. That is why every healthcare organisation should implement a comprehensive compliance programme tailored to their specific needs if they have not done so already.

This programme should include robust protocols for monitoring and addressing essential regulatory requirements, with a dedicated regulatory affairs management team responsible for oversight, providing regular staff training on compliance matters, and establishing mechanisms for reporting potential violations.

4. Regularly assess compliance and identify gaps

Regulatory compliance is an ongoing process necessitating regular self-assessment. By conducting regular internal audits of operations and documentation, healthcare organisations can identify and proactively address potential gaps before they manifest into significant problems. Such actions not only ensure long-term compliance. They also enhance the business’s ability to address shortcomings in processes and procedures.

5. Consult legal and regulatory experts

Healthcare organisations unsure of the best way to ensure their products comply with existing health product regulations should seek expert advice. A regulatory consulting service specialising in the healthcare industry will possess in-depth knowledge of the nuances of Singapore’s healthcare guidelines and can provide tailored guidance to navigate complex changes while ensuring compliance, thus minimising the risk of legal issues and penalties.

Learn More: The Role of Regulatory Affairs Management in International Expansion for Pharma Companies

The ability to navigate regulatory changes seamlessly is crucial to success in the dynamic realm of the healthcare industry. By taking a proactive approach to regulatory navigation, healthcare organisations can navigate complexities with confidence, uphold their stellar reputation, and contribute to the ongoing enhancement of healthcare standards in Singapore.

Remember, the healthcare landscape in Singapore may evolve. However, your commitment to compliance should remain steadfast. At The Reg Consultants, our regulatory affairs management team can help you stay informed and compliant, ensuring you can continue providing excellent patient care. Contact us today to learn how we can work with you to support your operation’s needs.

It has come to the end of the year where budgeting and planning are in full force for 2024.  In regulatory, we do it via the RPA way which stands for Review, Plan and Act .

TRC shall share a short summary on what RPA means :

Review

1. Start off with product annual review to check for gaps and alignment with global database.
2. Align the schedule and activities with headquarters for the upcoming year so that you can roll out the relevant schedule and communication plan.
3. Prepare communication plan or schedule of upcoming variations and new product registrations for each specific market and inform respective partners of the timeline and what to expect. This is an important exercise to also get input on any new regulatory requirements that might be happening within the local market.
4. Identify key areas to work on internally as well as with respective local partners.

Plan

1. Align the regulatory launch plan with commercial launch plan and obtain consensus on priorities of the variations and new product launches.
2. Budget the amount required for respective expenditures to partners, authorities, operating expenses ,travel expenses, any pass-through costs involving translation work if applicable .
3. Plan for face to face meeting and annual audit with respective partners as part of due diligence and to maintain the good rapport between yourself and them if applicable.
4. Ensure that consensus on activities and budget are obtained and accurate till date.

Act

1. Hold meeting with internal and external stakeholders to confirm the plan.
2. Adjust the plan and schedule accordingly after meeting to ensure alignment to concerned parties’ inputs.
3. Prepare the respective packages for each product that is specific to each market.
4. Execute the plan accordingly to schedule and be ready to support when issues arise.

We hope the above short sharing is interesting for your read. If you need support for your regulatory activities in the coming year in Singapore, feel free to get in touch.

 

During the expansion of territory in the traditional  business model, there will be multiple distributors that manufacturers must deal with. Unlike big companies that have a dedicated staff looking after the region. Smaller companies  or companies that do not have a local office established in the territory will rely on their business manager who might not be as well versed in regulatory as a “project manager.”

Sometimes it might lead to some miscommunication regarding the requirements since the meeting with the local companies would be limited hence it might be worth to consider having a regulatory project  manager to oversee the local regulatory experts  so to ensure alignment with regulatory goals and objectives set out by the headquarters.

Regulatory project management in TRC’s term is about managing data flow from the local experts to a centralized system where it is updated, accessible and reliable for the global headquarters to have visibility in terms of product licenses compliance.

Below are 5 tips to share on regulatory project management:

1. Maintain and establish a good friendship with local regulatory experts.

This will play a big role when manufacturer would want to transfer the licenses back to their own name or switch distributor.  Based on observation, relationship tend to sour during the announcement and the local regulatory personnel will play a critical role to mediate the whole situation.

2. Establish clear timelines and achievable expectation in terms of market feedback.

Headquarters  would roll out several variations decision consecutively expecting the local experts to provide an assessment on the risk, impact on the product line as well as the documentation requirements  in a short notice which would not be feasible. At times, the variation that are to be executed might not fall into any appropriate MIVs / Change notification category and local experts will need time to verify with the authority before providing a decision. It would be worth to consider establishing a schedule of upcoming variations/change notification and implementation timeline for each product line for each quarter to share with appropriate partners.

3. Conduct regular reconciliation of regulatory information regarding the product licenses with individual partners to align with what is captured in the system.

To do this appropriately, it would be good to have a 1 hour focused call weekly if necessary to run through all the information and questions if not a bi-weekly catch up to just check for any new updates or situations or support that might be required from the local regulatory partners. 

4. Always be ready to support and facilitate any miscommunication or requirements from both ends.

The regulatory project manager must digest then interpret the requirements from both ends and align the understanding with the local experts and headquarters before going to either party to clear the air.

5. Prioritize the most critical issues to be addressed instead of bugging the local experts repeatedly to answer a question.

In the situation where there are several critical issues e.g., site change, change of  supplier of excipients, minor update on labelling to reflect the new EC representative details, , the regulatory project manager will need to have visibility of each local market situation from both the regulatory and commercial front. This is to enable  the regulatory project manager to  strategize and rank the issues to be addressed first  in terms of the impact on sales, compliance, and implementation so  to advise the local regulatory partners appropriately.

Synergy in regulatory project management emphasizes heavily on being systematic, having clear understanding of the ground issues and maintain a good relationship with the local regulatory partners to ensure succession execution. TRC subscription plan would be able to facilitate this activity should you require support. Feel free to reach out if you need help or stay tuned for the next blog.

 

As a regulatory service provider aka consultant, each regulatory consultant has their own unique way of execution of regulatory task especially for regulatory submission.  However it would not differ too much from what we are going to share with you.

TRC would like to share with potential prospects of how we usually manage regulatory submission.  Please refer to the steps below:

1. To initiate the regulatory submission flow, TRC would request Client to provide a secured link for us to access the dossier.
2. When dossier is downloaded , TRC would first begin to verify that all sections of the CTD is provided and also verify the file size . For file size exceeding the uploading size onto submission platform, a request would be sent to the Client to split the pdf into smaller size and re-send it to us.
3. TRC would execute minor formatting such as renaming of modules if not named appropriately as an example. However, TRC do not do any publishing or formatting of CTD to e-CTD.
4. A gap analysis exercise is conducted to identify the points to be addressed prior to submission accordance to classification of the product and evaluation pathway. The gap analysis report will be sent to the prospect to work on the gaps for our review. This would usually take about minimum of 3 round and not exceeding 5 rounds.
5. Once the gaps are addressed, we would proceed to perform online submission including the application form filling and uploading of documents.
6. Once submission is completed, TRC would furnish the entire set of dossier and a copy of the submission form to the prospect for their reference. TRC also perform our due diligence to keep track of the timelines to receive 1^st set of screening queries and between stages throughout the evaluation process to ensure that the submission is on track.
7. During the evaluation process, TRC lends their support by facilitating and reviewing the responses provided by the prospect to answer to the queries raised by the evaluator. Similarly, TRC would take the initiative to clear any doubts with regards to the query letter raised to support the prospect to provide the required responses. This is to ensure that each round of evaluation process would be well answered and to avoid duplication of questions from both ends.
8. Once approval is received via email, TRC will notify the prospect and remind the prospect to take note of the post-licensing condition imposed in the notification email.

We hope that above  has been useful for you if you are contemplating to engage us to support your regulatory submission in Singapore. Do reach out or explore TRC’s new and articles to navigate through article that are useful to you.

Fueled by a consumer base eager to try out new, up-and-coming products from around the world, Singapore’s cosmetics and personal care industry has experienced remarkable growth in recent years. However, this surge has also caused the demand for quality to rise, with more customers expecting better efficacy and product safety. This increases the challenge that companies in the cosmetics and personal care sector face with regulatory compliance. In this article, we’ll talk about the regulatory challenges that companies should pay attention to and the steps that need to be taken to ensure product safety, compliance, and sustainable growth. 

Learn More: 3 Facts to Know When Importing Cosmetics Into Singapore

1. Product Safety Assessment

The Health Sciences Authority (HSA) has made it mandatory for manufacturers to conduct rigorous safety assessments, such as toxicological evaluations, to identify any potential risks that their products could cause. This is because, all products, whether for medical applications or personal care, must be safe for use and must not cause any adverse reactions that could pose an issue for public health. 

2. Ingredient Restrictions

Apart from product safety assessments, HSA has also established strict regulations regarding the use of specific ingredients in cosmetic and personal care products to further ensure safety. 

Businesses must review and update their product formulations regularly to remove restricted ingredients or limit their use in order to comply with these regulatory standards. Additionally, they should invest in research and development to identify safer alternatives, and collaborate with suppliers who provide compliant raw materials. 

3. Product Labelling and Packaging

All product labels are required to display essential information about the product to provide customers with accurate information about what they are purchasing and for regulatory authorities to trace products in case of issues. They should include the manufacturer’s contact details, product name, a detailed ingredient list, warnings, and clear usage instructions.

To meet these requirements, businesses must work with designers and regulatory experts to craft labels that adhere to the guidelines, as well as conduct regular reviews of packaging and labelling to ensure they remain compliant with changing regulations. 

When it comes to complying with product labelling guidelines, there are numerous intricate details that require attention. We recommend working with a regulatory consulting service to ensure that you do not miss out on any key information.

4. Substantiating Claims

Any product claims, such as “anti-ageing” or “skin whitening,” must be substantiated by scientific evidence. HSA closely monitors these claims, and businesses advertising any misleading or unsupported claims can face penalties. 

If companies wish to include any of these claims in their product information or advertisement, research findings and data from scientific studies and clinical trials must be provided to validate these claims. Businesses can also work with qualified dermatologists or experts in related fields to conduct independent assessments of product efficacy. 

Otherwise, one simple way to ensure compliance is to avoid the mention of these terms. 

5. Good Manufacturing Practices (GMP)

Lastly, companies are required to follow a set of good manufacturing practices in order to better guarantee product quality and safety. They include, but are not limited to:

• Maintaining cutting-edge facilities designed to prevent contamination and ensure cleanliness
• Maintaining comprehensive records of manufacturing processes, testing, and quality control procedures
• Proper storage and distribution practices
• Providing adequate training and education to employees.

Regulatory affairs management in Singapore’s cosmetics and personal care industry is difficult to navigate but an important step to go through. By addressing the above-mentioned challenges effectively, companies can not only ensure compliance with local regulations but also enhance their reputation and competitiveness in the market.

The Reg Consultants is a regulatory service provider that offers both local and overseas cosmetics and personal care companies regulatory assistance. Contact us today to find out how we can help you. 

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:

Documentary requirements for imported products are listed below:

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.

Key pointers before registration

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 Reference:

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.

 

Cosmetic products are substances or mixtures designed for use on the external parts of the body, such as the skin, hair, nails, lips, and teeth, for the purpose of cleansing, perfuming, protecting, or enhancing appearance. In Singapore, all cosmetic products must comply with safety regulations and require a cosmetic product notification before they can be distributed or sold. This ensures the products meet health and safety standards established by the Health Sciences Authority (HSA).

The cosmetic product notification process in Singapore is a regulatory requirement administered by the Health Sciences Authority (HSA). Before any cosmetic product can be sold or distributed in Singapore, it must be notified to the HSA through the Cosmetic Products Notification Portal (CPNP). This procedure ensures that products meet ASEAN Cosmetic Directive standards, are free of prohibited substances, and comply with safety guidelines regarding labelling, claims, and ingredients.

Cosmetics are required to be notified through the cosmetic product notification process before they can be sold in the market unless they fall under the circumstances below:

1. Supplied solely as a sample in connection with any advertising, sponsorship or promotional activity
2. Supplied solely for testing or trial use in connection with any research or development of that product
3. Manufactured by or in accordance with the specifications of a medical practitioner and supplied solely by that medical practitioner for the use of patients under his care

 

Before supplying cosmetics in Singapore, we need to perform the following steps:

1. Determine If The Product Meets The Definition Of Cosmetics

We need to determine whether the cosmetic product meets the definition of Cosmetic in the local context. As shared in the previous article: https://theregconsultants.com/regulatory-classification-of-medical-products/, a “cosmetic product” is defined as any substance or preparation designed for application to the external parts of the body, including teeth and oral mucous membranes. These products must undergo a cosmetic product notification process before they can be legally marketed in Singapore.

• Cleaning
• Perfuming
• Changing appearance
• Correcting body odours
• Protecting
• Keeping in good condition

 

Examples of products that are not cosmetics are:

• Oral supplements for beauty purposes
• Injections/injectable products
• Massage and essential oils
• Aesthetic/beauty devices
• Lubricants
• Insect repellents
• Sanitary pads
• Hand sanitisers
• Creams for treating acne, eczema, and psoriasis
• Toothbrushes
• Dental floss
• Detergents
• Temporary tattoos
• Fake eyelashes
• Nail stickers
• LED lights used in dental kits (note that whitening gel is considered a cosmetic product)

 

2. Consider If The Manufactured Product Meets Specifications And Testing Criteria

In terms of product safety, we need to consider the main components, such as the composition, labelling, claims, and whether the product manufactured meets the specifications set. Additionally, the product must go through a cosmetic product notification process, including safety evaluations, to ensure compliance with local regulations.

We must ensure that cosmetic products do not contain ingredients on the negative list based on the ANNEXES OF THE ASEAN COSMETIC DIRECTIVE.

Labelling of cosmetics should contain the key information below:

1. Name of the cosmetic product
2. Function of the cosmetic product
3. Instructions for use
4. Full ingredients listing
5. Country of manufacture
6. Contents (weight/volume)
7. Batch number
8. Manufacturing/expiry date (expiry date is only required for products with less than 30 months durability)
9. Name and address in Singapore of the company responsible for placing the product in the market
10. Special precautions, if any (especially those listed in Annex III, VI, VII in the ASEAN Cosmetic Directive)

 

Cosmetic claims should be appropriately assigned based on the key ingredient function, target site of application, and physiological effects of cosmetics. Some examples of claims that are unacceptable in accordance with the ASEAN Cosmetic Claims Guide can be found here:

To ensure regulatory compliance, the product must undergo cosmetic product notification. This includes verifying that the manufacturer follows Good Manufacturing Practices (GMP) or ISO standard 22716:2007, conducts local testing for potential contaminants, and ensures the product is free from common adulterants.

Examples of appropriate testing on products are provided below:

Product Type	Claims
Teeth whitening products	To test the concentration of hydrogen peroxide. Hydrogen peroxide, when in high concentrations, is corrosive and may cause irritation to the eyes, mucous membranes, and skin. Only products with hydrogen peroxide of concentration up to 0.1% can be allowed for supply to consumers directly.
Skin Whitening creams	To test for the presence of adulterants e.g., Hydroquinone, tretinoin, and mercury. Hydroquinone and tretinoin are potent ingredients that are not suitable for use in skincare cosmetic products. The inappropriate use of hydroquinone could result in changes in skin color and hypersensitivity reactions such as rashes, redness, tingling, and burning of the skin. Tretinoin could lead to redness and peeling of the skin and should only be used under medical supervision.

 

3. Essential Items That Need To Be Kept On-Site

Cosmetic product notification should be performed by appointed companies that intend to import or sell cosmetic products in the market.  As cosmetic products are not evaluated by the authorities, it is important for importers to be responsible for the safety and quality of the product.  There are three main things that should be maintained on-site for the importer, namely:

• Product information file: This file contains all the quality and safety records of the cosmetics to comply with the relevant standards. It should be kept updated in accordance with what is happening at the manufacturing end that could impact your product.
• Records of cosmetic supply to the market: Records should be maintained for two years in accordance with the Guidelines on the Control of Cosmetics. The record should contain the product’s name and notification number, the company’s name and address, and the batch number, date, and quantity of the product supplied.
• Monitor and report any product defect/adverse events to the authority and perform a prompt recall for the product: The reporting timeline is seven days for adverse events that are life-threatening or result in death and 15 days for adverse events that result in hospitalisation or any persistent or significant disability or incapacity.

 

To cap off the article, here are some useful links for you to kick-start the process:

1. Guidelines on the Control of Cosmetic Products
2. ASEAN Cosmetic Directive
3. Overview of how the local authority regulates cosmetic  
4. HEALTH PRODUCTS (COSMETIC PRODUCTS — ASEAN COSMETIC DIRECTIVE) REGULATIONS 2007

Frequently Asked Questions

1. What is cosmetic product notification?

Cosmetic product notification is a regulatory requirement by the Health Sciences Authority (HSA) in Singapore. All cosmetic products must be notified before they can be sold to ensure compliance with safety standards.

2. Which cosmetic regulation does Singapore follow?

Singapore follows the ASEAN Cosmetic Directive, which establishes guidelines for cosmetic product safety, labelling, and claims. Products must undergo cosmetic product notification before entering the market.

3. Do I need a cosmetic product safety report for notification?

Yes, during the cosmetic product notification process, safety assessments, including toxicological evaluations, must be conducted to ensure the product is safe for use.

4. What is HSA cosmetic product notification?

HSA cosmetic product notification is a mandatory process that ensures cosmetic products meet Singapore’s regulatory and safety standards before being sold.

5. What is the process for notifying cosmetic products in Singapore?

The process is carried out through the Product Registration and Information System (PRISM). Manufacturers and importers must submit the required information and documentation to the Health Sciences Authority (HSA) via this online platform.

Ensuring that your cosmetic product meets Singapore’s stringent regulatory requirements is key to a successful launch in this dynamic market. If you need support with the cosmetic product notification process or have questions about compliance, don’t hesitate to reach out to us.

Our team is ready to assist you in navigating the complexities and ensuring your products align with all local regulations. Share our services with peers who may benefit, and let us simplify your compliance journey together.