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

1. Quality of the CMC documents- Drug Substance

a)     GMP Compliance: Starting from October 2024, compliance with Good Manufacturing Practice (GMP) regulations will be necessary for drug substance manufacturers in Singapore. This requires either a valid GMP certificate issued by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) authority or a Certificate of Suitability and valid Active Pharmaceutical Ingredient (API) registration certificate covering the drug substance of interest listed on the European Union Drug Regulatory Authorities (EURDRA) GMP. Without these documents, product registration in Singapore will not be possible.

b)    Specifications: Specifications and limits  for the drug substance must be established in accordance to validated analytical methodology and based on understanding of the manufacturing process and data collected from the course of stability studies, stress testing and process validation . Reference to ICHQ2 and Q6A will be appropriate. The drug product manufacturer should have final control over the quality of the drug substance incorporated into the final formulation. Therefore, the drug product manufacturer should maintain  a final controlled version of the drug substance specifications.

c)     Process Validation: Process validation data should be submitted in accordance with the requirements outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M4Q guidelines.

d)    Stability Studies: Stability data from at least three primary batches, two pilot batches, or one small-scale batch should be submitted from the drug substance manufacturer based on ICH Q1 requirements. If the drug substance is sourced from multiple sites, stability data from each site should be provided. Additionally, stress testing data should be submitted to assess the stability of the drug substance under various conditions.

 2. Quality of the CMC documents- Drug Product

a)  Certificate of Pharmaceutical Product (CPP) –Proof of approval should be in World Health Organization (WHO) format and issued from the country of origin or the country where the product owner/manufacturer is based. If the CPP indicates that the product is not marketed, it will not be accepted.

b)    GMP Compliance- The drug product (DP) manufacturing site should have valid proof of Good Manufacturing Practice (GMP) compliance at the time of submission. Singapore follows the standards of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines. The manufacturing site should evaluate compliance with PIC/S standards. For more information, you may check out this article: https://theregconsultants.com/registering-an-overseas-manufacturing-site-in-singapore-for-pharmaceutical-products/

c)    Specifications of the Drug Product – Specifications and limits for the drug product should be established and conducted based on validated analytical procedures in accordance with ICH Q2 and ICH Q6A guidelines. These specifications govern the release and stability of the drug product which impacts on the safety and quality of the drug product.

d)    Process Validation – Process validation data requirements depend on the type of dosage form, including solid oral drug products, aseptically processed drug products, and terminally sterilized drug products. Submission should include data from three consecutive manufactured batches according to the proposed manufacturing process and batch size.

e)     Stability-  Stability studies should cover data specified for Zone IVb (30°C/75%RH) and include data from three primary batches of 12 months for critical dosage form such as injectables  and two primary batches of  6 months for conventional dosage form such as tablets and capsules . Studies should be conducted according to the proposed batch size, strength, and container closure system intended for marketing in Singapore.

3. Clinical efficacy

a) Acceptance of Foreign Clinical Trial Data –Most ASEAN countries, including Singapore, accept foreign clinical trial data. This means that data generated from clinical trials conducted outside of Singapore can be used to support product registration in these countries as long as they are conducted in accordance to GCP guidelines and relevant ICH guidelines.

b)Phase III Confirmatory Trials –To support each requested indication and dosing regimen for the product being registered,  data from Phase III trials, which are confirmatory, randomized, controlled pivotal trials, compliance with Good Clinical Practice (GCP) guidelines is required.

c) Bridging Studies/Comparative Studies –In the case of biosimilars and generics, bridging studies or comparative studies may be required. These studies aim to demonstrate that the biosimilar or generic product is comparable to the reference product in terms of pharmacokinetic (PK) and pharmacodynamic (PD) parameters. The goal is to show that there are no significant differences between the test product and the reference product in terms of safety and efficacy.

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

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

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

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

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

     

     

     

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

     

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

     

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

     

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

     

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

     

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

     

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

     

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

     

    The ASEAN Joint Assessment Procedure is a procedure in which the same marketing authorization application is simultaneously submitted to all participating ASEAN National Medicines Regulatory Authorities (NRAs).

    ASEAN National Medicines Regulatory Authorities (NRAs) includes:

    • Health Sciences Authority (HSA)- Singapore
    • National Pharmaceutical Regulatory Agency (NPRA)- Malaysia
    • Thai Food and Drug Administration (Thai FDA)
    • Food and Drug Administration (Philippines FDA)
    • Badan Pengawas Obat dan Makanan (BPOM),Indonesia
    • Drug Administration of Vietnam (DAV)
    • Ministry of Health, Brunei (MoH, Brunei)
    • Department of Drugs and Food (DDF), Cambodia
    • Food and Drug Administration Myanmar
    • Food and Drug Department (FFD) , Laos

    The join assessment procedure is initiated with minimum of 3 NRAs.

    At the moment , it covers only :

    1. a) medicines for treatment of priority diseases in ASEAN region such as but not limited to: treatment for specific cancers such as breast , lung, Hepatitis C, treatment of AIDS/HIV, Tuberculosis, Treatment-Resistant Depression.
    2. b) products already approved by a reference National Regulatory Authority(NRA) ,prequalified by WHO-PQP, or assessed through special regulatory pathways such as EU Article 58 or US-FDA tentative approval;
    3. c) products manufactured in a PIC/S-GMP compliant site

    Process in brief

    1. Participating National Regulatory Authority(NRA) publish on their website in the form of a Notice : Notices of Invitation to Express Interest.
    2. Applicant can submit their interest by filling up the appropriate application form to the authority.
    3. Lead NRA seeks concurrence of participating NRAs for accepting Expression of Interest
    4. Lead NRA requests applicant to submit required documentation to participating NRAs.
    5. Assessment work is then carried out together by all participating NRAs and a joint assessment report is prepared
    6. At the end of the process, the final decision on the application is then taken, within established time lines, by each individual NRA through their normal decision-making process based on the joint report and, where applicable, nationally-relevant considerations.

    Applications must comply to the following:

    1. the technical application dossier must include the same technical information as that submitted to reference NRA or WHO-PQP;
    2. b) the technical part of the dossier in ACTD or ICH-CTD format shall be provided in electronic form to be uploaded to a dedicated, secure web site set up by WHO; only participating NRAs will be able to access and download the dossiers;
    3. c) administrative part of dossier specific to each participating NRA requirements will be submitted directly to each participating authority;
    4. d) fees as required by each participating NRA will be paid according to normal national procedures.

    Processing timeline: 180  working days for assessment procedure

    If you have a product that may fall into the therapeutic area mentioned  and need support for submission, please feel free to get in touch with TRC.

    Useful references:

    1. List of Priority Products
    2. Processing timelines
    3. ASEAN-JA-Procedure-for-Pharmaceutical-Products-Information-for-Applicants

     

    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.

    1. 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.

    1. 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. 

    1. 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.

    1. 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.

    The next step after performing a regulatory intelligence exercise would be followed by an arrangement for a consultation with the regulatory authority. This is common especially for IND application and NDA application in which there may be concerns regarding the documentation requirements or even addressing any critical CMC, pre-clinical and clinical study related questions. Today TRC shall share based on observation from the past on what’s the Dos and Don’ts during a formal regulatory consultation meeting in tabular format:

    Note that this is just based on TRC’s suggestion of best practice and we do not advocate or represent any voices.

    Dos Don’ts
    Present your best self by dressing appropriately and finding a quiet place to participate in the meeting.  Switch on the camera during video call meeting. Do not appear as an unkempt look  or even join the meeting in a noisy place to create unpleasant “white noise” during the meeting. If you are unable to switch on the camera during the call, remember to inform during the meeting.
    Ask questions that are within the meeting agenda provided.

     

    Do not ask questions for the sake of asking questions if they are not necessary.

     

    In a regulatory meeting, there will be different department personnel joining in. But it would be best to limit those who are  executing the work and have an influential decision on how to move the application forward to avoid any unnecessary question or awkward silence to have a need to ask question.

    If the explanation is not clear or specific enough even though the time is running out, ask politely whether you could clear out this important issue so as not to leave it hanging.

     

     

    Do not keep pressuring the regulators to double confirm the answers that they are providing. A written response would be provided at the end of the meeting. If there is anything that is not clear, you can write back again once the email is received.
    Be respectful and transparent about the application that you are intending to submit. Give an overview of the application preparation and the objectives of what you intend to achieve within the meeting. Do not have more than “one” voice interrupting the flow and “ over talking” about the application that you are intending to submit during the meeting to avoid any confusion or misunderstanding which will not provide you with the appropriate response that you are looking for.
    Follow a systematic approach to start off the meeting which is by being punctual, following the agenda of the meeting strictly and avoid any over discussion so  as to not waste any precious time allocated. Do not trail off the main questions during discussion and allow the regulator to provide the guidance and ask the next question in sequence unless the question that you have in mind is extremely critical or related to the response that you are hearing.
    At the end of the meeting, it’s good to pre-empt or suggest a follow up “informal” call by a designated representative should there be any concern that is not well understood from the formal responses provided. Consolidate all the queries that you have in mind after reviewing the responses provided by the regulators and avoid  bombarding them with calls from different people. They are not your answering machines.

     

    If you think that the above article is useful for you , feel free to share it with your peers and we are also looking forward to hearing some of your experience during consultation meeting. If you require assistance to arrange and support any formal meeting with the local authority, get in touch!

     

    Part of our routine activity in regulatory affairs is to stay in touch with the latest updates and happenings with our local authority so that we can interpret the new changes, assess the impact it has on our existing product licenses and implement a strategic plan to incorporate the changes. Today TRC would like to share the key steps in a typical internal regulatory assessment of new regulations changes:

    1. Understand the regulations thoroughly

    Ensure that you obtain  the latest draft or correct version of the new regulations and read the context in dept. Compare it with the current regulations and make notes on the differences that could be important for you to bridge the gaps.

    When the draft guidelines are issued for consultation,  ask all the questions that you have in mind to align your own understanding and to clear any doubts regarding the new changes.

    If there are training sessions conducted by the authority prior to the implementation, it will be good to participate so as to refresh your memory and to enhance the understanding and learn about any new concerns during the Q and A session from other participants.

    1. Perform an internal assessment

    Determine the BU (business unit)  and product line that will be affected by the new regulations. Obtain the status of the marketing authorization and a brief understanding of the  commercial status of the product in the territory involved.  

    Perform a gap analysis and document the gaps in  order to bridge and incorporate the new change. This should be documented as concise and to the critical point as possible. Share the internal assessment document  with the appropriate business unit to obtain feedback so that you can align the findings that you have identified during the gap analysis.

    1. Determine the steps to incorporate the change

    Using the internal assessment as a guideline, prioritize changes in terms of criticality,  the commercial impact on the product line and the resources available to support the implementation. Draw up a plan to  strategize the implementation and align with local stakeholders and business unit on the requirements and timeline.

    Monitor the process of implementation and review post implementation for areas of improvement and effectiveness as well as to capture any areas that were missed out during the initial phase of implementation.

    Although the above steps are simple , there may be a risk of miscommunication and  lack of internal resources when simultaneous of such regulatory changes are implemented, it could be useful to consider an additional experienced local support . If you think that TRC could be of help to you , please get in touch or learn more about how TRC subscription plan can facilitate the process.

     

    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 1st 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.

    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”
    1. 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
    1. 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.

     

    Cosmetics are required to be notified 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 my 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, primarily for:

      • 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, whether the product manufactured meets the specifications set, and whether appropriate testing has been performed to ensure that the product is safe and functions as it is claimed.

      We need to 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:

          In order to make sure that the product manufacturer meets international requirements, it would be appropriate to be certain that the manufacturing facilities have the relevant certification that complies with GMP or ISO standard 22716:2007, perform local testing if required to check for heavy metals and microbiological content and check for 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 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

           

          If you need any support to confirm that your cosmetic product meets the local requirements, feel free to contact us or share it with your peers who might need our services.