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

 

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

 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

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

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

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

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.”

regulatory project management

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.

regulatory consultation meeting

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!

 

 

What are Regulatory Affairs Subscription Plans

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.

Common Technical Dossier

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.

A regulatory subscription plan is a newly launched product created by TRC to support medical companies in need of regulatory assistance in a new territory where there is no local office established /when there are only requirement to support post-licensing activities / when additional or alternative support will come in handy when getting the right person on board proves to be difficult/ when you want to explore an alternative way of running your regulatory department /when there are certain conflict of interest between parent company and local company in which an independent party will be useful.

 

Regulatory Subscription Plan

The plan allows you to leverage upon a local expertise to perform the required daily regulatory tasks associated with a typical regulatory specialist and head of regulatory operations.  pertaining to the routine operational works on an adhoc basis, tie over peak periods, maternity cover for a short period of time relating to specific regulatory initiatives and  project management from a ASEAN perspective

We present a simple comparison chart of Regulatory Subscription Plan Vs Traditional Model.

Comparison parameters Regulatory Subscription Plan Traditional Model
Working Principle Flexible model of rendering regulatory expertise who is already experienced in the local market. Hiring a staff to manage the regulatory work based on requirements.
Cost It is a fixed cost for experienced personnel.

 

Can be more cost effective as opposed to having a regular staff if company is just planning on performing post licensing activities and ad-hoc new launched activities .

Can vary depending on the level of expertise from personnel engaged.

 

Can incur more cost in the long run and cause distress if company decided to downsize or retrench due to economic outlook.

Manpower Resource readily available with years of experience.

 

Dedicated serving regulatory personnel assigned ( no project manager and etc).

 

 

Need time and resources to train before work can be done.

 

Dedicated employee .

 

Resource allocation  and commitment No commitment basis for the plan.

 

 

 

Able to support various functions which can stretch to pre-product launch such as market research, mediation activities and even audit.

 

Commitment required for employment even on contractual basis. If not handled properly might have litigation issues.

“Safe mode” to follow

Fixed duties and function for employee – no flexibility to take on other tasks which is out of scope

 

Determining factor in choosing the right model Have no local office and need someone experienced to kick start the whole process of filing to minimize loss in lead time for product launches.

Limited budget with short time frame on deliverables

Have a non-committed alternative support for the regulatory work to cope with the temporary “lull” period while deciding on the next move for the company or even to support the team while there is internal restructuring which initiatives might still be required to go on.

Have a short trial on a possible operation model of the regulatory function which might be useful in the long run to deal with unexpected circumstances .

 

Established presence in the territories for years with good working relationship among partners and staff.

 “Expandable budget” to establish own team with a rather flexi timeline

A committed team is essential for the smooth  operations of the company.

 

 

 

 

Fail-safe mode model which worked for many years without resulting in any high turn-over, loss in time and resources to retrain for new employment.

 

If you have analyzed the chart above and think that it might be suitable to learn more or give it a try, consider to chat up with us using “Contact us” form or even head to the “e-shop” to learn more. We look forward to supporting your initiatives and thanks for your time in reading about this. Do share with your peers who might be in need of this and TRC would be pleased to offer a small token of appreciation for any successful sign-up.

This is a rather short article to share about the definition and published list of borderline medical device that might be supportive for your regulatory intelligence exercise.

A borderline medical device might have some features of a medical device which is to diagnose ,treat or prevent a symptoms or diseases  and possibly  contain  agent or even mode of action which achieve its intended function via   pharmacological, immunological or metabolic means. A common product would be that of a wart product which is to get rid of warts through cryotherapy.  The mode of action of the wart product could put it at risk of being a drug product rather than a medical device if it contains a caustic agent that destroy warts by chemical coagulation of protein . Hence it is useful for us to know  the rule defined by the authority in order for us to classify the product appropriately as medical device.

Definition of medical device in accordance to ASEAN Medical Device Directive:

A “medical device” shall mean any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article: (i) intended by the product owner to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: (a) diagnosis, prevention, monitoring, treatment or alleviation of disease; (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (c) investigation, replacement, modification, or support of the anatomy or of a physiological process; (d) supporting or sustaining life; (e) control of conception; (f) disinfection of medical devices; and (g) providing information for medical or diagnostic purposes by means of invitro examination of specimens derived from the human body; which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

Definition of borderline medical device as agreed by the ASEAN Medical Device Committee (AMDC):

In accordance to published guidance document by Medical Device Authority of Malaysia,

Borderline medical devices are devices that are difficult to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal protective equipment. These products are called borderline products until their status of medical device or non-medical device .

The list of borderline medical devices is updated yearly based on decision by the ASEAN Medical Device Committee (AMDC).

Useful references for you to check:

  1. ASEAN Medical Device Directives
  2. PRELIMINARY LIST OF BORDERLINE/ MD OR NON MD CLASIFICATION OF MEDICAL DEVICE
  3. List of Harmonized Classification of Devices
  4. HARMONISED BORDERLINE PRODUCTS IN ASEAN

 

If your product does is not listed within the list, you can always write in to us to get a confirmatory response regarding the classification with local authority.

 

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.