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.

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.

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”
  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 in the few 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 cosmetic in Singapore, we need to perform the following steps:

    1. 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 that is intended to be placed in contact with the various external parts of the human body or with the teeth or the mucous membranes of the oral cavity with a view exclusively or mainly to:

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

    Example of products that are not cosmetics:  oral supplements for beauty purposes, injections/injectable products, massage and essential oil, aesthetic/beauty devices, lubricants, insect repellents, sanitary pads, hand sanitizers, cream for treatment of acne/eczema/psoriasis, toothbrush, dental floss, detergent, temporary tattoo fake eye lashes, nail stickers and LED light used in dental kit (whitening gel is a cosmetic).

    1. 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 function as it is claimed.
    • Labelling of cosmetics should contains 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 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 appropriate assigned based on the key ingredient function, target site of application and physiological effects of cosmetics.  Some examples of claims that can be accepted accordance to ASEAN Cosmetic Claims Guide are presented below:
    Product Type Claims
    Hair care product Eliminates dandruff permanently  Restores hair cells

    Hair loss can be arrested or reversed Stimulates hair growth

    Skin products Prevents, reduces or reverses the physiological changes and degeneration conditions brought about by aging

    Removes scars

    Numbing effect

    Prevents, heals, treats or stops acne Treatment of cellulite

     Lose centimetres

    Reduces/controls swelling/oedema Removes/burns fat

    Fungicidal action

    Virucidal action

    Oral or dental hygiene products Treatment or prevention of dental abscess, gumboils, inflammation, mouth ulcers, periodontitis, pyorrhoea, periodontal disease, stomatitis, thrush or any oral diseases or infections

    Whitens tetracycline-induced stains

     

    • Quality of the product- In order to ensure that the product manufacturer meets with international requirements, it would be appropriate to ensure that the manufacturing facilities have relevant certification that complies with GMP or ISO standard 22716:2007 ,perform local testing if required to check for heavy metals and microbiological content, as well as 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  in skincare cosmetic products. The inappropriate use of hydroquinone could result in changes in skin colour and hypersensitivity reactions such as rashes, redness, tingling and burning of skin. Tretinoin could lead to redness and peeling of the skin and should only be used under medical supervision.

     

    1. Cosmetic notification should be performed by appointed companies that are intending to import or sell the cosmetic products in the market.  As cosmetic products are not evaluated by the authority, it is important for importers to be responsible for the safety and quality of the product.  There are 3 main things that should be maintained on site for the importer namely:
    • Product Information File which contains all the quality and safety records of the cosmetics to comply to the relevant standards. It should be kept to update in accordance to what is happening over at the manufacturing end that could have an impact on your product.
    • Records of cosmetic supply to the market- It should be maintained for 2 years in accordance to the Guidelines on the Control of Cosmetics. The record should contain the name and notification number of the product, name and address of company supplied, and the batch number, date and quantity of 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 7 days for adverse events that result in death or life threatening and 15 days for adverse events that results in hospitalisation or any persistent or significant disability or incapacity.

     

    To end off the article, we are sharing some useful links for you to kick start the process:

    1. Guidelines on the Control of Cosmetic Products
    2. ASEAN Cosmetic Directive
    3. Overview on 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 is meeting the local requirements, feel free to be in touch or share it with your peers who might need them.

    health supplement registration in Singapore

    At the current moment, Health Supplements are not subjected to registration prior to importation. Notification is on a voluntary basis. There may be advantage for you to execute the notification of the health supplements from a commercial perspective and it is always to be pro-active to adapt to the existing regulations rather than to rush frantically to submit when announcement is made officially.

    We share some key points to note for importing health supplements:

    1. We need to be sure that your product falls under the category of health supplement. In order to fulfill the definition of Health Supplement in the local context , assess the below question :
    2. Is your product used to supplement a diet, maintain, enhance and improve the healthy functions of the human body?
    3. Does your product contain one or more of the following or combination of the ingredients:
    4. Vitamins, minerals, amino acid, fatty acids, enzymes, probiotics, and other bioactive substances;
    5. Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates; and
    • Synthetic sources of ingredients mentioned in (i) and (ii).
    1. Your product dosage form should not be an injectable or eye drop.

     

    1. From safety and quality perspective, we need to ensure that the health supplement does not contain negative list of substances and meet the limits allowable for vitamins and minerals, heavy toxic metal, and microbial limits. The product is manufactured to a consistent quality meeting release requirements for specific dosage form and is stable throughout the proposed shelf life.  Please refer to below table for quick reference on the links for your compliance exercise :
    Checklist Links:
    Check for negative list of substances ASEAN-Guiding-Principles-for-Negative-List-HS-V4.0
    Heavy metal limits

     

    Arsenic  5 parts per million

    Cadmium  0.3ppm

    Lead        10ppm

    Mercury  0.5ppm

    Microbial limits ASEAN Guidelines on Limits of Contaminants for Health Supplements
    TSE checklist ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Health Supplements
    Vitamins and Mineral Limits ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements
    Quality Standards Physical test parameters based on dosage forms

    Testing requirements

    Manufacturing standards

    Labelling Standards Guideline for labelling standards
    Stability and Shelf Life ASEAN Guidelines on Stability and Shelf-Life of Health Supplements

     

    1. Health supplement claims must not be labelled , advertised or promoted for treatment or prevention of any disease or related conditions. There are some general principles which we can follow:
    • We need to ensure that the claim is truthful and is simple to understand.
    • We need to ensure the claim is well substantiated from good-quality scientific evidence from human studies.
    • There should not be testimonials from health professionals .
    • Testimonials from individual must be genuine and validated with real person information.
    • The claims cannot exploit fear or discourage from medical advice.
    • There should be no reference to performance in studies ,anti-aging, sexual function and relationships , consumption, hormonal levels, blood sugar levels, claims of safety.
    • Refrain from using scientific data that the public cannot comprehend to exaggerate the efficacy of the product.
    • The advertising of the product should comply with Singapore Code of Advertising Practice (SCAP).

          Below are references to consider before affixing claims to your health supplement:

    1. List of Health Claims
    2. Claims substantiation Guidelines

     

    We hope the above has been useful for you for importation of health supplements into Singapore. Share it with your peers who might need them!

     

    generic drug registration in Singapore

    A generic product must have the same qualitative and quantitative composition in active ingredients and be of the same pharmaceutical form as a currently registered product in Singapore and shown to be bioequivalent to Singapore Reference Product (SRP). A marketing authorization application for a generic product fall under the application category of GDA-1 and GDA-2 in which the former represents strength of a registered chemical entity and usually also deemed as the one in which bioequivalence studies is conducted on and the latter is for any subsequent strength.  If a generic product is not registered in any regulatory agency, the application cannot be submitted.

    Whilst preparing several generic applications for companies we noted the following common challenges faced when assessment of dossier:

    1. Administrative :
    • Certificate of Pharmaceutical Product(CPP) which does not state Singapore is importing country.
    • Letter of Authorization which has outdated company’s name and inconsistent manufacturing address not tallied with GMP certificate.

    2. Bioequivalence:

    • Acceptance of BE reference product : No additional comparative dissolution studies was conducted between BE reference product and Singapore Reference Product to demonstrate similarity profile as most of the BE reference product is from a different manufacturing source as that registered in Singapore.
    • Biowaiver of subsequent strength – Unable to fulfil requirements such as dose proportionality in order to waive off the bioequivalence studies.
    • Acceptance of a bioequivalence studies- BE Studies conducted according to other countries guidelines and not taking into consideration SRP’s package insert dosing regimen and any additional studies required such as a multi-dose study.
    1. Presence of ZoneIVb stability studies: ZoneIVb stability data is not available based on the number of minimum batches required for submission or from the different sites.
    2. Patent check : Insufficient support obtained to determine the right category of patent application.

    Sharing some pointers that might help you to get prepared for your filing in Singapore :

    1. Administrative:
    •   Ensure that CPP applied reflects Singapore as the importing country.
    •   Letter of Authorization issued reflects the correct name ( following format of : Proprietary Name Dosage Form Strength Standard (optional) ,valid company’s name and addresses which is consistent with GMP certificate. 

    2.Bioequivalence:

    3. ZoneIVb stability studies:

    Critical dosage form:  3 batches with minimum  of 12 months data based on ZoneIVb condition( 30°C/75%RH) and 6 months data based on accelerated storage condition (40°C/75%RH)  

    Non-critical dosage form:  2 batches with minimum of 6 months data based on ZoneIVb condition (30°C/75%RH) and 6 months based on accelerated storage condition (40°C/75%RH)

    1. Patent check:

    Engage the support of your manufacturer’s legal team or your own legal team  to perform due diligence check regarding the patent status of the product in Singapore.  Patent check is important for generic applications as it might impact upon the progress of your applications and for determine whether submission is allowable.

    We hope that the above are useful for you. If there are any needs to support your generic drugs submission feel free to reach out to TRC.

    Responsibilities of a Marketing Authorization Holder (MAH)

    A Marketing Authorization Holder (MAH) is a local company that is assigned by the Principal /Manufacturer as the responsible party to be in charge of all registration and licensing matters pertaining to the right to distribute the pharmaceutical or medical products in the market. As a Marketing Authorization Holder, the common responsibilities are set out as below and is a non-exhaustive list :

    1. Maintenance of the product licenses issued by the Health Authority which includes renewal, performing quality and safety updates to the dossier submitted to the authority and responsive to the Health Authority queries concerning the products
    2. Pharmacovigilance responsibilities like Adverse Event Reporting, Batch Recall Activities, Safety Signals Alert , Literature review and safety report update if required.
    3. Performing due-diligence activities such as internal audit, annual product review exercise by the Principals, regulatory intelligence activities to ensure that the rights to market the product would not be jeopardized by any non-compliance both locally and to the Principal.

    A Marketing Authorization Holder can be either a local distributor or an independent license holder such as TRC. It is observed recently that  established distributor firms are more selective towards the principals that they want to work with depending on the nature of the product and the profit that could be generated if the portfolio is taken up. From the Principal’s perspective, it could delay product launches if a suitable distributor firm could not be found or  even a potential disruption in supply and  non-compliance issues for products that are already in the market. For assigned local distributor who have multiple product lines with different principals, it could be hard to manage at times due to lack of internal resources such as  “untimely “requests that are introduced all at once such as : internal audit , multiple variations to be introduced for multiple products such as artwork change , addition of site that could affect product supply in the market especially if they are tied up with tender season.

    It could be handy  to consider having an alternative  support be it from a distributor’s end or Principal’s end to engage an Independent License Holder or Regulatory Consultant  to  alleviate this stress to  perform the work required to get the situation moving.

    TRC has launched a subscription plan that could :

    • Reduce your time in looking for a suitable staff
    • Reduce internal resources and time to train before the work can be performed
    • Allows you to leverage and utilize experienced local regulatory expertise to perform the work for you based on your objectives within the set timeframe within plan you purchased
    • Eliminate the worry of rising cost in utilizing outsourced support with capped hours.

    If you think that it would be worthwhile to understand more about the plan, please check out the link.

    Thank you!