We’re back for our weekly deep dive into the fascinating world of regulatory affairs! This week, I want to tackle a topic that comes up surprisingly often in my conversations with clients, especially those looking to bring life-saving products like vaccines to new markets: How do you leverage a WHO Prequalified (PQ) dossier for registration in Singapore?

Many assume a WHO PQ means a straight shot, but as we as seasoned regulatory people know, it’s rarely that simple. While WHO Prequalification is an incredible achievement and a powerful foundation, there are always those crucial local nuances that need expert navigation.

What Exactly is a WHO Prequalified Dossier?

The World Health Organization (WHO) Prequalification program is a global initiative designed to ensure that key health products meet international standards of quality, safety, and efficacy. Think of it as a stamp of global assurance. WHO conducts a rigorous assessment, scrutinizing everything from the product’s quality data to the manufacturing site’s Good Manufacturing Practice (GMP) compliance. It’s a comprehensive review aimed at facilitating access to essential, quality-assured medical products, particularly for procurement by UN agencies and other international bodies.

What Kinds of Products Fall Under WHO PQ?

Initially, the program focused heavily on medicines for HIV/AIDS, TB, and malaria. Over time, it has expanded significantly. Today, WHO Prequalification covers a broad spectrum of products vital for global health, including:

• Medicines (Finished Pharmaceutical Products and Active Pharmaceutical Ingredients): Especially generics and essential medicines.
• Vaccines: This is a huge one! Ensuring vaccine quality and efficacy for global immunization programs is a cornerstone of WHO PQ.
• In Vitro Diagnostics (IVDs): Products used for detecting diseases.
• Immunization Devices: Like syringes and safety boxes.
• Vector Control Products: Tools to fight vector-borne diseases.

Based on experiences and inquiries, vaccines are often the first product that comes to mind when leveraging WHO PQ. The principles, however, apply broadly across these categories.

Advantages of a WHO PQ Dossier

The advantages are:

• A Global Seal of Quality: A WHO PQ product has already undergone a thorough evaluation by a globally respected authority. This immediately instills confidence in national regulatory agencies (NRAs) about the product’s quality, safety, and efficacy profile.
• Streamlined Initial Review: For many NRAs, especially those with limited resources, a WHO PQ can significantly streamline their initial assessment, as much of the heavy lifting on the core scientific data has already been done.
• Market Access and Procurement: For many manufacturers, WHO PQ is a prerequisite for supplying products to major international procurement bodies, opening up vast markets.
• Robust Scientific and Quality Foundation: The WHO Prequalified dossier provides a comprehensive, pre-vetted scientific and quality package (often in CTD format). This means the core technical data, which is typically the most time-consuming to generate and compile, is largely established, significantly reducing the burden of its “major overhaul” when preparing for national submissions.

Bridging the Gap for Singapore Submission

Here are the key gaps we typically need to bridge:

• Local Administrative & Legal Requirements (Module 1): The WHO PQ dossier, while often following the CTD structure, will have a WHO-specific Module 1. HSA, like any national authority, has its own unique Module 1 requirements. This includes specific application forms, declarations, appointment of a local company/agent (which, surprise, surprise, is a must!), and adherence to local legal frameworks.
• Singapore-Specific Labelling & Package Inserts: Even if the core data is accepted, the product information (labels, package inserts, patient information leaflets) must be fully compliant with HSA’s detailed requirements for language, content, and format. This isn’t just a translation job; it’s a regulatory art form!
• Good Manufacturing Practice (GMP) Conformity: While WHO conducts GMP inspections for PQ, HSA recognizes PIC/S GMP as the standard. Based on recognition agreements and internal evaluation, manufacturing sites can either be subjected to a GMP DEVA assessment or an overseas inspection.
• Risk Management Plan (RMP): HSA requires a comprehensive Risk Management Plan, along with a Singapore-Specific Annex (SSA), to be submitted as part of the registration application for therapeutic products, including vaccines.
• Vaccine-Specific Lot Release: This is a crucial point for vaccines! Even after registration, all imported registered vaccines require a notification to HSA on lot release information before they can be supplied in Singapore. This is a critical post-registration compliance step.
• Dossier Format Alignment (ICH CTD/ACTD): While WHO PQ is increasingly aligned with CTD, HSA accepts both ICH CTD and ASEAN Common Technical Dossier (ACTD) formats. There can be subtle but important differences in how information is presented or what specific details are required within certain sections, especially if the ACTD format is chosen or if there are specific HSA guidance documents that refine the CTD expectations.

Essentially, a WHO PQ dossier gives you a solid scientific and quality foundation in which “a major overhaul” is essentially avoided when preparing for local submission.

How TRC Can Support Your Journey

TRC specializes in taking WHO Prequalified dossier and meticulously transforming it into a complete, compliant submission for HSA.

We don’t just translate documents; we understand the intent behind HSA’s guidelines and the specific nuances of what they’re looking for. From managing the intricate Module 1 administrative requirements, ensuring all labelling is compliant, to advising on GMP assessments and navigating the vaccine-specific lot release process – we cover all the bases.

Our “on-the-ground” practical experience in Singapore regulatory affairs means we can foresee potential roadblocks and proactively address them, streamlining your path to market. We work like an extension of your own team, guiding you through every step, ensuring that your life-saving vaccines, or any other WHO Prequalified product, reach the patients who need them, right here in Singapore.

Ready to make your WHO PQ a launchpad for Singapore market access? Let’s talk!

Biologics submissions are often more complex than small molecule applications, not just due to the science but because of the higher regulatory scrutiny involved. In Singapore, HSA’s review of biologics focuses heavily on product quality, clinical safety, and manufacturing consistency.

At TRC, we’ve supported multiple clients preparing or refining their Common Technical Document (CTD) dossiers for biologic products. Here are some of the most common issues we’ve encountered — either flagged during internal quality checks or in regulatory feedback from HSA:

1. Incomplete Viral Safety Data

Biologics derived from cell lines or involving human/animal raw materials must include robust viral clearance studies and testing for adventitious agents. Missing or insufficient viral validation summaries can delay review significantly. Applicants should ensure that viral reduction steps are well justified and validated.

2. Gaps in Comparability Data

When there are changes in manufacturing processes, comparability studies are essential to show that the pre- and post-change product remains equivalent in quality and efficacy. This is a frequent sticking point, especially for companies with foreign data relying on prior regulatory approvals. HSA expects a clear and data-driven comparability package — not just a reference to EMA or FDA acceptance.

3. Inadequate Characterization of Cell Banks

Master Cell Bank (MCB) and Working Cell Bank (WCB) characterization should be detailed and compliant with ICH Q5D/Q5B. Some applicants overlook genetic stability data or omit full sterility and purity test reports — items that HSA considers critical.

4. Lack of Clear Endotoxin and Sterility Validation

For injectable biologics, sterility and endotoxin testing methods must be fully validated and described in Module 3. In some cases, clients assume that referencing a compendial method is enough — but validation under actual product conditions (matrix effect, interference) must still be demonstrated.

5. Container Closure Integrity Not Adequately Demonstrated

Especially for prefilled syringes or vials, HSA may request evidence of container closure integrity (CCI) testing, particularly under worst-case shipping or storage conditions. CCI studies should be product-specific and reflect real-world usage, not just generic studies.

Biologics submissions are resource-intensive — but a strong CTD package reduces review time and prevents unnecessary back-and-forth with the authority. At TRC, we support clients in spotting and addressing these issues early, so they don’t become stumbling blocks down the road.

If your team is preparing a biologics application for the Singapore market and would like a second pair of eyes on your dossier, feel free to reach out.

When companies prepare to register biologic products in Singapore, there’s a common assumption that all biologics must go through the NDA-1 route. But that’s not always the case.

Understanding Singapore’s NDA-1, NDA-2, and NDA-3 categories — and which applies to your product — is key to smooth regulatory submissions and avoiding unexpected delays.

NDA-1: New Biological Active Substance
Under HSA’s framework, NDA-1 applies when the product contains a new chemical or biological active substance that has never been registered in Singapore. This typically includes:

• Innovative biologics

• First-in-class monoclonal antibodies

• New gene or cell therapy products

• Novel vaccines

These applications require full safety, efficacy, and quality data, and undergo a thorough scientific review, often with longer evaluation timelines.

NDA-2: New Dosage Form, Strength, Route, or Formulation
NDA-2 covers new dosage forms, strengths, administration routes, or formulations of an already-registered active substance. Examples include:

• A subcutaneous version of an approved IV monoclonal antibody

• A prefilled syringe instead of a vial

• A biosimilar referencing a biologic already registered in Singapore

Many biosimilars fall under NDA-2 when referencing a Singapore-registered originator. This means no new active substance is introduced, but bridging and comparative studies (analytical, PK/PD, sometimes clinical) are required. If the reference product isn’t registered locally, the biosimilar may be up-classified to NDA-1.

NDA-3: Subsequent Strength(s) of Registered Product
NDA-3 applies to additional strengths of products already registered or submitted as NDA-1 or NDA-2. The new strength must have the same product name, active ingredient, dosage form, presentation, indication, dosing regimen, and patient population as the original.
Examples include introducing a 50 mg vial after registering a 25 mg vial of the same biologic. Data requirements are usually limited to bridging information.

Why is this important?
Misclassifying your NDA category can cause delays, extra data requests, or even rejection at screening. Knowing the right NDA pathway helps you plan better and work smoothly with HSA.

Navigating Singapore’s regulatory pathways takes experience and understanding of local requirements. Whether you’re registering an innovative biologic, a biosimilar, or new strengths and formulations, it’s important to:

• Accurately classify your NDA category

• Understand HSA’s data and documentation expectations

• Strategically plan your submission for efficiency

As a regulatory consultant, I work closely with clients to simplify these complexities and help prepare submissions that meet HSA requirements. Feel free to reach out if you need support. Wishing you all the best in your regulatory journey!

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

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

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

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

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

Benefit #2: Oversee Regulatory Affairs

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

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

Benefit #3: Comprehensive Compliance Support

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

Benefit #4: Cost-Effective

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

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

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

Traditional Chinese Medicine (TCM) requires strict regulatory adherence in Singapore, with the practice heavily regulated by the Traditional Chinese Medicine Practitioners Board (TCMPB) under the Ministry of Health (MOH). To practise TCM legally in Singapore, practitioners must be registered with the TCMPB and hold a valid practising certificate.

The stringent scrutiny in terms of licensing, premise requirements, and adherence to good clinical practices also extends to all TCM clinics and healthcare establishments, with the MOH conducting regular inspections and audits to ensure every premise complies with these strict regulations. 

In addition, Chinese Proprietary Medicines (CPM) – i.e. medicinal products used according to the traditional Chinese medicine (TCM) system of treatment that are manufactured into finished dosage forms (for example, tablets, capsules, pills) – are governed by The Health Sciences Authority (HSA) and must comply with a set of safety and quality criteria before they are made available to the public in Singapore.

So, as you can see, those wishing to practise TCM or enter the CPM industry must navigate a complex tapestry of requirements to ensure everything is above board and their business complies with regulations set out by Singapore’s health authorities. Therefore, it is unsurprising that many turn to a regulatory affairs service for help. If you are in a similar boat, let us help you better understand the situation by sharing a regulatory overview of TCM in Singapore.

Read More: Navigating Regulatory Changes in Singapore’s Healthcare Industry

How is Traditional Chinese Medicine regulated in Singapore?

Presently, TCM clinics need not register with MOH. However, they are still subjected to scrutiny by MOH to ensure they comply with good clinical practices. Meanwhile, any professional who wishes to practise TCM in Singapore must be registered with the TCMPB and hold a valid practising certificate issued by the Board, which regulates the professional conduct and ethics of registered TCM practitioners.

If you wish to start a TCM practice and want to learn more about the comprehensive regulations, we recommend consulting a regulatory service provider to ensure full compliance.

How is Chinese Proprietary Medicines regulated in Singapore?

To ensure the safety and quality of CPM in Singapore, all local CPM dealers, including importers, manufacturers, re-packers, and wholesalers, must be licensed by HSA. These businesses must also apply for product listing approval for each CPM before importing, manufacturing, or selling the item in Singapore.

Needless to say, the process to get the products successfully listed with HSA is stringent, as dealers must meet relevant safety and quality requirements for their CPM. 

The products must not contain:

• Any potent/toxic substances controlled under the Poisons Act
• Any artificial chemical compounds found in Western medicines
• Excessive levels of toxic heavy metals like arsenic, lead, and mercury and microbial contamination

 

Additionally, all CPM products must have English labels with the following:

• Product Name
• Batch Number
• Expiry Date
• Active ingredients
• Dosage

 

Dealers are also not allowed to make claims for treating a specified list of severe medication conditions, such as diabetes and cancer, on their product labels. If the business is made aware of an adverse event, it must report the incident to HSA immediately.

After the CPM product is made available to the public, there is a post-market surveillance programme implemented to observe the safety of the medicines. 

Monitoring Process

• Firstly, a risk-based market surveillance programme is conducted to sample and test products found in the market. 
• Secondly, an adverse reaction surveillance programme draws on HSA’s network of local healthcare professionals and international regulatory partners to identify any medicines that may potentially cause adverse reactions. 

 

This system of checks and controls ensures that HSA is able to initiate timely recalls of harmful or defective products.

If you wish to learn how you can successfully navigate the complex regulatory requirements in the CPM industry, we recommend seeking the advice of an expert regulatory affairs management team.

The TCM regulatory landscape in Singapore underscores the nation’s commitment to professionalism, integrity, and patient safety. Every aspect, from practitioner qualifications to product quality control, is meticulously controlled to uphold standards of excellence and ethical conduct.

However, navigating this labyrinthine landscape need not be complex and confusing when you work with the correct regulatory affairs service. As a regulatory service provider with a wealth of experience assisting local and global pharmaceutical and medical companies, we are well-placed to answer any regulatory query you have about the industry. Contact us to schedule an appointment with our regulatory affairs management team today!

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

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

1. Stay informed through official sources

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

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

2. Leverage industry associations and professional networks

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

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

3. Develop robust internal processes

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

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

4. Regularly assess compliance and identify gaps

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

5. Consult legal and regulatory experts

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

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

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

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

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

TRC shall share a short summary on what RPA means :

Review

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

Plan

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

Act

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

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

 

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

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

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

Below are 5 tips to share on regulatory project management:

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

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

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

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

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

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

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

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

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

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

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

 

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

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

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

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