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

1. Quality of the CMC documents- Drug Substance

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

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

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

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

 2. Quality of the CMC documents- Drug Product

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

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

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

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

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

3. Clinical efficacy

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

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

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

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

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

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

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

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

     

     

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

     

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

     

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

     

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

     

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

     

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

     

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

     

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

    As pharmaceutical products directly impact patient health and well-being, maintaining high-quality standards is essential. Medications should always be safe, effective and consistent in their therapeutic effects to avoid potential risks such as treatment failures, adverse reactions or even life-threatening consequences. 

    This is where Good Distribution Practice (GDP) for pharmaceutical products comes in handy, guaranteeing the quality and integrity of medicinal solutions as they move through the supply chain from manufacturer to end-user. It encompasses a set of guidelines, involving practices and procedures aimed at maintaining appropriate storage, transportation and handling conditions to prevent compromising the safety, efficacy or quality of the products. In this article, we take a look at how pharmaceutical organisations can ensure GDP to uphold their reputation and build greater trust with their customers.

    Good Pharma Registration 

    While good pharma registration focuses on the initial assessment of a product’s suitability for market entry, it still influences GDP by establishing standards and requirements that products must meet throughout their lifecycle. As such, a comprehensive understanding of a product’s characteristics gained during registration, including stability profiles and storage requirements, is essential when it comes to the formulation of distribution protocols. These protocols ensure the maintenance of product integrity during transportation, warehousing and handling. For instance, if a medication is found to be sensitive to temperature fluctuations during the registration process, specific storage and transportation requirements may be mandated to safeguard the product’s effectiveness and safety for patient use.

    Learn more: Top 6 Tips for Successful Pharma Registration in Singapore

    At The Reg Consultants, we understand the importance of proper pharma registration in the ASEAN region for market approval and distribution. Our subscription plans for regulatory affairs are specially designed to help you streamline the registration process and comply with regional regulations.  

    Quality Management System

    QMS for Pharma

    A Quality Management System (QMS) in the pharmaceutical industry is an all-encompassing framework comprising processes and resources covering document control, risk management, change control, and validation protocols. GDP requires the implementation of a robust QMS to ensure all aspects of distribution operations adhere to established standards and procedures. A QMS helps to identify, assess and mitigate risks associated with product handling, storage, transportation and documentation, playing a pivotal role in maintaining product integrity and regulatory compliance. Regular audits, inspections, and performance evaluations are also integral components of the QMS, enabling ongoing verification of GDP adherence and identification of areas for enhancement. Additionally, training programmes embedded within the QMS equip personnel with the knowledge and skills necessary to execute their roles in accordance with GDP guidelines. 

    However, setting up your QMS documentation can be tedious and time-consuming, which is why enlisting the help of professionals is always recommended. Our regulatory consulting services include QMS documentation set-up, making it easier for your products to gain regulatory approval and achieve the highest industry standards. 

    Post-Licensing Activities

    Though the majority of pharmaceutical organisations may dedicate more of their time and effort to the initial stages of gaining product distribution approval, post-licensing activities are equally crucial. These activities make sure that products continue to meet regulatory standards, safeguarding product integrity. Post-licensing activities like renewals, variations, change notifications and market recall activities directly impact GDP by influencing the regulatory status, documentation, handling procedures and distribution protocols of pharmaceutical products. For example, renewals and variations require thorough documentation and adherence to regulatory requirements, which contribute to the proper management of distribution operations. Change notifications help maintain transparency and accountability in the distribution process, appropriately communicating and addressing any changes affecting product quality or safety. Similarly, market recall activities are essential for mitigating risks to patient safety and upholding the integrity of the supply chain. 

    With expertise in regulatory consulting for pharma, The Reg Consultants is here to support you across all touchpoints of your distribution journey even after successful market entry. Our post-licensing services include renewal, variations, change notifications, and market recall activities, assuring your products remain compliant with evolving laws and guidelines.

    An indispensable tool in the world of pharmaceutics, GDP serves as a useful structure to safeguard patient health and well-being. Leverage the above tips to maintain product quality and efficacy, from production to consumption, for seamless market access in your next pharma distribution venture!

    The Reg Consultants specialises in pharma regulatory services. We prioritise the safety of each pharmaceutical product, ensuring compliance with Good Distribution Practices (GDP), ISO 13485, and ISO 9001 requirements. Contact us today for more information

    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

    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

    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

    Comprehensive Compliance Suppor

    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

    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 TCM regulated in Singapore?

    Clinical Practices

    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 CPM regulated in Singapore?

    The Safety and Quality of CPM 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. For instance, businesses must ensure that their products do 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.

    In addition, all CPM products must feature English labels highlighting essential information, including product name, batch number, expiry date, active ingredients, and 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. The monitoring process consists of two components.

    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!

    Flags of ASEAN countries.

    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

     

    As a country facing an ageing population and a growing incidence of chronic diseases, it is unsurprising that various pharmaceutical businesses seek to make their products available in Singapore to meet the increasing demand for advanced medical treatments.

    However, the selling of new pharmaceutical products is heavily regulated in Singapore and is only permitted after a valid product license has been obtained through registration with the Health Sciences Authority (HSA). Such stringent regulations are in place to ensure the product is safe for consumption by the public.

    For pharmaceutical companies planning to introduce their products into Singapore’s market, navigating the regulatory landscape seamlessly and ensuring compliance with the HSA’s requirements are paramount. Fortunately, the entire process need not be complicated. Let us share six essential tips to ensure a smooth and successful pharma registration in Singapore.

    Tip #1: Familiarise yourself with the regulatory requirements in Singapore

    A man facing a laptop

    When you fail to plan, you plan to fail. Without adequate knowledge of the registration process and an intimate understanding of the HSA’s regulatory requirements, you are only setting yourself up for failure.

    So, thoroughly study the HSA’s guidelines pertaining to pharmaceutical product registration beforehand, encompassing everything from product safety to manufacturing processes. Familiarising yourself with the regulations provides a robust foundation, allowing you to tailor your submission to meet all requirements, thus ensuring a successful registration.

    Tip #2: Compile a comprehensive registration dossier

    Your registration dossier serves as the foundation of your application to the HSA. Every information contained within the dossier will be scrutinised to ensure your product complies with existing regulations. Any omission of relevant data could compromise your entire pharma registration effort. So, ensure your submission is complete with all relevant information about your product, including its composition, efficacy data, manufacturing processes, and safety profiles.

    Tip #3: Engage the help of a local regulatory consultant

    Image of 2 women discussing

    Navigating the medical regulatory landscape can be complex even for a pharmaceutical company based in Singapore, let alone foreign businesses from a different market. If you are unsure where to begin, leveraging the expertise of a consultant with experience in the local regulatory scene can prove invaluable.

    A reliable pharmaceutical regulatory consulting firm can provide helpful insights and guide you through the various intricacies of the administrative process, ensuring your application aligns seamlessly with the HSA’s guidelines, thus boosting your chances of success.

    Tip #4: Understand your product classification

    Pharmaceutical products in Singapore are classified into several categories based on their intended use, risk level, and mode of action. The HSA’s classification system is as below:

    • Complimentary Health Product (CPM) “Health supplements”
    • Therapeutic Products covering chemical drugs, biotechnology products, blood products, biosimilars
    • Medical devices (Risk Class A, B,C and D)
    • Chinese Proprietary Medicine (CPM)
    • Cell Gene Therapy Product (Class 1 or Class 2)

     

    Each class is governed by distinct regulatory requirements. So, understanding this classification system and which category your pharmaceutical product belongs to is paramount. Accurate classification ensures you follow the appropriate guidelines, streamlining the pharma registration process and preventing your application from being dismissed on a technicality.

    Learn More: Misconception of regulatory classification of medical products

    Tip #5: Clinical trials

    Conduct clinical trials

    HSA often requires robust clinical evidence to support registration applications. Overseas clinical trial data are accepted for registration which saves the hassle of conducting local trials. Also, engaging the help of a local regulatory consultancy firm to analyse the clinical documentation could cement your compliance to the local requirements pertaining to the safety and efficacy of your pharmaceutical product. This ensures compliance with HSA guidelines.

    Tip #6: Ensure compliance and good practice

    HSA governs more than the safety and manufacturing process of a pharmaceutical product. Its labelling and packaging must also comply with the HSA’s good manufacturing practice (GMP) standards and quality control.

    So, prepare detailed documentation and evidence, such as inspection reports, certificates, and quality control processes, showcasing adherence to the GMP standards. This diligence can help expedite the pharma registration process and establish a foundation for long-term compliance.

    Ultimately, a thorough and well-executed registration strategy requires meticulous planning, strict adherence to regulatory guidelines, and a keen understanding of the local regulatory landscape. With these elements in place, you can set the stage for a successful market entry and ensure sustained success in Singapore.

    If you require assistance with your product registration, look no further than The Reg Consultants for your pharmaceutical regulatory consulting needs. With a wealth of experience in assisting pharmaceutical and medical companies, both local and overseas, we can aid your business in streamlining the product registration process and securing the necessary approvals for marketing and distribution within the ASEAN region. Contact us today to learn how we can help.

    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 .

    Key visual of regulatory submissions.

    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.