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 :
- 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.
- 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;
- c) products manufactured in a PIC/S-GMP compliant site
Process in brief
- Participating National Regulatory Authority(NRA) publish on their website in the form of a Notice : Notices of Invitation to Express Interest.
- Applicant can submit their interest by filling up the appropriate application form to the authority.
- Lead NRA seeks concurrence of participating NRAs for accepting Expression of Interest
- Lead NRA requests applicant to submit required documentation to participating NRAs.
- Assessment work is then carried out together by all participating NRAs and a joint assessment report is prepared
- 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:
- the technical application dossier must include the same technical information as that submitted to reference NRA or WHO-PQP;
- 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;
- c) administrative part of dossier specific to each participating NRA requirements will be submitted directly to each participating authority;
- 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.
- List of Priority Products
- Processing timelines
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
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
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 and alternative medicine (CAM)
- Conventional drugs
- Health supplements
- Medical devices
- Traditional Chinese Medicine (TCM)
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.
Tip #5: 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.