Topics The 2nd Japan-Malaysia Symposium was held
The 2nd Japan-Malaysia Symposium was held on July 14, 2022, hosted by the National Pharmaceuticals Regulatory Agency (NPRA) of Malaysia and the Pharmaceuticals and Medical Devices Agency (PMDA). The symposium was held in an online format. The symposium aimed to deepen mutual understanding of pharmaceutical affairs between Japan and Malaysia to form the basis for cooperation in drug regulation and development in both countries.
Symposium Participants
In addition to keynote speeches, the symposium featured sharing and discussion of the latest information on pharmaceutical regulations in both countries, including expedited approval systems, non-clinical studies of regenerative medicine products, E-Labeling, and pharmacovigilance (PV) for vaccines against novel coronavirus infection (COVID-19).
From Japan, Yasuhiro Fujiwara, President of PMDA, PMDA, MHLW, and member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) attended the symposium, while from Malaysia, Roshayati Mohamad Sani, Director of NPRA, and nearly 400 participants from NPRA and Malaysian industry attended this symposium. The keynote speech was delivered by Mr. Roshayati Mohamad Sani, Director of NPRA.
In the keynote speech, Dr. Roshayati Mohamad Sani of NPRA gave a presentation on regulatory measures in Malaysia during the COVID-19 pandemic, regulatory harmonization within the Association of Southeast Asian Nations (ASEAN), and cooperation between Japan and Malaysia on pharmaceutical regulatory issues. cooperation between Japan and Malaysia on pharmaceutical regulations. From the Japanese side, PMDA President Fujiwara spoke about the promotion of the clinical development ecosystem and international cooperation in the International Cooperation of Medicinal Regulatory Authorities (ICMRA) and the PMDA Asian Training Center (PMDA-ATC).
The following article introduces the Malaysian side of the presentations.
Expedited Review
Mr. Azizah Ab. Ghani, Head of Biologics Section, Centre of Product & Cosmetic Evaluation, NPRA
Mr. Ramli explained about the ASEAN Joint Assessment (JRA), a joint assessment scheme among ASEAN member countries, which allows simultaneous applications to be submitted to multiple countries. Under the Joint Assessment scheme, applicants submit applications simultaneously to the countries in ASEAN where they wish to apply, and National Regulatory Authorities (NRAs) from at least three countries participate in the assessment, which is conducted jointly by each NRA. Upon completion of the evaluation, a joint evaluation report will be issued and each NRA will make a decision on whether or not to approve the application individually based on the report. Uploading of application materials, online review and issuing of inquiries will be done through a common platform, and we are currently in the process of establishing appropriate administrative and IT tools and platforms. In addition, he explained the existing expedited review system in Malaysia, which includes priority review, simplified review, and an expedited review system for disasters such as pandemics.
Sharing experiences and challenges on E-Labeling
Ms. Rosliza Lajis, Head of New Drug Product Section, National Pharmaceutical Regulatory Division, NPRA
In Malaysia, a joint industry-government task force has started to introduce E-Labeling in 2019. Rosliza explained that the future implementation of E-Labeling will require discussion and validation of platforms, implementation methods, accessibility in rural areas, costs, and product and code changes. Mr. Rosliza explained that future implementation of E-Labeling will require discussion and validation of platforms, implementation methods, accessibility in rural areas, costs, and product code changes. Full implementation of E-Labeling is not expected until 2024, and Malaysia aims to implement E-Labeling in a way that is acceptable to all stakeholders through careful validation. The full implementation of E-Labeling is not expected until 2024, and Malaysia is working to implement it in a way that is acceptable to all stakeholders, while carefully validating it.
Pharmacovigilance of COVID-19 vaccines
Ms. Azuana Ramli, Head of Pharmacovigilance Section, NPRA
He introduced the case of pharmacovigilance of COVID-19 vaccine. In Malaysia, COVID-19 vaccine is registered as conditionally approved, and close safety monitoring is in place as a post-approval requirement on PV. AEFI reports are compiled in a database and the frequency of adverse events for each vaccine is analyzed. AEFI reports are compiled into a database and the frequency of adverse events for each vaccine is analyzed and made publicly available. In Malaysia, the vaccine program is operated as a system that uses IT to catch the signals of vaccine safety information and disseminate them widely to the public.
Closing Remarks
Although the symposium was held online, we were able to hear very rich and meaningful discussions on the regulatory response under COVID-19, the ASEAN Joint Assessment, E-Labeling, etc. The COVID-19 pandemic has required regulators to modify their existing review methods, but the difficulties have made it difficult for regulators to respond. The COVID-19 pandemic has required the regulatory authorities to modify their previous screening methods, but the difficulties have led to more efficient and flexible methods. In addition, the fact that both Japan and Malaysia were able to promote mutual understanding of pharmaceutical regulations through this symposium will lead to international cooperation not only between Japan and Malaysia, but also between Japan and ASEAN as a whole. We feel that the symposium provided a good opportunity to bring innovative Japanese medicines to the people of Malaysia and ASEAN more quickly.
( Junichi Kihara, Malaysia Team, Asia Subcommittee, International Committee)