The 3rd Japan-Malaysia Symposium on Drug Regulation Active discussions were held between the two countries on the themes of "Real World Data, Risk Management Plan, Expedited Review (Simplified Review) System, and Clinical Trials.
The "3rd Japan-Malaysia Symposium on Pharmaceutical Regulation" was held in Kuala Lumpur, Malaysia on July 31, 2025. The symposium was jointly organized by the National Pharmaceuticals Regulatory Agency (NPRA) of Malaysia, the Pharmaceuticals and Medical Devices Agency (PMDA), and the Malaysian Pharmaceutical Society (MPS) with the aim of deepening cooperation between the two countries.
Two members from the Pharmaceutical Manufacturers Association of Japan (PMAJ), Takayuki Imaeda, Vice Chairman of the Drug Evaluation Committee, and Ayaha Watanabe, Group Leader of the International Committee's Asia Subcommittee for Malaysia, participated as panelists to provide input from the industry.
Update on Pharmaceutical Regulations
First, the latest trends in pharmaceutical regulations in Malaysia and Japan were introduced.
Malaysia introduced its efforts to modernize regulations, while Japan introduced its efforts to strengthen quality and safety, establish a stable supply system, and support the development of innovative drugs through the revision of the Pharmaceuticals and Medical Devices Act.
Use of Real World Data (RWD) and Evidence (RWE)
In the evaluation of pharmaceutical products, there is an accelerating trend to utilize real world data (RWD) and real world evidence (RWE) obtained from actual medical practice. In Malaysia, RWD/RWE is utilized in the evaluation of new drugs and post-marketing surveillance with reference to the guidelines of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and PMDA. In Japan, PMDA has issued several notices on ensuring the reliability of RWD/RWE and supports its utilization in regulatory applications.
Takayuki Imaeda, Vice Chairman of the Pharmaceutical Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PMDA), spoke at this session. In response to a question about the use of RWD/RWE in pharmaceutical companies, he said, "RWD/RWE has a very high potential, but there are still issues such as standardization and structuring. He expressed his view that, although RWD/RWE are generally used in post-marketing surveillance and safety measures, they may be suitable for data conformity and complementary purposes, as well as for hypothesis generation.
Risk Management Plan (RMP)
He then introduced the efforts of both countries in risk management plans (RMPs) to ensure the safety of pharmaceutical products.
While there are some challenges to common RMPs in the Asian region due to language and cultural differences, it was concluded that the establishment of a cooperative framework is the key to the future.
Facilitated Registration Pathway (FRP)
The FRP system in Malaysia was then introduced under the theme of expedited access to medicines. This is a system that speeds up the approval and registration of pharmaceuticals in Malaysia by referring to the approval review results of other countries; from November 2023, PMDA has been added as a reference authority, and Japanese review reports can be utilized in Malaysia. This is expected to accelerate the introduction of innovative drugs into Malaysia and improve patient access.
Ms. Ayaha Watanabe, Malaysia Group Leader of the Pharmaceutical Manufacturers Association of Japan (PMAJ) International Committee Asia Subcommittee, participated in a panel discussion at this session. In response to the question, "What is your view on the use of Japanese review reports in Malaysia's FRP system? In response to the question, "What is your view on the use of the Japanese examination report in Malaysia's FRP system? We expect the process to be faster and more transparent, as inquiries about the contents of Japanese examination reports can be made directly between the authorities. In addition, the PMDA's Asian Training Center for Drugs and Medical Devices (PMDA ATC) has been promoting the use of review reports through training activities to deepen understanding of review reports," he said.
Clinical trials
The final theme was Asian collaboration in clinical trials and future prospects.
In Malaysia, legislation on clinical trials is being developed, aiming for consistency with international standards. Clinical trials in multiple countries present challenges, such as differences in regulations and complex procedures, which are being overcome through cooperation between Japanese and Malaysian clinical trial organizations, regulatory authorities, and industry.
Toward Future Cooperation
The symposium, which covered a wide range of topics, was a valuable opportunity for regulators from both countries to face common challenges and expand possibilities for cooperation. The Pharmaceutical Association of Japan (PAK) will continue to make progress in this area.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) will continue to work to resolve issues in Malaysia and other countries through industry-government collaboration.
Ayaha Watanabe, Malaysia Group Leader of the International Committee's Asia Subcommittee, and Takayuki Imaeda, Vice Chair of the Drug Evaluation Committee
(Ayaha Watanabe, Malaysia Group Leader, International Committee, Asia Subcommittee)