On January 16, 2023, GRP Japan executives meet with a team of PMDA regulatory to introduce their MAH Capabilities in Japan. GRP-Japan has been an MAH in Japan since 2016. Its main clientele mainly being Europeans and American sponsors and manufacturers who want to enter Japan’s Market. GRP Japan Briefly explained some the clients’ general products and some of the difficulties in bridging regulations between PMDA with other regulators like the FDA and EMA.
Japan's Drug Lag
The difference in regulations opened up the conversation to talking about Japan’s Drug Lag. The PMDA communicated to GRP that Japan is currently experiencing a drug lag and asked GRP-Japan on why we think that might be happening as we are in the “front line” on bridging Business in Japan.
GRP assured the PMDA this was not due to a lack of interest in foreign companies to enter Japan but rather a lack of information in English. However, GRP-Japan is doing everything it can to support these companies in entering Japan. From educating the clients on Japan Regulations, Translating the PMDA regulations in-house and having a full bilingual team.
The Future: PMDA's 5-year Plan
PMDA communicated with GRP its 5-year plan in where they hope to make their regulations more accessible to foreign sponsors. The PMDA has been making a great effort in releasing more information to the public from their monthly English newsletters and their online training videos. The meeting ending on a positive note, as both sides, the regulator’s sector and business sector are doing all they can to improve the current situation in Japan.
About Global Regulatory Partners Group
Global Regulatory Partners, Inc (GRP) is a global provider of tailored clinical development, regulatory affairs, quality and pharmacovigilance services for pharma, biotech, medical devices and cosmetic industries worldwide. Global Regulatory Partners. Inc, has now over 500 employees, 6 affiliates in 6 countries (USA, Brazil, Mexico, Japan, China and South Korea) and more than 500 satisfied clients worldwide.