PMDA to Promote New Drug Developments in Japan by Raising Awareness among U.S. based Biotech Companies about Regulations in Japan

According to the news article “PMDA米国拠点、ラグ/ロス解消が使命  藤原理事長、日本の薬事制度を周知・浸透へ | 日刊薬業 – 医薬品産業の総合情報サイト (” released by THE NIKKAN YAKUGYO on July 07, 2023, Yasuhiro Fujiwara, the President of the Pharmaceuticals and Medical Devices Agency (PMDA), has announced plans to establish their overseas operation bases in the United States and Asia to disseminate information about Japan’s pharmaceutical regulations. The US base aims to enhance collaboration between regulatory authorities in Japan and the United States, raise awareness of Japan’s pharmaceutical regulations among local companies and stimulate new drug development. This movement is also intended to diminish the “drug lag and loss” issue that is currently becoming a problem in Japan’s healthcare industry. These new overseas bases, planned for Washington, the US and Bangkok, Thailand, are set to start operations in the fiscal year 2024. While PMDA does not have a European base, they dispatch personnel to the European Medicines Agency (EMA) for information exchange. President Fujiwara expressed his intention to strengthen relationships through face-to-face meetings, acknowledging the time differences as a challenge. Furthermore, he emphasized the need for seamless transmission of vital information on Japanese pharmaceutical policies and guidelines to global stakeholders. This ensures more timely and effective communication for those involved in pharmaceutical development. The US base aims to showcase the appeal of Japan’s pharmaceutical regulations, attract the interest of US companies, and redirect their focus towards the Japanese market, thereby contributing to the resolution of “drug lag and loss in Japan.”