Medical device regulation in India & Japan

Medical device regulation in India & Japan discussed at 4th India-Japan Medical Products Regulatory Symposium

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Bp Apparatus, Medical Devices
Picture: Pixabay

Clinical trials and regulatory supports for innovative drug development in Japan, latest trend of clinical trial requirements in pre and post marketing phase in India, and medical device and IVD regulation in both the countries were discussed at the 4th India -Japan Medical Products Regulatory Symposium held recently in Tokyo, Japan.

The Indian delegation which was led by Mona Khandhar, Minister (Economic and Commerce), Embassy of India, Tokyo, Japan had participation of representatives from Ministry of Health, Labour and Welfare (MHLW), Japan, Pharmaceutical and Medical Device Agency (PMDA), Japan, Ministry of health and family welfare (MOHFW), Central Drugs Standard Control Organization (CDSCO), India.

The symposium was supported by Japan Pharmaceutical Manufacturers Association (JPMA), Japan, Federation of Pharmaceutical Manufacturers’ Associations of Japan, (FPMAJ), Japan, Japan Federation of Medical Devices Association (JFMDA), Forum for Innovative Regenerative Medicine (FIRM), India, Pharmaceuticals Export Promotion Council of India (Pharmexcil), India and Federation of Indian Chambers of Commerce and Industry (FICCI), India.

During the symposium, Dr. Kunitada Satoshi, chairperson, JPMA talked about the strategies and challenges for innovative drug development and Dr V G Somani, Drugs Controller General of India (DCGI), CDSCO, India gave an update on medical device and IVD Regulation in India.

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Following which, Takanashi Fumihito, deputy director, MHLW gave an update on Medical Device and IVD Regulation in Japan.

A talk on Regulatory system on Generic Drugs in Japan was given by Tanaka Katsuya, section chief, MHLW. Following which Dr Hemant G Koshia, commissioner, Food and Drug Control Administration (FDCA), Gujarat gave a low down on the generic drugs assessment and approval process in India.

During the deliberations, Hayakawa Masakane from FPMAJ shared his perspective on the challenges in development and stable supply of generic medicines to Japan.

Udaya Bhaskar, director general, Pharmexcil and KV Nagi Reddy, director, Department of Commerce, India gave their perspective on the regulatory system on generic drugs in India.

Dr. Maruyama Yoshiaki, review director, PMDA talked about updates on regulatory landscape of regenerative medicine in Japan and Dr V G Somani, DCGI, CDSCO gave insights on the real world of regenerative medicine products review in India.

Talks primarily focused on medical device regulation and international cooperation of India, latest trend of pharmaceutical, medical device regulation and international co-operation of Japan and strategies and challenges for innovative drug development in India and Japan. Deliberations also focused upon GMP and drug approval review process in both the countries.

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