寶田哲仁 – GMP Meister®

寶田哲仁

2025-01-17 ｜記事

Current Regulatory Status of Regenerative Medicine and GMP/GCTP in Japan

For regenerative medicine, the applicable legal regulations differ based on whether the products are distribut […]

2025-01-14 ｜記事

Regulations related to GMP in Japan – Tets Takarada

Pharmaceutical products intended for the Japanese market shall comply with the Pharmaceuticals and Medical Dev […]

2025-01-14 ｜記事

Release of the revised version of the Q&A for ICH Q8/Q9/Q10 – Tets Takarada

The Q&A for Q8/Q9/Q10 was created by the ICH Q-IWG and was issued in 2009. It was revised as R5 on October […]

2024-12-20 ｜記事

ICH Q8/Q9/Q10に関する質疑応答集の改訂版のリリースについて – 寳田哲仁

Q8/Q9/Q10に関する質疑応答集は、ICHのQuality Implementation Working Groupで作成され、国内では、2010年9月に事務連絡として出されたところですが、今回、ICHで改訂版がリリ […]