8/28付でEC（European Commission）からヒト用医薬品および治験薬のGMPと臨床試験に絡むパブコメ4件が発出されました。
パブコメ締め切りは本年11/24です。
4件のパブコメは以下の通りで、下記URLには4件のパブコメのリンクが張られています。
1. Commission Delegated Act on principles and guidelines on good manufacturing practices for investigational medicinal products for human use and inspection procedures
2. Detailed Commission guidelines on good manufacturing practices for investigational medicinal products
3. Commission Implementing Act on principles and guidelines on good manufacturing practice for medicinal products for human use
4. Detailed arrangement for clinical trials inspection procedures including the qualifications and training requirements for inspectors
http://ec.europa.eu/health/documents/new_en.htm
パブコメ締め切りは本年11/24です。
4件のパブコメは以下の通りで、下記URLには4件のパブコメのリンクが張られています。
1. Commission Delegated Act on principles and guidelines on good manufacturing practices for investigational medicinal products for human use and inspection procedures
2. Detailed Commission guidelines on good manufacturing practices for investigational medicinal products
3. Commission Implementing Act on principles and guidelines on good manufacturing practice for medicinal products for human use
4. Detailed arrangement for clinical trials inspection procedures including the qualifications and training requirements for inspectors
http://ec.europa.eu/health/documents/new_en.htm
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