2017年度に入ってからの改訂ガイドライン等をリストアップしました。
必ずしもGM Platform読者に関係するものとは限りませんが、ご参考まで。
ちなみに、現在改訂中のものは挙げておりませんので、悪しからずご了承ください。
●「WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (revision)」
Annex 6, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/areas/quality_safety/quality_assurance/trs1003_annex6.pdf
●「General background notes and list of international comparator pharmaceutical products」
Annex 5, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex5.pdf
●「WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices」
Annex 4, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/areas/quality_safety/quality_assurance/trs1003_annex4.pdf
●「The International Pharmacopoeia: revised concepts and future perspectives」
Annex 2, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/areas/quality_safety/quality_assurance/trs1003_annex2.pdf
●「Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies (revised)」
Annex 3, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/areas/quality_safety/quality_assurance/trs1003_annex3.pdf
必ずしもGM Platform読者に関係するものとは限りませんが、
ちなみに、現在改訂中のものは挙げておりませんので、
●「WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (revision)」
Annex 6, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/
●「General background notes and list of international comparator pharmaceutical products」
Annex 5, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/
●「WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices」
Annex 4, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/
●「The International Pharmacopoeia: revised concepts and future perspectives」
Annex 2, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/
●「Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies (revised)」
Annex 3, WHO Technical Report Series 1003, 2017
http://www.who.int/medicines/
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
コメント
/
/
/
コメント