5/16付のGMP Publishingが「2017 – The GMP Regulations Report」と題する抄録を掲載しています。
そのタイトル通り、2017年度のGMP関連規制のサマリー報告です。
取り上げているものとしては、以下のような24点があります。
筆者の感覚としては、結構要所を押さえているように思います。
・EMA: Draft Q&A on Health Based Exposure Limits, January 2017
・PIC/S: GMP Guide PE 009-13, January 2017
・FDA: Final Guidance on cGMP for Combination Products, January 2017
・EMA: Concept Paper for Drug-device Combination Products, February 2017
・EMA: Implementation strategy of ICH Q3D guideline, March 2017
・EMA: Concept Paper on the Revision of Note on Quality of Water for Pharmaceutical Use, March 2017
・EC: New Regulation on Medical Devices, April 2017
・EC: Commission Delegated Regulation (EU) 2017/1569, May 2017
・EMA: Regulatory Guidance on Brexit for the Pharmaceutical Industry Q&A, June 2017-January 2018
・FDA: Draft Q&A to Electronic Records and Signatures in Clinical Investigations – 21 CFR 11, June 2017
・FDA: Draft on cGMP for Medical Gases, June 2017
・European Pharmacopoeia: Draft of the Monography to Purified Water, June 2017
・EC: Safety Features for Medicinal Products for Human Use, Q&A Version 7, July 2017
・WHO: Technical Report Series 1003, 51st report, July 2017
・EMA: Q&As on Production of Water for Injections by Non-distillation Methods – Reverse Osmosis and Biofilms and Control Strategy, August 2017
・EMA: Final Guideline on the Manufacture of the Finished Dosage Form, August 2017
・EC: Commission Directive (EU) 2017/1572, September 2017
・ICH: Q11 Q&A in Step 4, September 2017
・Switzerland: Revision of Medical Devices Legislation, November 2017-ongoing
・EC/EMA: Guidelines on GMP specific to ATMPs, November 2017
・EMA: Practical Guidance for Procedures related to Brexit for Medicinal Products for Human and Veterinary Use, November 2017 – January 2018
・ICH: Draft of ICH Q12 to Pharmaceutical Product Lifecycle, November 2017
・EC: Detailed Guidelines on GMP for Investigational Medicinal Products for Human Use, November 2017
・EC: Draft to Annex 1 on Sterile Manufacturing, December 2017
夫々について、元ネタのニュース記事やガイドライン等がリンクされているという優れものです。
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.gmp-publishing.com/en/lead-article/gmp-aktuell/gmp-logfile-189018-gmp-regulations-report.html
そのタイトル通り、2017年度のGMP関連規制のサマリー報告
取り上げているものとしては、以下のような24点があります。
筆者の感覚としては、結構要所を押さえているように思います。
・EMA: Draft Q&A on Health Based Exposure Limits, January 2017
・PIC/S: GMP Guide PE 009-13, January 2017
・FDA: Final Guidance on cGMP for Combination Products, January 2017
・EMA: Concept Paper for Drug-device Combination Products, February 2017
・EMA: Implementation strategy of ICH Q3D guideline, March 2017
・EMA: Concept Paper on the Revision of Note on Quality of Water for Pharmaceutical Use, March 2017
・EC: New Regulation on Medical Devices, April 2017
・EC: Commission Delegated Regulation (EU) 2017/1569, May 2017
・EMA: Regulatory Guidance on Brexit for the Pharmaceutical Industry Q&A, June 2017-January 2018
・FDA: Draft Q&A to Electronic Records and Signatures in Clinical Investigations – 21 CFR 11, June 2017
・FDA: Draft on cGMP for Medical Gases, June 2017
・European Pharmacopoeia: Draft of the Monography to Purified Water, June 2017
・EC: Safety Features for Medicinal Products for Human Use, Q&A Version 7, July 2017
・WHO: Technical Report Series 1003, 51st report, July 2017
・EMA: Q&As on Production of Water for Injections by Non-distillation Methods – Reverse Osmosis and Biofilms and Control Strategy, August 2017
・EMA: Final Guideline on the Manufacture of the Finished Dosage Form, August 2017
・EC: Commission Directive (EU) 2017/1572, September 2017
・ICH: Q11 Q&A in Step 4, September 2017
・Switzerland: Revision of Medical Devices Legislation, November 2017-ongoing
・EC/EMA: Guidelines on GMP specific to ATMPs, November 2017
・EMA: Practical Guidance for Procedures related to Brexit for Medicinal Products for Human and Veterinary Use, November 2017 – January 2018
・ICH: Draft of ICH Q12 to Pharmaceutical Product Lifecycle, November 2017
・EC: Detailed Guidelines on GMP for Investigational Medicinal Products for Human Use, November 2017
・EC: Draft to Annex 1 on Sterile Manufacturing, December 2017
夫々について、
興味のある方は、下記URLのニュース記事をご参照ください。
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
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