The GMP Regulations Report 2018

2/19付のGMP Publishingが「The GMP Regulations Report 2018」と題して、2018年度の17点の重要な規制動向の概要を述べています。
 
 1.FDA: Guidance on Data Integrity and Compliance with Drug CGMP, December 2018
 2.EU/US: Q&A to MRA on Inspections, December 2018
 3.EMA: Q&A to Safety Features for Medicinal Products, November 2018
 4.EMA: Draft Guideline on the Quality of Water for Pharmaceutical Use, November 2018
 5.ICH: Revised Q3C(R7) on Impurities: Guideline for Residual Solvents, October 2018
 6.CDSCO India: Draft Guideline on GDP for Pharmaceuticals, October 2018
 7.EC: New Annex 2 for Manufacturing Biological Products, June 2018
 8.EC: New Annex 17 on Real Time Release Testing and Parametric Release, June 2018
 9.EMA: Update of Two Brexit Guidance Documents, June 2018
10.PIC/S: New Guidance Documents, June 2018
11.WHO: 52nd Technical Report Series No.1010, June 2018
12.EMA: Q&A on Health-Based Exposure Limits, April 2018
13.WHO: Three Draft Documents for Commentation, March 2018
14.MHRA: „GxP Data Integrity Guidance and Definitions“, March, 2018
15.MHRA: Out of Specification Guidance
16.EC/EMA: New Guidelines on ATMPs, February 2018
17.Swissmedic: Authorisation of Biosimilars and Q&A Document, January 2018
 
興味のある方は、下記URLの抄録をご参照ください。
上記の各ガイドライン等は抄録内にリンクされています。
https://www.gmp-publishing.com/content/en/gmp-news/gmp-newsletter/gmp-logfile-lead-article/d/1405/gmp-logfile-06-2019-regulations-report-2018
 
ちなみに、筆者の記憶としては、全てのものに対しGMP Platformトピックスとしてお伝えしております。
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