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What's New at EMA Members only

What’s New at MHLW Members only

November 2010

18 Nov 2010 European Medicine Agency's Committee for Advanced Therapies adopts five-year work programme to foster development of advanced therapies
16 Nov 2010 Revisions to Chapter 7: Outsourced Activites of EU GMP Guide
11 Nov 2010 European Medicines Agency and Massachusetts Institute of Technology launch joint project on regulatory science
10 Nov 2010 MHRA Communication Strategy 2010 - 2015 published
09 Nov 2010 US FDA: Majority of drug and biological product makers meeting postmarketing requirements and commitments
08 Nov 2010 Global Regulatory News   183 KB  Members only
05 Nov 2010 US FDA and Health Canada - Completion of the pilot Multipurpose Audit Program
05 Nov 2010 Selection of new members for the Tenth Chinese Pharmacopoeia Commission started
05 Nov 2010 Appointment of an Acting Executive Director at the European Medicines Agency
03 Nov 2010 Recruitment procedure for new Executive Director of the European Medicines Agency started
03 Nov 2010 Audit of the Estonian State Agency of Medicines by Health Canada completed with positive conclusion
03 Nov 2010 TGA looks to improve regulatory framework for medical devices
01 Nov 2010 The Therapeutic Goods Administration has commenced a streamlined submission process for selected prescription medicines applications in Australia.
01 Nov 2010 US GAO Publishes "DRUG SAFETY: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments ...

 

October 2010

29 Oct 2010 Memorandum on Information Exchange between the Medicines and Healthcare products Regulatory Agency and the Ministry of Health, Labour and ...
28 Oct 2010 "Estonian Statistics on medicines 2006-2009“ has been published
22 Oct 2010 Finnish Medicines Agency Publishes New Regulation and Guideline for Labelling and Packaging Leaflets for Medicinal Products
22 Oct 2010 Australia and Canada - Reciprocal Recognition of Manufacturers' Quality Systems
19 Oct 2010 Japan's PMDA Publishes Annual Report 2009
18 Oct 2010 Philippines Food and Drug Administsration Publishes: Draft Administrative Order on Guidelines for GMP Clearance and Audit of Foreign Manufacturer

 

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