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What's New at FDA  Members only

What's New at EMA Members only

What’s New at MHLW Members only

November 2010

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
15 Oct 2010 European Medicines Agency mid-year report 2010 from the Executive Director (January - June 2010)
14 Oct 2010 European Medicines Agency strengthens rules on conflicts of interests of its scientific experts
14 Oct 2010 International operation combats the illegal online supply of counterfeit medicines
12 Oct 2010 US General Accounting Office Publishes: Biological Laboratories: Design and Implementation Considerations for Safety Reporting Systems
12 Oct 2010 European Medicines Agency Management Board adopt new policies on handling of conflicts of interests and on access to documents
06 Oct 2010 US FDA awards $904,000 to Pan American Health Organization for information ‘hub’
06 Oct 2010 US FDA Issues Regulatory Science Report
06 Oct 2010 Danish Medicines Agency Publishes Implementation of new validation rules for electronic exchange of adverse reaction data
04 Oct 2010 Summary of the annual report of the European Medicines Agency 2009
04 Oct 2010 Swedish Medical Products Agency Evaluates Pilot Project of Joint Scientific Advice Meetings
04 Oct 2010 PIC/S Conducts Follow-up visit to US FDA
04 Oct 2010 The FDA Interview: Is pharma getting worse at manufacturing? by Phil Taylor, Courtesy of, Publisher, John Wiley & Sons Ltd.



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