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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

December 2009

09 Dec 2009 European Medicines Agency launches new organisational structure and new visual identity
09 Dec 2009 Australia Introduces Fourth Bill to enhance the Therapeutic Goods Act 1989
07 Dec 2009 Malta's Medicines Authority Awarded The Foundation For Human Resources Development - HR Award
04 Dec 2009 TGA Issues New Biologicals Framework Newsletter
04 Dec 2009 PIC/S Issues Technical Interpretation of Revised Annex 1 TO PIC/S GMP Guide
02 Dec 2009 ICH Quality Implementation Group on Q8-Q9-Q10 Has Released a New Set of Q&As
01 Dec 2009 EMEA Announces Several Important Upcoming Changes


November 2009

01 Nov 2009 International operation combats the online supply of counterfeit and unlicensed medicines
01 Nov 2009 SFDA intensifies supervision on production and quality of essential drugs


October 2009

12 Oct 2009 Britain's MHRA Announces New Risk-Based Inspection Programme for good practice inspections
09 Oct 2009 General Principles: EMEA- FDA Parallel Scientific Advice


September 2009

23 Sep 2009 FDA Proposes New GMP Regulation for Combination Products   79 KB
21 Sep 2009 FDA Announces Public Hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools
21 Sep 2009 European Medicines Agency's position on participation in the Innovative Medicines Initiative (IMI)
18 Sep 2009 Notice to Applicants, Volume 2B - Electronic Common Technical Document (eCTD)
18 Sep 2009 Notice to Applicants_Veterinary Medicinal Products_Volume 6B
18 Sep 2009 Notice to Applicants_Veterinary Medicinal Products_Volume 6C
18 Sep 2009 Revised Qualification of novel methodologies for drug development: Guidance to applicants
18 Sep 2009 End-of-Phase 2A Meetings
18 Sep 2009 Appointments to the British Pharmacopoeia Commission



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