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December 2009

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 European Medicines Agency's position on participation in the Innovative Medicines Initiative (IMI)
21 Sep 2009 FDA Announces Public Hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools
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
17 Sep 2009 Consultation on the Creation of a regulatory framework for the implementation of Good Manufacturing Practices for active pharmaceutical ingredients
17 Sep 2009 Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
17 Sep 2009 Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
17 Sep 2009 Joint ECDC-EMEA report highlights urgent need for development of new antibiotics
16 Sep 2009 Guidance for Industry: Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation
15 Sep 2009 Guideline on non-clicical and clinical development of Similar medicinal products containing recombinant Erythropoietins



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