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What's New at EMA Members only

What’s New at MHLW Members only

September 2009

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17 Sep 2009 Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines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
15 Sep 2009 Consultation on Good Manufacturing Practices- Program Review
15 Sep 2009 The Better Regulation of Medicines Initiative (BROMI) publishes its fourth progress report
15 Sep 2009 China's SFDA Deputy Commissioner Wu Zhen meets CEO of the Danish Medicines Agency
14 Sep 2009 Draft Guidance for Industry and FDA Staff - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation
11 Sep 2009 MHLW Pharmaceuticals and Medical Devices Safety Information
09 Sep 2009 The Proceedings of the "ICH Japan Symposium 2009", Tokyo, Japan, 12 June, 2009
08 Sep 2009 Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection ...
07 Sep 2009 Corrected Questions and Answers - Common Technical Documents for the Registration of Pharmaceuticals for Human Use
03 Sep 2009 FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines
01 Sep 2009 Revision of PIC/S GMP Guide
01 Sep 2009 Australia's TGA Updates Increased Transparency of the Prescription Medicine Regulatory Process
01 Sep 2009 FDA Issues Draft Guidance on Risk Evaluation & Mitigation Strategies
01 Sep 2009 news link
01 Sep 2009 Australia's TGA News - New TGA Structure, New Code of Good Manufacturing Practice, and More



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