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What's New at EMA Members only

What’s New at MHLW Members only

September 2012

13 Sep 2012 Japanese PMDA Publishes Presentation: PMDA-Vision: It's Current Situation and Aim for the Future
11 Sep 2012 Health Canada publishes guideline announcing classification of observations noted during establishment inspections according to their risk
10 Sep 2012 European Pharmacovigilance Risk Assessment Committee elects chair and vice-chair
07 Sep 2012 Japanese PMDA Posts Basic Principles on Global Clinical Trials (Reference Cases)"
06 Sep 2012 EU publishes chapter 1, chapter 7 and Annex 2 of the detailed guidelines of the good manufacturing practices


August 2012

30 Aug 2012 European Medicines Agency starts consultation on inventory of needs for children's medicines
23 Aug 2012 India Issues Guidelines for Similar Biologics
17 Aug 2012 Chinese SFDA Commissioner Yin Li meets the delegation of Ireland Department of Health and Children
16 Aug 2012 New EU publication: New rules on importing active pharmaceutical ingredients into the European Union
14 Aug 2012 British siimplified medicines regulations come into force
09 Aug 2012 US FDA Publishes "Guidance Agenda - New & Revised Draft - Guidances CDER is Planning to Publish During Calendar Year 2012"
09 Aug 2012 EU proactively publishes clinical trial data – discussing the way forward
03 Aug 2012 Chinese Requirements on Strengthening Supervision and Management of Pharmaceutical Excipients released
01 Aug 2012 European Commission proposes new clinical trials regulation


July 2012

31 Jul 2012 US FDA Releases Video Explaning Accelerated Approval Program
30 Jul 2012 European Medicines Agency sees benefits of interaction with Japanese regulators
30 Jul 2012 US FDA Publishes Foods and Veterinary Medicine Strategic Plan 2012 - 2016
26 Jul 2012 European Medicines Agency releases two further modules on good pharmacovigilance practices for public consultation
25 Jul 2012 New rules on importing active pharmaceutical ingredients into the EU – information leaflet
23 Jul 2012 European regulators back first gene therapy drug



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