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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

August 2012

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
19 Jul 2012 Chinese SFDA Commissioner Yin Li meets WHO Director-General Dr Margaret Chan
17 Jul 2012 Britain's MHRA asks for views about giving patients earlier access to medicines
13 Jul 2012 Japan publishes "Answers to the Questions on Generic Drugs" in Japanese
13 Jul 2012 Korea Food and Drug Administration signed a memorandum of understanding with Indonesian National Agency of Drug and Food Control
13 Jul 2012 US FDA Publishes "Small Business Chronicles" on topic of Orpahn Drugs
09 Jul 2012 US Food and Drug Administration Safety and Innovation Act (FDASIA) signed into law


June 2012

26 Jun 2012 EU Commissioner Dalli visits the US
21 Jun 2012 E3 Q&As on Structure and Content of Clinical Study Reports available on the ICH website



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