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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

July 2012

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
20 Jun 2012 Adoption and Publication of Commission Implementing Regulation on pharmacovigilance activities
15 Jun 2012 Finnish Medicines Agency revises regulation on pharmacovigilance of veterinary medicinal products
15 Jun 2012 European Medicines Agency finalises guidance on medicines containing monoclonal antibodies
11 Jun 2012 Dutch Medicines Evaluation Board again ISO certified for one year
08 Jun 2012 European Medicines Agency Management Board completes framework for conflicts of interests
07 Jun 2012 Dutch Medicines Evaluation Board presents annual report with the theme ‘Continuous improvement through scientific underpinning’
07 Jun 2012 Danish Health and Medicines Authority announces new opening hours from 2 July 2012
06 Jun 2012 EMA Annual report 2011 shows continuously high level of activities
04 Jun 2012 U.S. drug recalls common, not well publicized: study


May 2012

31 May 2012 Australian TGA takes a risk-based approach to regulation
10 May 2012 US CDER publishes Strategic Plan for Regulatory Science and Research 2012-2016
09 May 2012 Probe finds collusion between India's drug regulator, pharma firms



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