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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 2013

03 Jul 2013 U.S. FDA to propose allowing generic drugmakers to update drug labels
02 Jul 2013 US FDA: Fostering innovation to protect national health and security
02 Jul 2013 US FDA Issues Guidance on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection


June 2013

24 Jun 2013 ICH Pursues its Reform and Takes Steps Towards Increased Transparency
24 Jun 2013 US Justices block generic drug liability lawsuits
24 Jun 2013 Information for Industry on the proposed regulatory amendments to submit mock-ups of labels
21 Jun 2013 FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers
19 Jun 2013 Call for overhaul of drug industry business model
14 Jun 2013 U.S. top court bars patents on human genes unless synthetic
06 Jun 2013 Exemption of the EU’s regulatory control applicable to APIs exported from Japan to the European Union


May 2013

27 May 2013 EU issues Questions and Answers on agreement between Israel and the EU on conformity assessment and acceptance of industrial products
27 May 2013 Road map for the Japanese PMDA International Vision
24 May 2013 US FDA releases guidance: Contract Manufacturing Arrangements for Drugs: Quality Agreements
23 May 2013 European Medicines Agency issues six key recommendations to tackle the issue of medication errors
23 May 2013 US Official testifies on drug compounding
17 May 2013 Summary of the Canadian Quality System Framework
14 May 2013 Turkey applies for PIC/S membership
14 May 2013 Mexico applies for PIC/S pre-accession membership
07 May 2013 Overview of Changes to the Estonian Medicinal Products Act
03 May 2013 US FDA’s Collaboration with Chinese Partners Gets Stronger Each Year



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