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Regulatory Update | 14 January 2013

China Sets Deadlines for Drug GMP Implementation

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China’s State Food and Drug Administration (SFDA), the National Development and Reform Commission, the Ministry of Industry and Information Technology, and the Ministry of Health issued on 21 December Read More...


Latest News | 27 June 2012

Additional Pharmacovigilance Guidelines Released by EMA

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The European Medicines Agency (EMA) has released its final two guidelines on good pharmacovigilance practices (GVPs) after releasing seven similar GVP guidelines on 22 June.The final two guidelines Read More...


Latest News | 23 May 2012

EMA Releases 'Practical Guidance' for Implementation of Pharmacovigilance Legislation

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The European Medicines Agency (EMA) announced it has released what it is calling “practical guidance” in the form of a question and answer document seeking to answer some of the more common questions Read More...


Latest News | 10 May 2012

FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

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The US Food and Drug Administration (FDA) announced 10 May it will delay implementation of a final rule intended to establish labeling and effectiveness testing for over-the-counter (OTC) sunscreen Read More...


Latest News | 27 April 2012

European Commission Demands Bulgaria 'Correctly Implement' Regulatory Legislation

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What happens when an EU country fails to “correctly implement” a legislative directive? A harsh scolding from the European Commission (EC) and threats to haul the country before a the European Court Read More...


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