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Regulatory Update
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12 March 2013
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The European Commission issued final revised Good Distribution Practices (GDP) guidelines on 8 March 2013 that are designed to incorporate the requirements of a 2011 Directive that targets so-called
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Regulatory Update
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6 February 2013
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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has submitted recommendations to the European Commission to amend the recently implemented EU pharmacovigilance legislation. In a
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17 January 2013
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The European Commission (EC) has launched a public consultation on four revised chapters of its good manufacturing practice guidelines, saying a number of changes were necessary to reflect best
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Regulatory Update
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26 November 2012
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The European Commission has opened a consultation on the time needed by companies to implement product packaging changes under the new EU pharmacovigilance law.Under that legislation, companies are
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5 October 2012
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The European Commission has released new amendments to the EU's recent pharmacovigilance legislation after it said it was made aware of several potential loopholes through which dangerous products
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Regulatory Update
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4 October 2012
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The European Commission yesterday released a Communication opening a second regulatory review to ensure the safe use of nanomaterials. The regulatory review is a systematic analysis of all current
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Regulatory Update
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9 August 2012
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The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published seven announcements calling for information and experts on a host of emerging and
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20 July 2012
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use the first gene therpy product in the European Union, regulators said Friday, 20
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18 July 2012
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The European Commission (EC) has released a new proposal aimed at reforming Europe’s pharmaceutical clinical trials regulations, dismantling an earlier attempt to modernize the rules and instead
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19 June 2012
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The European Commission has released a concept paper laying out the case for the collection of user fees under pharmacovigilance legislation set to go into effect in July 2012.The concept paper
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