Latest News
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22 March 2013
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The European Medicines Agency (EMA) is once again warning applicants and holders of marketing authorizations to be mindful of the pending addition of Croatia to the EU, which has a number of
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25 February 2013
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The European Medicines Agency (EMA) has announced that application fees will go up approximately 2.6% in the coming fiscal year, roughly on par with the EU rate of inflation for the previous year.The
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Latest News
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25 January 2013
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The European Medicines Agency's (EMA) has released a revised version of its procedural advice for sponsors of medicinal products using the centralised procedure, part of an ongoing series of revisions
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15 January 2013
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The European Medicines Agency (EMA) has launched its eSubmission Gateway and a new eSubmission web client for the submission of applications for human medicines, it announced on 15 January 2013.The
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Regulatory Update
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2 August 2012
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The European Medicines Agency (EMA) is phasing out so-called "follow-up measures" for human drugs requiring post-marketing studies this month, instead replacing them with three categories of
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Regulatory Update
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4 April 2012
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A public consultation on new criteria for prioritizing the review of drug approval applications is planned by Brazil's regulatory agency, ANVISA. The agency intends to propose a point system for
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Latest News
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2 April 2012
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced last week (29 March) it would be making “procedural changes” to the process by which sponsors of marketing authorization
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27 March 2012
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The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced 27 March they have adopted a joint guidance document that will provide a “consistent Europe-wide approach to the
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Latest News
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1 March 2012
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The European Medicines Agency (EMA) released guidance 29 February on how Marketing Authorization Holders (MAH) can submit pharmacovigilance (PhV) systems as part of their Marketing Authorization
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6 January 2012
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European Medicines Agency (EMA) Executive Director Guido Rasi and French Health Minister Xavier Bertrand called on the EU to require medical device makers to go through a more rigorous approvals
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