Pharmaceutical News and Updates
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Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines
From today, the European Medicines Agency requires marketing-authorisation holders to update the information on authorised medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation. This includes completing previously…
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Monitoring of Patent Settlements in Europe
Patent settlement agreements are commercial agreements to settle patent-related disputes, e.g. questions of patent infringement or patent validity. They are concluded in the context of patent disputes, opposition procedures or litigation where no final…
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End of Herbal Sell-through Period
The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding herbal companies and retailers that, as of 1st May 2014, unlicensed manufactured herbal medicines without a traditional herbal registration (THR) or product licence (PL)…
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The 10 leading causes of death in the world (2014 update)
WHO has just published an interesting update to the leading causes of death. We pesent it in this article with some tables for ease of reading. The 10 leading causes of death in the…
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EMA and FDA meet on new initiatives
Senior leadership from DG Health and Consumers (European Commission), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) discussed a number of key initiatives at a bilateral meeting which…
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Orphan Drugs and Ultra-orphan, NICE tries to find a balance.
Earlier this month the UK Bio-Industry Association published a report detailing their recommendations for the new ultra-orphan medicines evaluation framework for ultra-orphan drugs currently being developed by the UK’s Nation Institute for Health and Care…
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Orphan Products Approvals in Europe
A total of 11 out of 81 medicines recommended for marketing authorisation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in 2013 were intended for the treatment of…
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EMA publishes Q&A on Art. 31 Referrals
By Simon Ruini, London 23 Jan 2014 The Q&A guidance document on Article 31 Referrals addresses a number of questions which marketing authorisation holders (MAHs), may have on referral procedures resulting from the evaluation of…
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A reminder on biological applications
Biological similar medicinal products Biological medicinal products have a successful record in treating serious and chronic diseases. The recent expiry of data protection/ patents for the first original biotherapeutics has led to the development and authorisation…
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EMA’s priorities for 2014
The European Medicines Agency’s Management Board, highlighted new priorities for 2014, which include: enhancing cooperation within the European medicines network facilitating early stages of medicines development improving the quality, integration and accessibility of data…