Pharmaceutical News and Updates
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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…
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Changing the rules of the game. EMA and EUnetHTA’s new 3 year plan.
The collaboration between regulatory and technology assessment bodies has the potential to change the approach to product development and approval in Europe. This collaboration, that was started in 2008, is likely to have an impact on stakeholders in…
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WHO guideline on recombinant DNA products
Simon Ruini, London After having completed the last round of consultation with the public, WHO expert group is about to publish the approved and final version of the Guidelines on the Quality, Safety, and Efficacy…