Pharmaceutical News and Updates

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 took place in London from 31 March to 1 April 2014. These meetings take place…

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 Excellence (NICE). The report recognises that national regulators within the EU have failed to strike…

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 rare diseases. This continues the year-on-year increase in the number of marketing authorisation recommendations for…

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 data from pharmacovigilance activities. It provides an overview of the Agency’s practical and operational aspects…

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 of copy versions, termed ‘similar biological medicinal products’ (biosimilars) by the European Medicines Agency in…

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 held by the Agency reinforcing international cooperation to ensure that clinical trials conducted outside the…