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 medicines for rare diseases observed [read more…]
Archive for the ‘Pharmaceutical News’ Category
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 with regards to the handling [read more…]
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 the European Union (EU). The principles [read more…]
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 European Union (EU) are of [read more…]
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 the future. In particular, some aspects of development and early post-marketing could be affected by the potential influence of Real World Data and cost-effectiveness in the [read more…]
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 of Biotherapeutic Products Prepared by Recombinant DNA Technology. These guidelines apply, in principle, to all biologically active protein products used [read more…]