Pharmaceutical News and Updates
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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…
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On Access to Medicines…from WHO
Expenditure on medicines accounts for a major proportion of health costs in developing countries. This means that access to treatment is heavily dependent on the availability of affordable medicines. Although trade in medicines is…
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EMA begins to publish recommendations based on safety signals
The European Medicines Agency has published the first overview listing the recommendations stemming from the assessment of safety signals by the Pharmacovigilance Risk Assessment Committee (PRAC). The document covers all safety signals discussed during the…
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Pay-for-delay settlements under scrutiny
Drug manufacturers urged to reconsider patent dispute strategies in response to ground-breaking EU and US rulings. On 19 June the EC published its first decision on “pay for delay” settlements, levying fines of €93 million on…
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EMA and US FDA outline first assessment of quality-by-design applications
The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements…
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When do you need to update a Risk Management Plan?
There is no longer an automatic requirement to update RMPs on a fixed-time basis. The Agency and the national competent authorities (NCAs) in EU Member States are now adopting a risk-based approach to RMP…