Pharmaceutical News and Updates

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…

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 increasing rapidly, most of it takes place between wealthy countries, with developing countries accounting for…

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 September 2013 PRAC meeting and the recommendations given for each of them. It includes PRAC recommendations for…

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 Lundbeck, a Danish pharmaceuticals developer. The decision was followed, just two days later, by a…

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 of marketing-authorisation applications. Quality-by-design is a science- and risk-based approach to pharmaceutical development and manufacturing that was…

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 updates. An updated RMP should now be submitted: At the request of the Agency or…