Pharmaceutical News and Updates

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…

WHO highlights pharmaceutical issues for ageing conditions

For the first time, EU countries have more people over 65 years of age than under 15 years of age. Echoing the trend seen in Europe, much of the rest of the world, including low-and middle-income countries, is moving in a similar direction. A new WHO report calls for…

Marketing in more complex healthcare systems

By Simon Ruini, London Marketing strategies have evolved as a result of more complex healthcare systems. Payer’s restrictions, value based pricing, increased safety surveillance and ongoing regulatory support mandates a bird’s eye view strategy as well as sound contingency plans. Furthermore, the changes introduced by recent legislation on clinical trials,…