Pharmaceutical News and Updates

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,…

Medicines Patent Pool Pediatric ARV Licenses, an interesting way of moving forward on Patents and Access to Medicines

The Medicines Patent Pool (MPP) is an organisation designed to improve the health of people living in low- and middle-income countries. The Pool’s goal is to increase access to quality, safe, effective, more appropriate and affordable medicines, focusing on HIV/AIDS. They do this by negotiating with patent holders to share their HIV medicines…

Towards common EU pricing. European Medicines Agency and EUnetHTA review progress of their cooperation.

The European Medicines Agency (EMA) and EUnetHTA, the European network for Health Technology Assessment (HTA), met to review the progress of their cooperation in London on 14 May 2013. This was the sixth meeting since the start of their collaboration in 2010. The focus of this meeting was on how…

Amendments to the pharmacovigilance legislation

Marketing-authorisation holders of human medicines will now have to declare the reasons that lead them to take any of the actions below to the European Medicines Agency (EMA), in accordance with the amendments to the 2010 pharmacovigilance legislation of the European Union (EU): temporary or permanent marketing cessation or suspension…