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 centrally and nationally authorised medicines. A [read more…]
Archive for the ‘Pharmaceutical News’ Category
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 introduced a few years ago [read more…]
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 an NCA Whenever the risk-management [read more…]
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 pharmaceutical researchers to adjust their [read more…]
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, paediatric plans and drug safety [read more…]
Avandia new evidence to be evaluated next week in the U.S.
In 2010 the drug Avandia (rosiglitazone) was restricted in the US and banned in EU, after researchers found that patients were possibly subject to increased risk of heart problems after taking it. Today, Avandia is a drug of last resort in many parts of the World for people with diabetes who are so sick [read more…]