Pharmaceutical News and Updates

The EU executive is planning a major overhaul of the rules governing medical research amid a growing acceptance that a directive in place since 2004 has hampered clinical trials

The European Commission says it accepts that the implementation of the directive has been deeply flawed and will legislate to fix the problems by October 2011. The Commission’s health directorate – which was handed control of EU pharmaceutical policy earlier this year describes the Clinical Trials Directive as “arguably the most criticised…

Innovation is in for EU’s Healthcare SystemEurope aim to increase jobs and growth through its “Europe 2020” strategy

By Peter O’Donnell It will come as little consolation to those already struggling to keep up with change to learn that more change is already on the way. Innovation is in, in Europe—again. And not just in the recast of the EU’s clinical trials rules currently brewing within the bureaucrats’…

European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation

European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation On 15 April 2011, the European Medicines Agency held a stakeholder forum on the implementation of the new pharmacovigilance legislation with a broad cross-section of participants including industry, patient and healthcare professional representatives and national…

Should Doctors Shoulder Healthcare Costs?

By Jennifer Ringler As the debate over the rising costs of new drug R&D and brand name medications rages on, physicians are increasingly doing their part to minimize collateral damage inflicted upon the patient. A new report from Bain & Company — The new cost-conscious doctor: changing America’s healthcare landscape…

Justices debate lawsuits over generic drug safety

By Bill Mears, CNN Supreme Court Producer Two women developed tardive dyskinesia after taking generic drugs The justices are considering cases against pharmaceutical manufacturers Generic drugs account for 70% of all prescriptions filled in the U.S. Washington (CNN) — Two women who say they suffered severe medical complications from a…

Can you apply for a Centralised Marketing Authorisation in Europe ?

Medicinal products falling within the mandatory scope of the Annex of Regulation (EC) are obliged to apply for a Centralised Procedure: Recombinant DNA technology-Controlled expression of genes Hybridoma and monoclonal antibody methods Biosimilar biological medicinal products which are developed by one of the above Biotechnological processes also fall under the…