Press Releases

Call for drug and devices approval agency cooperation to meet demand for new category of synergistic drug/ device technologies

Sweden 7-9 October – regulators have called for even greater cooperation between the drug and devices regulatory systems at the first ever joint session between the medicines and devices arms of TOPRA (The Organisation for People in Regulatory Affairs) at its Annual Meeting, Stockholm 6-9 October 2009.

Sweden 7-9 October - Head of the French Agency for the Safety of Health Products (Afssaps) reveals details of a new Head of Medicines Agency (HMA) mandate at the TOPRA annual symposium this week.

Jean Marimbert, Director General of Afssaps, gave delegates a scoop of the HMA's Mandate, still to be formally adopted at the next HMA meeting 28 October in Uppsala, Sweden.

Sweden 7-9 October – Current challenges with the Patient Information proposal were shared by the Commission with delegates at the TOPRA annual symposium this week.

Irene Sacristan Sanchez from the European Commission updated delegates on the “Pharma Package” which includes a legal proposal on Patient Information regarding prescription only medicines – to identify and address the challenges to provide safe, innovative and accessible medicines.

• Personnel news, including the EMEA/ FDA Exchange
• Hot topics – update on biosimilars and how new medicines should be benchmarked
• The US industry perspective

Sweden 7-9 October – The Executive Director of the European Medicines Agency unveiled details of their Road Map to 2015 at the TOPRA Annual Symposium this week.

Thomas Lönngren announced that Road Map 2015 will be a continuation of Road Map 2010, building on current achievements, but also taking due account of the Agency’s business drivers which include public health needs, new and emerging science, increasing globalisation, models for the regulation of medicines, patient safety, transparency and openness.