At the recent TOPRA joint meeting with EMA, Noel Wathion (EMA) highlighted the challenges for EMA in 2012- 2013 as it adapts to the changing environment. Budgetary cuts may lead to reprioritization and reallocation of resources in order to meet the challenge of implementation of the new Pharmacovigilance legislation. The need for more transparency in the wake of the Mediator case has resulted in EMA releasing more than 1 million pages of documents in response to requests. They need to move to more proactive disclosure and the HMA/EMA guidance on the identification of commercially confidential information and protection of personal data within the structure of the marketing authorisation dossier is planned to be finalized in 1Q2012. He also noted the need for better drug development information for older people. The impact of globalization on issues such as quality defect issues on drug supply may be a threat to public health. EMA is working on a reflection paper which has been agreed at HMA meeting in Nov and due for agreement at the Management Board in December.

Nuno Simoes (Infarmed) covered the perspective of the National Competent Authorities firstly covering the HMA strategy priority areas and implementation plans, and then the Infarmed (Portugal) strategic road map. He stressed that the HMA plans are complementary to the EMA Roadmap and also highlighted the increased level of worksharing amongst the Agencies. At the Infarmed level he mentioned their increasing contributions to DCP and MRP assessments, and outlined the challenges faced due to health resource constraints resulting in reductions in budgets.

Jean Claude Brival (EMA) briefly described the Agency’s operational excellence initiative which is designed to increase efficiency in the Agency without compromising quality. In response to a question from the audience he mentioned that it is planned to seek some stakeholder input into this.
London 24 – 25 November 2011 – this meeting is an annual event organised by TOPRA with EMA and was held this year in the EMA building in Canary Wharf.

Notes to Editors

Media and interview enquiries:

Jenine Willis, TOPRA Publishiing
Telephone: +44 (0)20 7510 2560

The Organisation for Professionals in Regulatory Affairs (TOPRA)

TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Current membership is drawn from over 40 countries and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, the regulatory agencies and the consultancy community and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals.

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