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European budgetary cuts may lead to the reprioritisation and reallocation of resources in response to the challenge of implementing the new Pharmacovigilance legislation, according to the head of Patient Health Protection at the European Medicines Agency (EMA).
Noel Wathion, who was speaking at the annual joint meeting of The Organisation for Professionals in Regulatory Affairs (TOPRA) and the EMA in London, highlighted the challenges for the Agency in 2012- 2013 as it adapts to the changing environment.
The need for more transparency in the wake of the Mediator case has resulted in the EMA releasing more than one million pages of documents in response to requests.
More proactive disclosure is required, said Wathion, and the HMA (Heads of Medicines Agency)/EMA guidance on the identification of commercially confidential information and protection of personal data within the structure of the marketing authorisation dossier should be finalised in the first quarter of 2012.
Wathion noted the need for better drug development information for older people and suggested the impact of globalisation on quality defect issues on drug supply may be a threat to public health.
The EMA is currently working on a reflection paper, which will be finalised at the Management Board this month.