EMA Reveals Work Program for 2013 - - BioPharm International

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EMA Reveals Work Program for 2013



The management board of the European Medicines Agency (EMA) has endorsed the agency’s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012.

The EMA’s primary goals for the year are to continue to conduct assessment activities to the highest scientific levels, boosting the efficiency of its activities and to develop initiatives for greater transparency and communication with its stakeholders. In addition, the EMA will focus on the continued implementation of Europe’s pharmacovigilance legislation and the new falsified medicines legislation. Revisions are also planned to veterinary medicines legislation.

Several initiatives are taking place at the EMA to increase support to scientific committees, and to assure the quality and consistency of the agency’s outputs. The EMA will be reviewing and optimising scientific processes, such as coordination among committees and continuing to implement policies for conflicts of interest.

New European legislation

The EMA’s management board has endorsed several activities relating to implementing Europe’s new pharmacovigilance legislation. These activities take into account budget constraints because pharmacovigilance fees to aid in implementation are not expected before 2015. Activities to be implemented in 2013 include collecting key information on medicines, such as:

  • guidance preparation for patient reporting
  • better analysis and understanding of data and information
  • regulatory action to safeguard public health, including coordination of pharmacovigilance inspections.

January 2013 will also see the implementation of the falsified medicines legislation. EMA will be working on developing a database that contains certificates of good manufacturing practice and good distribution practice from all member states.

In a statement, the EMA explains that it expects approximately 100 applications for human medicines in 2013, including around 54 applications for new medicinal products, 20 new orphan medicines and 2o generic applications (compared with 52, 13 and 39, respectively, in 2012).

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