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News about GMP/cGMP

EMA: Work Plan 2012

The European Medicines Agency (EMA) released the work programme for 2012.

 

In 2012 the Agency will focus on the following topics:

  • Implementing new pharmacovigilance legislation
  • Implementing revised policies on handling conflicts on interests
  • Ethical and practical GCP (Good Clinical Practice) aspects of clinical trials
  • Progress of Agency interactions with healthcare professionals
  • Supply shortages of medicines caused by insufficient GMP compliance. EMAs Management Board initiated the discussion on a "Reflection paper on medicinal product supply shortages caused by manufacturing/GMP compliance problems".
Outcome:

EMA will publish a detailled work plan in January 2012. The "Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU regulatory authorities" will be presented to the Heads of Medicines Agencies for endorsement in February 2012 as a final step.

Source:

EMA/ Announcement

 

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