EMA released pharmacovigilance guidelines for public consultation

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EMA has released its first batch of guidelines on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012.


Each of the seven pharmacovigilance modules released by EMA covers a major process in the safety monitoring of medicines, these modules are:

  • Module I: Pharmacovigilance systems and their quality systems
  • Module II: Pharmacovigilance systems master files
  • Module V: Risk management systems
  • Module VI: Management and reporting of adverse reactions to medicinal products
  • Module VII: Periodic safety update reports
  • Module VIII: Post-authorisation safety studies
  • Module IX: Signal management.

GVP is a set of measures drawn up to facilitate the performance of pharmacovigilance in the EU. They apply to marketing-authorisation holders, the Agency and medicines regulatory authorities in EU Member States and aim to improve safety for patients.

Pharmacovigilance is the monitoring of the safety of medicines during their use in the general public and these guidelines will have to be followed in the same way by manufacturers of originator, generic and biosimilar drugs.

Pharmacovigilance is of high relevance to originator biologicals and biosimilars, since slight changes to the manufacturing process have produced large changes in a product’s immunogenicity [1].

New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. EMA is responsible for implementing the legislation and has until July 2012 to have the new system up and running [2].

The guidelines are available on the EMA website and are open for public consultation until 18 April 2012.

The seven pharmacovigilance modules are available from:

Related article

Pharmacovigilance legislation moves a step closer


1.  GaBI Online - Generics and Biosimilars Initiative. Epoetin alfa and pure red cell aplasia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 30]. Available from: www.gabionline.net/Biosimilars/Research/Epoetin-alfa-and-pure-red-cell-aplasia

2.  GaBI Online - Generics and Biosimilars Initiative. Practical guidance on new pharmacovigilance legislation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 30]. Available from: www.gabionline.net/Policies-Legislation/Practical-guidance-on-new-pharmacovigilance-legislation

Source: EMA

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