EMA Phasing Out Follow-Up Measures
Posted 02 August 2012 | By
The European Medicines Agency (EMA) is phasing out so-called "follow-up measures" for human drugs requiring post-marketing studies this month, instead replacing them with three categories of post-marketing commitments:
- Conditions in Annex II (obligations or specific obligations to fulfil post-authorization measures);
- Additional pharmacovigilance activities in the risk-management plan;
- Recommendations for further development.
The old "follow-up measures" established studies and other activities that the European Medicines Agency and the Committee for Human Medicinal Products had asked the marketing authorization holder to perform.
This new system of classification is being implemented in stages. The first phase tackled initial marketing-authorization-application opinions as of June 2011, followed by post-authorization procedures starting in November 2011. Companies affected by the new classification changes will receive an outcome fax for each applicable product that will include information about the new classification of follow-up measures, together with any actions that they need to take.
EMA - European Medicines Agency phasing out follow-up measures
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