Regulator initiates EU-wide safety monitoring

If you're selling drugs in Europe, you're now less than a year away from having to submit drug data in the newly released formats developed by the European Medicines Agency. Use of the forms will be required for all drugs authorized or registered in the EU. The deadline is July 2, 2012.

The EMA describes availability of the new format as "the first milestone" in implementing its new pharmacovigilance legislation. Once original data have been submitted in the new format, drugmakers are required to maintain the information using the EudraVigilance Medicinal Product Report Message system.

The format release includes a legal notice outlining manufacturer requirements and implementation timelines. Also included is a 210-page guidance document.

The pharmacovigilance legislation was adopted in the EU in December 2010 to strengthen the Europe-wide system for monitoring drug safety. It will allow regulators to compile a list of drugs authorized in the EU, including those authorized centrally as well as those OK'd by the various regulators in EU member states.

- here's the EMA release
- see the article
- read the legal notice
- and check out the guidance

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