Medical Translation Insight

The European Medicines Agency (EMA) is planning for the implementation of new pharmacovigilance legislation in July this year. The new rules (Directive 2010/84/EU [PDF link] and Regulation (EU) No. 1235/2010 [PDF link]) amend existing legislation and was adopted back in December 2010.

The main goal of the legislation is to strengthen the EU-wide system for monitoring the safety and benefit-risk balance of medicines. Four key areas will be targeted in the legislation (from PharmTech.com):

1. Collection of key medicines' information: Activities in this area will include strengthening procedures for submitting risk-management plans to the EMA, as well as the need for marketing-authorization holders to provide periodic safety update reports (PSURs).
2. Better analysis and understanding of data and information: Throughout 2012, EMA will be investing in new information technology systems and signal-detection tools. In particular, the agency aims to strengthen its side-effects collection system, EudraVigilance, by adding increased functionality and improving data quality.
3. Regulatory action to safeguard public health: Starting in July 2012, a new pharmacovigilance risk assessment committee will begin meeting, stepping up to monthly meetings from September 2012.
4. Communication with stakeholders: Transparency is explicit in the legislation and will lead to the online publishing of information, such as agendas from committee meetings, assessments, approvals, recommendations, and opinions, on EMA's website.

For more details, check out this helpful Q&A document [PDF link] and look for pharmacovigilance topics on FXConferences.com!

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