EMA Clarifies Procedures for Reporting Adverse Events and Submitting Study Protocols

European regulators last week released two guidelines clarifying certain requirements for pharmacovigilance in the EU.

A draft guideline on postauthorization safety studies describes procedures for reporting adverse events and submitting study protocols. If suspected adverse events resulting in death are not subject to expedited reporting as individual case safety reports, drugmakers should explain their rationale for not reporting them, the European Medicines Agency says.

Study protocols should include procedures for collecting, managing and reporting adverse events, according to Module VIII – Post-Authorisation Safety Studies (Rev 2). The draft also clarifies that the EMA or a national competent authority can require drugmakers to conduct postauthorization safety studies if there are risk concerns.

An addendum accompanying the draft contains new information on how study protocols and reports on noninterventional postauthorization safety studies should be reported to member states. Trial protocols and reports for centrally authorized products should always be sent to the EMA.

A final guideline, Module IV – Pharmacovigilance Audits (Rev 1), clarifies when activities don’t require an audit.

Comments on the draft guideline and addendum are due Oct. 9. They will take effect in the first quarter of 2016. Read the documents at www.fdanews.com/8-15-EMA-PASS1.pdf and www.fdanews.com/8-15-EMA-PASS2.pdf. The guidance on pharmacovigilance audits is available at www.fdanews.com/08-12-15-audit.pdf. — Jonathon Shacat