Executive Briefing Series (formerly The Food & Drug Letter)

The European Medicines Agency (EMA) has issued new guidance on key information drugmakers must submit to support the safety monitoring of all medicines authorized and registered in the EU, whether at the centralized or national level.

Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline.

Under new drug safety regulations, drugmakers must have a quality system covering the organizational structure, responsibilities, procedures, processes and resources of their pharmacovigilance system.

Drugmakers must report serious adverse drug reactions within 15 days of having received an individual case safety report (ICSR), and nonserious reactions within 90 days, according to guidance on the EU’s new pharmacovigilance regulations.

For the first time, high-risk drugs subject to special monitoring must carry a “black symbol” in the product labeling.

Companies may find it easier to submit risk management plans (RMP) to different regulatory authorities in the EU, thanks to a new modular format unveiled by the European Medicines Agency (EMA) and Heads of Medicines Agencies.

The European Medicines Agency (EMA) could require multiple drugmakers to conduct a joint post-authorization safety study (PASS) if concerns about the risk of a particular compound apply to more than one drug, according to the agency.