EU to Release New Guideline on Risk Management Plans

The European Medicines Agency expects to release a revised draft GMP guideline and template for risk management plans in October.

The updated Module V — one of 16 chapters in a broader pharmacovigilance guideline — will define “risk management plan” and align risk definitions with the International Conference on Harmonisation. The risk definitions will provide clarity on what is important and what is not, Eli Lilly’s Valerie Simmons told a session at the DIA annual meeting in Washington, D.C.

The guideline’s focus is on evidence-based risk identification, Simmons said. RMPs should be driven by data, not procedure type, taking into account the seriousness of events, their frequency and the patient and benefit/risk impacts to establish an association between certain events and the drug.

RMP submissions are required only with the initial marketing authorization application and when safety specifications, pharmacovigilance or risk-management activities change. Marketing authorization holders should consider updating their RMPs after submitting new data to the EMA.

When creating an RMP, companies should use available data and plan for the future by considering the drug product’s life cycle. A wide net should be cast to capture potential safety concerns at the approval stage, Simmons said.

New information about major risks or missing information should be added once scientific evidence confirms it and preferably at key stages in the authorization process, such as the first renewal at five years postauthorization or the first periodic safety update report following renewal. Simmons pointed out that an important potential risk can become an important identified risk after data confirms it. Likewise, an important potential risk can be removed if data fails to confirm concerns.

The guideline also provides guidance on postauthorization safety studies, noting that only those required or requested by the EMA’s Pharmacovigilance Risk Assessment Committee or Committee for Medicinal Products for Human Use should be included in the risk-management plan. — Kellen Owings