EMA Updates Guidance for Sponsors Seeking Postmarket Scientific Advice

The European Medicines Agency updated its guidance on post-authorization procedures, including recommendations for sponsors to voluntarily seek scientific advice.

Applicants and marketing authorization holders are encouraged to request scientific advice from the EMA on specific aspects of study protocols, especially for complex or controversial issues as well as innovative methodologies, the agency said.

The agency’s advice can support proactive pharmacovigilance planning and help develop a well-defined procedural timetable, as well as offer pre-submission interactions in face-to-face meetings with regulators and patient representatives, the EMA said.

The EMA also suggested that sponsors seek scientific advice when conducting postmarket safety studies not required by regulations. Clinical data submitted in support of expansion of indications will be published on the EMA’s website, the agency announced.