EMA Issues Guidance on Clarification Meetings

The European Medicines Agency (EMA) is looking to increase transparency between its committees and pharmaceutical companies under a new guideline that went into effect in February 2015.

The guideline, EMA/636600/2014, details procedures regarding clarification meetings in response to questions raised by the agency during the review of a product using the centralized procedure.

Clarifying Objections

EMA believes increasing transparency between the agency and applicants regarding objections, which can range from questions about pharmacodynamics to issues raised with a company’s risk management plan, can improve the quality of companies’ responses and reduce review times for new drugs.

The guideline covers the objectives, procedures and content of meetings between a company and relevant EMA committees to discuss the company’s response strategy to Day 120 List of Questions (LoQ) or Day 180 List of Outstanding Issues (LoOI).

In EMA’s centralized procedure an LoQ is adopted by the Committee for Medicinal Products for Human Use (CHMP) at day 120 of the procedure, detailing the committee’s questions about an application, an applicant is then able to submit a response to those questions. EMA then has until the day 180 of the procedure to review the company’s response. If further objections are raised, an LoOI is sent to an applicant at day 180.

The Meetings

According to the guideline, the response strategy meetings will be chaired by the CHMP rapporteur. Co-rapporteurs may include members of other relevant committees, such as EMA's Pharmacovigilance Risk Assessment Committee (PRAC) or Committee for Advanced Therapies (CAT). Also present will be an EMA Product Lead (EPL), whose role is to oversee a product throughout its lifecycle and “provide regulatory science input … [to] the EMA’s scientific committees."

Companies are told to submit documents detailing their response strategy, including an explanation of any points they want clarified, to the rapporteurs at least one week in advance of the meeting date.

Applicants must take minutes of the meeting, to be sent within one week to the rapporteurs and EPL for comment. The EMA then has two weeks to return a final version to the applicant. The final minutes are required to be attached to the cover letter of the company’s formal response to the agency.

Agency Disclaimer

EMA makes clear in the guideline that “these meetings are not intended to provide a pre-assessment of the Applicant’s intended responses.” Additionally, the position(s) presented by the (co-)rapporteurs will not “preempt the outcome of the assessment,” and is not binding to the committees involved.

EMA Guideline