CHMP Oral Explanation
High quality assistance from true experts to plan the initial MAA submission strategy as well as support to address critical MAA issues.
The EMA manages the Centralised Procedure for the evaluation of Marketing Authorisation Applications (MAA). The EMA’s Committee of Human Medicinal Products (CHMP) assesses whether a product fulfils the EU requirements to be approved, and whether its benefits outweigh its risks. The procedure lasts a maximum of 210 Days, excluding clock stop periods, until an opinion is issued by CHMP.
At Day 120 of the procedure there will be the first consolidated List of Questions (LoQ) on the MAA and the clock will stop for up to three months (with a possible extension to six) so that the Applicant can provide answers to the LoQ. After submission of the answers the procedure clock will start again.
On Day 180 the CHMP discusses the Joint Assessment Report and the List of Outstanding Issues (LoOI) for unresolved matters. The most important task is to identify the Major Objections, which may lead to a refusal of the MAA if they are not resolved.
At that point, the CHMP can request the involvement of a Scientific Advisory Group (SAG), where the Applicant is given the opportunity to present data supporting the application and addressing the specific questions addressed by the CHMP to the SAG.
If the outstanding issues remain, an Oral Explanation (OE) may be requested by the EMA, where the Company must attend the CHMP plenary session and address the Major Objections related to approval of the MAA. The CHMP members can then question the Applicant on the key issues and thereafter will decide on whether to adopt a positive or negative opinion. The final opinion will be then issued on Day 210.
Kinesys Regulatory Advisory Board Assistance
Kinesys Regulatory Advisory Board provides high quality assistance on planning the initial MAA submission strategy as well as support for critical issues, including Major Objections and a potential Oral Explanation. Our extensive network of experts, selected from former regulators and highly experienced industry executives, covers all technical and regulatory aspects that might require resolution in order to reassure CHMP and drive the Application towards a positive opinion.
An OE is a critical event during any MAA procedure, and this is where our network can make a real difference. Extensive preparation is required for this key meeting with CHMP as it may well be the defining moment in a development programme that has lasted at least 10 years and cost hundreds of millions of dollars.
Kinesys Regulatory Advisory Board will thoroughly review the questions and issues raised in the LoQ and LoOI, provide strategic and communication advice and topic-specific experts as needed.
Kinesys Regulatory Advisory Board usually conducts a mock CHMP meeting with rigorous preparation of all key aspects for the OE. This includes how best to communicate orally at the OE meeting, and how to write key elements of the responses of the Applicant to issues raised by CHMP, in order to ensure a successful outcome. The mock OE is designed to challenge the Applicant in an environment that simulates how the real OE will be conducted, thus preparing the Applicant’s OE presentation team not only in their scientific responses, but psychologically to the typical CHMP methodology and approach.