Health Authority Interactions in Europe - Overview
Health Authority interactions in Europe help in drug product approvals and can have a positive impact on the approval timelines and overall costs. This can include Regulatory agency interactions with the European Medicines Agency (EMA) and other regional Health Authorities (HAs) for EU and non-EU countries).
Contact with HAs (whether in writing, via teleconference, or face-to-face) must be conducted efficiently throughout the Regulatory process and lifecycle of a product. Health Authority interactions such as EMA pre-submission meetings and scientific advice meetings require careful planning so that they are requested at the most appropriate time and address all those points that enable applicants to proceed with their submissions.
Understanding HA expectations and identifying potential risks and weaknesses with Regulatory submission strategies are essential. Furthermore, preparing for appropriate risk-mitigation strategies can help minimize potential delays in Regulatory approval.
Freyr’s team is experienced in planning for Health Authority interactions/meetings and preparing the documentation required to make them successful. A thorough evaluation of the outcome of such meetings helps ensure that the Regulatory strategies are in line with the HA recommendations. Knowledge of different dosage forms, types of Regulatory submissions, and a proven track record in providing Regulatory support have made Freyr a preferred partner to global companies in supporting their initial and EMA pre-submission meetings and post-approval maintenance changes.
Health Authority Interactions in Europe - Freyr Expertise
Regulatory support for all types of medicinal product licenses (e.g., National, MRP, DCP, and Centralized).
HA query evaluation (including a review of the Regulatory submission to which the query relates to).
Support in the preparation and execution of HA query-response strategies.
Preparation of HA response documents, including relevant scientific justifications.
Assessment of submission documentation, including initial applications and post-approval submissions (e.g., initial validation comments, response to the completeness assessment report, and response to the Information Requests [IRs]).
Assessment of post-approval submissions (e.g., variations of Types IA, IA, IB, and Type II, line extension applications, etc.).
Country-specific administrative data (Module 1) requirements.
Support in case of application rejection by Regulatory authorities.
Requesting scientific advice from the Regulatory authority before/during the submission.
Coordination and preparation support for HA scientific advice meetings.
EMA pre-submission communications (e.g., related to the formulation, Regulatory strategy, etc.).