MAA Approval Support - Overview
The European Medicines Agency (EMA) or other EU Health Authorities (HAs) might need clarification or additional information to technically review the content submitted to them through various procedures, which would be requested to MAH as day 120/150/180/210 queries. The Marketing Authorization Holders (MAHs) must address these queries with scientific inputs and justifications to avoid delays in the review cycle and expedite the Marketing Authorization Application (MAA) approval. While responding to these queries, the MAHs can consider MAA approval support for a comprehensive content review.
To ensure timely MAA submission, the applicants should notify the EMA at least seven (07) months before the planned submission date, providing an estimated submission date to the Agency. Freyr has extensive experience facilitating MAA approvals for various formulations across EU countries.
Some of the services provided by Freyr include MAA approval support, MAA Regulatory submission strategies, and the Generic Drug Approval Process in Europe.
MAA Approval Support - Expertise
- A thorough review of the deficiencies received from the EMA/other EU HAs against the registered content.
- Preparation of an action plan with responsibilities to meet the response submission timelines.
- Preparation of response strategy and guidance to the applicant on activities to be performed.
- Assessment of additional data and/or inputs and identifying the gaps.
- Preparation of response package with scientific justifications and supporting documents.
- Correspondence with the EMA/other EU HAs for extension requests and negotiation on the strategy.
