Hybrid Applications - Overview
Registration of the Marketing Authorization Application (MAA) for a generic product with changes in active substance(s), therapeutic indications, strength, and route of administration compared to the reference medicinal product is very complex as the MAA relies on pre-clinical and clinical trial data concerning the reference product and new data. In such a scenario, bridging studies are critical to show the equivalency with the reference medicinal product for on-time registration and receipt of approval for hybrid application through Article 10(3) from EMA/EU Health Authorities.
Freyr, with wide experience in handling MAA submissions for hybrid applications (Article 10(3)), acts as a cost-effective and trust-worthy Regulatory partner to pharmaceutical manufacturers/Marketing Authorization Holders (MAHs) in order to handle all legal and administrative requirements, along with registration activities, for the medicinal products.
Hybrid Applications - Expertise
- Preparation and review of study designs to be performed for bridging studies
- Pre-submission meetings with the EMA or with other EU Health Authorities
- Preparation and support of submission packages for scientific meetings with the EMA/EU Health Authorities
- Regulatory submission road map/way forward for generic and hybrid applications
- Selection of dissolution parameters/multimedia for performance of dissolution for test product and RMP
- Support in the preparation of product development report (discriminatory nature of media)
- Finalizing the specifications for finished products, in-process/intermediates and review of protocols/reports for exhibit batches/stability study
- Assistance in selection of Regulatory submission procedure i.e. Centralized Procedure (CP), National Procedure (NP), Decentralized Procedure (DCP) or Mutual Recognition Procedure (MRP)
- Slot booking for MAA submissions
- Liaise with country HA to act as RMS for MAA filing in DCP
- Technical gap analysis of source documents/data for adequacy against EU countries specific requirements
- Compilation, technical review, finalization, publishing and MAA submissions in eCTD format
- Regular follow-ups with Health Authorities
- Handling Health Authority (HA) queries with strategies and preparation of response package for submission for marketing authorization approval
- Translation support during the national phase of the registration in all EU languages
