Rolling review for marketing authorisation applications

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has outlined a "rolling review" pathway for marketing authorisation applications, specifically targeting new active substances and biosimilars. This route facilitates the incremental submission of data modules—covering quality, non-clinical, and clinical findings—rather than a single consolidated dossier. Governed by the Human Medicines Regulations 2012, the process will transition to a UK-wide scope starting January 1, 2025, following the implementation of the Windsor Framework. To participate, applicants must engage in a pre-submission meeting with the MHRA approximately 90 days before the final application and complete a paediatric compliance check 60 days before submission. Each module undergoes a 60-day assessment cycle, after which the regulator provides feedback to help refine the final application. The final assessment phase follows a 100-day timeline, divided into a 60-day initial review and a 40-day conclusion after addressing any requests for further information. This streamlined approach is designed to enhance regulatory interaction, reduce the risk of development failure, and accelerate the availability of innovative medicines. Failure to follow these procedural steps or provide sufficient data during the modular phases may lead to delays or the refusal of the authorisation.