Pre-submission Advice & Support

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) offers a structured pre-submission service to support companies seeking Marketing Authorisations for medicines in the United Kingdom. This guidance outlines the framework for prospective applicants to obtain advice on compiling and submitting their applications. A critical requirement is that companies intending to submit applications for New Active Substances or Biological products must request a pre-submission meeting at least three months prior to their planned application date. This mandatory notification also applies to new indications and line extensions. For applicants using the International Recognition Procedure, Project Orbis, or the Access Consortium, specific notification protocols are required to ensure efficient coordination. The process involves submitting standardized forms to a dedicated MHRA team, which then triages the requests to provide written advice, direct guidance, or formal meetings. By facilitating early engagement, the MHRA aims to clarify evidence requirements and streamline the regulatory pathway for complex medical products. This service is distinct from the agency's scientific advice and is intended to help stakeholders navigate the procedural aspects of the UK’s medicine registration system.