Pre-submission Advice & Support for Innovative Medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations and clinical variations innovative medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service to support prospective applicants before submission of applications. This service aims to provide appropriate support to applicants, regardless of the application route.

For the purposes of this guidance, Innovative Medicines refer to new chemical active substances, all biological medicines (including biosimilars), medicines for orphan indications, medicines for rare diseases, and products seeking conditional approval or approval under exceptional circumstances.

Applicants intending to submit such applications must notify the MHRA of their intended submission date in advance, as outlined below.

Applicants may also request a pre-submission meeting to support preparation for a planned submission. These meetings are intended to support procedural and regulatory aspects and MHRA’s operational planning while providing an opportunity to introduce the product and planned submission approach to the MHRA.

Where a pre-submission meeting is not requested, but the MHRA deem it required, a pre-submission meeting is strongly advised prior to submission to ensure that appropriate expertise and resources are in place and to identify any procedural or logistical issues that could affect the handling of the application. Applicants are strongly encouraged to attend any pre-submission meeting requested by the MHRA. Failure to do so may increase the risk of validation issues or delayed validation and subsequent assessment of the application.