# Submission and assessment timetables for innovative medicines applications Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/d388760b-c901-43bd-98e1-9459bf59b19f Type: Detailed Guide Published: April 2, 2025 Updated: January 27, 2026 > This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the national assessment procedure for Marketing Authorisation (MA) applications for innovative medicines. The regulatory framework applies to pharmaceutical companies seeking to market new active substances, biological products, vaccines, biosimilars, and orphan medicinal products. The guidance establishes a structured assessment timetable to facilitate consultation with the Commission on Human Medicines (CHM). Key required actions include the submission of a pre-submission notification form at least three months prior to the intended application date. For companies developing new active substances or biological products, the MHRA strongly recommends holding pre-submission meetings. All application dossiers and responses to the first Request for Information (RFI) must be submitted electronically via the MHRA submissions portal. The document provides detailed deadlines for procedures starting between November 2025 and September 2028. As this is a guidance document rather than an enforcement action, there are no specific company violations or inspection dates listed; however, it clarifies that applications failing validation by the procedure start date will be deferred to the next cycle. This framework ensures a predictable and rigorous review process for innovative treatments within the UK market. --- ## Content 1. Introduction This guidance should be read alongside our guidance on the MHRA’s national assessment procedure for marketing authorisation (MA) applications . We operate fixed submission and assessment timetables for innovative medicines MA applications to facilitate consultation with the Commission on Human Medicines ( CHM ). Innovative medicines applications are defined as applications for: New active substances (NAS), defined as active substances that have not been authorised in a medicinal product in the UK before All biological products (derived or manufactured from a living biological system) including advanced therapy medicinal products (ATMPs), vaccines and biosimilars New combinations of existing active substances Orphan medicinal products Conditional MA or MA under exceptional circumstances Line extensions of any of the above (for example, addition of strengths, pharmaceutical forms or routes of administration) You should notify us of your intended submission date at least 3 months in advance, by completing the pre-submission notification form . If you are planning to submit a national MA application for a NAS, or a biological product including a biosimilar, we strongly recommend that you request a pre-submission meeting using the notification form. 2. Deadlines for initial submissions The MA application dossier should be submitted through the MHRA submissions portal on or before the deadline (DD/MM/YYYY) as detailed below. Submission deadline Procedure start date* (Day0) CHM meeting (Day83) First RFI (Day90) 14/11/2025 05/12/2025 26/02/2026 05/03/2026 12/12/2025 02/01/2026 26/03/2026 02/04/2026 09/01/2026 30/01/2026 23/04/2026 30/04/2026 06/02/2026 27/02/2026 21/05/2026 28/05/2026 13/03/2026 03/04/2026 25/06/2026 02/07/2026 17/04/2026 08/05/2026 30/07/2026 06/08/2026 15/05/2026 05/06/2026 27/08/2026 03/09/2026 12/06/2026 03/07/2026 24/09/2026 01/10/2026 17/07/2026 07/08/2026 29/10/2026 05/11/2026 14/08/2026 04/09/2026 26/11/2026 03/12/2026 04/09/2026 25/09/2026 17/12/2026 24/12/2026 09/10/2026 30/10/2026 21/01/2027 28/01/2027 06/11/2026 27/11/2026 18/02/2027 25/02/2027 04/12/2026 25/12/2026 18/03/2027 25/03/2027 08/01/2027 29/01/2027 22/04/2027 29/04/2027 05/02/2027 26/02/2027 20/05/2027 27/05/2027 05/03/2027 26/03/2027 17/06/2027 24/06/2027 09/04/2027 30/04/2027 22/07/2027 29/07/2027 07/05/2027 28/05/2027 19/08/2027 26/08/2027 04/06/2027 25/06/2027 16/09/2027 23/09/2027 09/07/2027 30/07/2027 21/10/2027 28/10/2027 06/08/2027 27/08/2027 18/11/2027 25/11/2027 03/09/2027 24/09/2027 16/12/2027 23/12/2027 15/10/2027 05/11/2027 27/01/2028 03/02/2028 12/11/2027 03/12/2027 24/02/2028 02/03/2028 17/12/2027 07/01/2028 30/03/2028 06/04/2028 14/01/2028 04/02/2028 27/04/2028 04/05/2028 11/02/2028 03/03/2028 25/05/2028 01/06/2028 17/03/2028 07/04/2028 29/06/2028 06/07/2028 14/04/2028 05/05/2028 27/07/2028 03/08/2028 12/05/2028 02/06/2028 24/08/2028 31/08/2028 16/06/2028 07/07/2028 28/09/2028 05/10/2028 14/07/2028 04/08/2028 26/10/2028 02/11/2028 11/08/2028 01/09/2028 23/11/2028 30/11/2028 08/09/2028 29/09/2028 21/12/2028 28/12/2028 *If the application is not validated by this date, the next procedure start date will apply 3. Deadlines for responses submissions Our submission and assessment timetables include monthly submission deadlines for your response to the first request for information ( RFI ). This is to facilitate further consultation with the CHM if required. The responses dossier should be submitted through the MHRA submissions portal on or before the deadline (DD/MM/YYYY) as detailed below. There are no fixed submission dates for your responses to the second or third RFI . Submission deadline Procedure restart date (Day 91) CHM meeting (Day 143) Second RFI or CHM letter (Day 150) 02/01/2026 05/01/2026 26/02/2026 05/03/2026 30/01/2026 02/02/2026 26/03/2026 02/04/2026 27/02/2026 02/03/2026 23/04/2026 30/04/2026 27/03/2026 30/03/2026 21/05/2026 28/05/2026 01/05/2026 04/05/2026 25/06/2026 02/07/2026 05/06/2026 08/06/2026 30/07/2026 06/08/2026 03/07/2026 06/07/2026 27/08/2026 03/09/2026 31/07/2026 03/08/2026 24/09/2026 01/10/2026 04/09/2026 07/09/2026 29/10/2026 05/11/2026 02/10/2026 05/10/2026 26/11/2026 03/12/2026 23/10/2026 26/10/2026 17/12/2026 24/12/2026 27/11/2026 30/11/2026 21/01/2027 28/01/2027 25/12/2026 28/12/2026 18/02/2027 25/02/2027 22/01/2027 25/01/2027 18/03/2027 25/03/2027 26/02/2027 01/03/2027 22/04/2027 29/04/2027 26/03/2027 29/03/2027 20/05/2027 27/05/2027 23/04/2027 26/04/2027 17/06/2027 24/06/2027 28/05/2027 31/05/2027 22/07/2027 29/07/2027 25/06/2027 28/06/2027 19/08/2027 26/08/2027 23/07/2027 26/07/2027 16/09/2027 23/09/2027 27/08/2027 30/08/2027 21/10/2027 28/10/2027 24/09/2027 27/09/2027 18/11/2027 25/11/2027 22/10/2027 25/10/2027 16/12/2027 23/12/2027 03/12/2027 06/12/2027 27/01/2028 03/02/2028 31/12/2027 03/01/2028 24/02/2028 02/03/2028 04/02/2028 07/02/2028 30/03/2028 06/04/2028 03/03/2028 06/03/2028 27/04/2028 04/05/2028 31/03/2028 03/04/2028 25/05/2028 01/06/2028 05/05/2028 08/05/2028 29/06/2028 06/07/2028 02/06/2028 05/06/2028 27/07/2028 03/08/2028 30/06/2028 03/07/2028 24/08/2028 31/08/2028 04/08/2028 07/08/2028 28/09/2028 05/10/2028 01/09/2028 04/09/2028 26/10/2028 02/11/2028 29/09/2028 02/10/2028 23/11/2028 30/11/2028 27/10/2028 30/10/2028 21/12/2028 28/12/2028 4. Contact For further information, email RIS.NA@mhra.gov.uk .