Submission and assessment timetables for innovative medicines applications
Guidance on the deadlines for initial and response submissions.
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* (Day 0) | CHM meeting (Day 83) | First RFI (Day 90) |
|---|---|---|---|
| 11/04/2025 | 02/05/2025 | 24/07/2025 | 31/07/2025 |
| 16/05/2025 | 06/06/2025 | 28/08/2025 | 04/09/2025 |
| 16/06/2025 | 07/07/2025 | 28/09/2025 | 05/10/2025 |
| 18/07/2025 | 08/08/2025 | 30/10/2025 | 06/11/2025 |
| 15/08/2025 | 05/09/2025 | 27/11/2025 | 04/12/2025 |
| 05/09/2025 | 26/09/2025 | 18/12/2025 | 25/12/2025 |
| 17/10/2025 | 07/11/2025 | 29/01/2026 | 05/02/2026 |
| 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 |
*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) |
|---|---|---|---|
| 04/08/2025 | 07/08/2025 | 28/09/2025 | 05/10/2025 |
| 05/09/2025 | 08/09/2025 | 30/10/2025 | 06/11/2025 |
| 03/10/2025 | 06/10/2025 | 27/11/2025 | 04/12/2025 |
| 24/10/2025 | 27/10/2025 | 18/12/2025 | 25/12/2025 |
| 05/12/2025 | 08/12/2025 | 29/01/2026 | 05/02/2026 |
| 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 |
4. Contact
For further information, email RIS.NA@mhra.gov.uk.