Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
IMed Consultancy Ltd
United Kingdom, Ireland
Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.
May 24, 2025
Approximately 5 minutes
Submission and Assessment Timetables for Innovative Medicines Applications in the UK
Submission and Assessment Timetables for Innovative Medicines Applications in the UK
Overview
This guidance provides timelines for submission and assessment of responses to the first Request for Information (RFI) under the UK marketing authorisation process for innovative medicines. The timetables are intended to support applicants in planning their responses and coordinating with the Commission on Human Medicines (CHM) where required.
Source: Submission and assessment timetables for innovative medicines applications - GOV.UK
MHRA Timetable Structure
The Medicines and Healthcare Products Regulatory Agency (MHRA) sets monthly submission deadlines for responses to the first RFI to help ensure consistent assessment activities and allow for CHM consultation as needed. These dates fix when the procedure restarts after a response is submitted.
Source: Submission and assessment timetables for innovative medicines applications - GOV.UK
Example Timeline Summary
The official guidance lists submission deadlines, procedure restart dates, and estimated CHM meeting and second RFI timepoints for applicants to follow. For example:
- Submission deadline: 02/01/2026 → Procedure restart: 05/01/2026 → CHM meeting: 26/02/2026 → Second RFI or CHM letter: 05/03/2026
- Submission deadline: 30/01/2026 → Procedure restart: 02/02/2026 → CHM meeting: 26/03/2026 → Second RFI: 02/04/2026
(… and further monthly entries are provided in the timetable.)
Source: Submission and assessment timetables for innovative medicines applications - GOV.UK
Purpose of the Timetables
The timetables help applicants understand when to submit responses to RFIs, when the regulatory clock restarts, and when key CHM interactions or follow-up information requests are expected. This enables transparency for timelines to resolve questions about quality, safety, or efficacy during the review.
Source: Submission and assessment timetables for innovative medicines applications - GOV.UK
Planning Your Response
Applicants should prepare RFI responses as eCTD sequences (electronic Common Technical Document) and submit before the relevant deadline to avoid delays. The MHRA restarts the assessment clock 3 calendar days after submission.
Source: related MHRA guidance context
Next Steps After Timetables
Once responses are assessed, the MHRA may issue a second request for information or a CHM letter if significant issues remain. Final marketing authorisation decisions may follow later in the national assessment procedure.
Source: related MHRA guidance context
Have a Question?
Ask our experts about this topic. We'll do our best to respond to your question.