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Registrar Corp
維吉尼亞州漢普頓 (總部), 中國深圳, 英國倫敦, 法國巴黎, 西班牙馬德里, 印度海得拉巴, 馬來西亞吉隆坡, 以色列特拉維夫, 瓜地馬拉瓜地馬拉市, 南非開普敦
000 家企業處理 FDA 註冊、美國代理人要求、標籤合規及扣留協助等事務。我們提供包含 FDA 合規監控器 (Compliance Monitor) 和不良事件管理軟體在內的技術解決方案，協助食品、飲料、醫療器材、藥品和化妝品行業的企業應對複雜的法規環境。
MedEnvoy Global
荷蘭海牙, 英國倫敦, 美國, 瑞士, 澳洲
一家全球法規合規合作夥伴，專注於為醫療器材和 IVD 製造商提供在地代表（EC Rep、UKRP、CH Rep、美國代理人）和獨立進口商服務。我們協助企業應對歐洲、英國、瑞士和美國的複雜法規，同時保持供應鏈的靈活性。
KoBridge Co Ltd
韓國首爾, 瑞士洛桑
我們為需要應對日益複雜的全球法規的醫療器材製造商提供快速、有效和靈活的解決方案。他們的核心能力涵蓋 CE 標誌、FDA 510(k)/PMA、MDSAP，尤其是韓國 MFDS 註冊和 KGMP 合規性。他們處理主動、非主動、組合和動物源性設備，提供從策略規劃和文件準備到品質系統實施 (ISO 13485) 和稽核的服務。
IMed Consultancy Ltd
英國, 愛爾蘭
幫助醫療器械和體外診斷公司進行 CE 標記、品質管理系統、審計和全球註冊。
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
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