MTS Helpdesk
Question:
When do I have to start following the updated ICH guideline, Q2(R2) and the new guideline, Q14?
Answer:
The step 4 adoption of both the updated Q2(R2) and the new Q14 by ICH was achieved in November 2024 and therefore the current status of both of the guidelines is step 5. This is the regulatory implementation step and is carried out according to the same national or regional procedures that apply to other regional regulatory guidelines and requirements in the ICH regions.
Information on the regulatory action taken and implementation dates are reported back to the assembly and published by the ICH secretariat on the ICH website. Therefore, the implementation status of ICH guidelines in particular regions may be found on the ICH website.
It would be advisable to start to follow the new guidelines immediately in anticipation of full implementation in your region.
At time of writing, the status was as follow:
ICH Q2(R2):
ANMAT, Argentina – Not yet implemented;
ANVISA, Brazil – Not yet implemented;
COFEPRIS, Mexico – Implemented; Date: 25 February 2022; Reference: Pharmacopeia of the United Mexican States 13.0.
EC, Europe – Implemented; Date: 14 June 2024; Reference: EMA/CHMP/ICH/82072/2006
EDA, Egypt – Implemented; Date: 1 June 2024; Reference: (Guidelines for File Assessment for Pharmaceutical Products for Human Use) and (Regulatory Guide for mechanisms, procedures and rules of implementing the Decree of Egyptian Drug Authority No.343 of 2021)
FDA, United States – Implemented; Date: 7 March 2024; Reference: 89 FR 16582
HSA, Singapore – Implemented; Date: 1 August 2025;
Health Canada, Canada – Implemented; Date: 15 October 2025; Reference: File #: 25-105890 – 674
JFDA, Jordan – Not yet implemented;
MFDS, Republic of Korea – In the process of implementation; Date: 1 December 2026;
MHLW/PMDA, Japan – Implemented; Date: 9 October 2025; Reference: PSB/ PED Notification No. 1009-1
MHRA, UK – Not yet implemented;
NMPA, China – Implemented; Date: 24 November 2024; Reference: NMPA, China Announcement No.65(2024)
SFDA, Saudi Arabia – Implemented; Date: 22 September 2011;
Swissmedic, Switzerland – Implemented; Date: 1 November 2023; Reference: ICH Guidelines apply in Switzerland automatically upon reaching Step 4: Swissmedic Journal 05/2006, p. 504
TFDA, Chinese Taipei – In the process of implementation;
TITCK, Türkiye – Implemented; Date: 22 January 2024; Reference: Q2 is referred to in Guidelines on Chemical and Pharmaceutical Quality Requirements for Investigational Medicinal Products for Human Use in Clinical Trials and Guideline on Requirements for Quality of Biological İnvestigational Medicinal Products in Clinical Trials
ICH Q14:
ANMAT, Argentina – Implemented; Date: 17 October 2023; Reference: ANMAT Regulation 4061/2023
ANVISA, Brazil – Not yet implemented;
COFEPRIS, Mexico – Not yet implemented;
EC, Europe – Implemented; Date: 14 June 2024; Reference: EMA/CHMP/ICH/195040/2022
EDA, Egypt – Implemented; Date: 25 September 2024; Reference: Regulatory guide for mechanisms, procedures and rules of implementing the decree of Egyptian Drug Authority No.343 of 2021
FDA, United States – Implemented; Date: 7 March 2024; Reference: 89 FR 16582
HSA, Singapore – In the process of implementation;
Health Canada, Canada – Implemented; Date: 12 January 2026; Reference: File #: 25-105890-674
JFDA, Jordan – Not yet implemented;
MFDS, Republic of Korea – In the process of implementation; Date: 1 December 2027;
MHLW/PMDA, Japan – Implemented; Date: 9 October 2025; Reference: PSB/ PED Notification No. 1009-2
MHRA, UK – In the process of implementation;
NMPA, China – Implemented; Date: 24 November 2024; Reference: NMPA, China Announcement No.65(2024)
SFDA, Saudi Arabia – Not yet implemented;
Swissmedic, Switzerland – Implemented; Date: 1 November 2023; Reference: ICH Guidelines apply in Switzerland automatically upon reaching Step 4: Swissmedic Journal 05/2006, p. 504
TFDA, Chinese Taipei – Not yet implemented;
TITCK, Türkiye – Implemented; Date: 17 July 2017; Reference: Guideline for Stability Testing of Active Ingredients and Finished Products
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Related content from our Resources Library
MTS offers a short course, ‘What’s New in ICH Q2(R2) and Q14?‘, which fully explores the updates to Q2 in terms of the additional information that has been introduced, and the expected benefits, the potential additional validation requirements and associated gap assessment, when compared to previous requirements, and also to provide an overview of the contents of Q14 and how this new guideline relates to Q2(R2).
A full discussion of analytical procedure lifecycle management is included in our courses, ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘, and ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘.
Visit our courses page for a full list of available courses and the schedule of currently available course dates.