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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Find out about the collaborations with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Overview

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry, through scientific and technical discussions; to achieve greater harmonisation worldwide in ensuring that safe, effective, and high quality medicines are developed and registered efficiently. For more information on ICH, please refer to the ICH Official Website.

The Health Sciences Authority (HSA) has been an observer to the ICH platform since 2007. HSA was accepted as a Regulatory Member of the ICH in November 2017 (see press release) and was elected as part of the ICH Management Committee (MC) in June 2018. These marked a significant milestone for HSA as we gained international recognition as a country with an advanced regulatory system for pharmaceutical products. As a Regulatory member, HSA will have first rights to participate in ICH expert and implementation working groups (EWGs and IWGs), to influence decision-making in pharmaceutical product development and registration, and to vote on all matters raised at the ICH meetings.

ICH Guidelines for Consultation

In accordance with the ICH process of Harmonisation, the Formal ICH Procedure is followed for the harmonisation of all new ICH topics. The procedure includes regulatory consultation to be conducted by ICH Members to seek stakeholder's feedback on the proposed draft guidelines or FAQs developed by the ICH EWGs/IWGs. Feedback received are forwarded to the relevant ICH EWGs/IWGs for consideration. The finalised guidelines are then endorsed at the ICH Assembly prior to publication on the ICH website.

Your feedback is important and contributes towards the finalisation of the ICH guidelines.

Please email them to HPRG_feedback@hsa.gov.sg with the subject title: ICH <Guideline Code> Feedback.

Draft ICH Guidelines             

Status for consultation

Deadline for comments

Guideline Code: M7(R2)

Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Closed

1 September 2020

Guideline Code: Q3C(R8) 

Maintenance of the Guideline for Residual Solvents

Closed

3 June 2020

Guideline Code: E8(R1)

Revision on General Considerations for Clinical Trials

Closed

30 September 2019

Guideline Code: E19

Optimisation of Safety Data Collection

Closed

31 July 2019

Guideline Code: M10

Bioanalytical Method Validation

Closed

1 July 2019

Guideline Code: S11

Non-clinical Safety Testing in Support of Development of Paediatric Medicines

Closed

1April 2019

Guideline Code: M9

Biopharmaceutics Classification System-based Biowaivers

Closed

26 October 2018

Guideline Code: Q12

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Annex (draft)

Closed

26 October 2018

Timelines for local adoption and implementation of the ICH guidelines

The timelines for the adoption and implementation of ICH guidelines by HSA will take into consideration the need to undertake certain activities including training, change in business and IT processes, resourcing, expertise, and/or regulatory/legislative amendments. The potential impact on our stakeholders and their preparedness are also key considerations towards the local implementation of ICH guidelines. Stakeholders will be informed timely on the implementation of the ICH guidelines.

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