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 provide your comments using the template provided by ICH and email 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: E11A
Paediatric Extrapolation
|
Open
|
30 June 2022
|
|
Guideline Code: Q2(R2)/Q14
Analytical Procedure Development and Revision of Q2(R1) Analytical Validation
|
Open
|
30 June 2022
|
|
Guideline Code: Q9(R1)
Quality Risk Management
|
Closed
|
31 March 2022
|
|
Guideline Code: M7(R2)
Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
|
Closed
|
15 January 2022
|
|
Guideline Code: Q13
Continuous Manufacturing of Drug Substances and Drug Products
|
Closed
|
30 November 2021
|
|
Guideline Code: S12
Non-clinical Biodistribution Considerations for Gene Therapy Products
|
Closed
|
30 September 2021
|
|
Guideline Code: S1B(R1)
Rodent Carcinogenicity Studies for Human Pharmaceuticals
|
Closed
|
31 August 2021
|
|
Guideline Code: Q3D(R2)
Revision of Q3D(R1) guideline for elemental impurities for cutaneous and transdermal products
|
Closed
|
28 February 2021
|
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 adoption of ICH guidelines.