International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
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 Guideline(s)||Document
(Click to Download)
|Deadline for comments|
Guideline Code: Q12
Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
|26 October 2018|
Guideline Code: M9
M9: Biopharmaceutics Classification System-based Biowaivers
|[M9 Draft Guideline]||26 October 2018|
Guideline Code: S11
S11: Non-clinical Safety Testing in Support of Development of Paediatric Medicines
|[S11 Draft Guideline]||1 April 2019|
Guideline Code: M10
M10: Bioanalytical Method Validation
|[M10 Draft Guideline]||1 July 2019|
Guideline Code: E19
E19: Optimisation of Safety Data Collection
|[E19 Draft Guideline]||31 July 2019|
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.