ICH updates: E14 consultation, Health Canada implements M9 guideline

Regulatory NewsRegulatory News | 28 August 2020 |  By 

The International Council for Harmonisation (ICH) on Thursday announced its E14/S7B draft questions and answers guideline on clinical and nonclinical evaluation of QT/QTc interval and proarrhythmic potential has reached Step 2b of the ICH process.
On Friday, the European Medicines Agency (EMA) opened a three-month public consultation to gather feedback on the document. ICH will also be hosting a two-day public meeting to provide a high-level overview of the document in October.
EMA also released a report from its meeting in June to gather input from patients, healthcare professionals and researchers to inform an upcoming review to ICH’s good clinical practice (GCP) guideline, ICH E6(R3).
Earlier this week, Health Canada announced it has implemented both ICH M9: Biopharmaceutics Classification System (BCS)-Based Biowaivers, which provides a harmonized approach to biopharmaceutics classification of drugs and provides recommendations for when bioequivalence studies can be waived, and its accompanying questions and answers document.
Health Canada explains that the M9 guideline replaces its previous national-level guidance on BCS-based biowaivers and instructs drugmakers to complete its BCS-based biowaiver evaluation template for any submissions that include a biowaiver request.
Earlier this month, ICH released an introductory training presentation for the recent ICH S11 guideline and an updated user guide for ICH E2B(R3). (RELATED: ICH adopts S11 guideline on nonclinical safety testing for pediatric drugs, Regulatory Focus 14 April 2020; Health Canada adopts ICH pediatric drug development guidance, Regulatory Focus 20 August 2020).


© 2022 Regulatory Affairs Professionals Society.

Tags: Canada, E14, EU, ICH, M9

Discover more of what matters to you

No taxonomy