Regulatory update: Spring 2022
25 April 2022
Clinical Trials BC Chronicle Spring 2022 – by Jean Smart, regulatory affairs & quality officer, Clinical Trials BC
Health Canada – Modernization Update
Health Canada’s anticipated What we Heard consultation document on the Regulatory Modernization of clinicalj trials in was made available on March 3, 2022. You can find it at the link below. This report summarizes the comments and responses that were received during this an extensive stakeholder consultation period, which lasted from May to July 2021. The central themes of the modernization to meet technology advances, new trial types and designs and new types of promising health products include:
- Agile life cycle
- Risk-based approach
- Terms and conditions
- Decentralized trials
- Service provider oversight
Health Canada – Drugs and Natural Health Product Records Retention Change
See the ASK JEAN article for an update on the retention period requirements and the impact for sites.
March and April have been active months for the ICH Expert Working Groups.
E (Efficacy) Family Update
ICH E11A draft Guideline on Pediatric Extrapolation reached Step 2 of the ICH process on and is now in the publica and stakeholder consultation period. This new ICH Guideline aims to promote international harmonisation of methodologies and strategies to incorporate paediatric extrapolation into overall drug development plans and to improve the speed of access to new drugs for paediatric patients, while limiting the number of children required for enrolment in clinical trials. This is an important component of QbD. Congratulations and our gratitude to Drs. Helen Mao and Alex Bliu, the Canadians that served on the expert working group (EWG) to bring this complex document to this stage.
Q (Quality) Family Update
Both Q2 Validation of Analytic Procedures and Q14 Analytic Procedure Development reached Step 2 of the ICH process. They are also now in the public and stakeholder consultation period. Thank you to the EWG members