Health Canada has announced the implementation of guideline S12 on nonclinical biodistribution considerations for gene therapy.
The guideline according to ICH
- Provides harmonized recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products;
- Includes recommendations to facilitate the development of GT products while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles;
- Makes recommendations for the overall design of nonclinical BD assessments.
Need to know more about Therapy Products regulation changes? Get in touch with RegASK’s experts.Contact RegASK for more details Read more