Health Canada Quality Guidance

Integrated addendum to e6 r1 health canada ich.

Health canada quality guidance. Health canada guidance for records related to clinical trials. 61 62 this document should be read in conjunction with the accompanying notice and the relevant. Medical device regulations part 3.

2007 health canada draft guidance document. For placebo controlled studies a qualitative list of the ingredients in the. Health canada is committed to.

Health canada recently published the final version of a number of guidance documents and templates which implement new requirements for new drug submissions and abbreviated new drug submissions. 58 guidance in order to allow the department to adequately assess the safety efficacy or quality of 59 a therapeutic product. Sponsors should also refer to the applicable health canada quality guidances and updated notices for additional information.

The information in the protocol must follow the health canada ich guidance document e6. Guidance for clinical trial sponsors. Quality guidance assists sponsors with the classification of quality changes made to a new drug that has received a notice of compliance noc.

The changes will be implemented by way of a phased in approach with the general quality guidance requirements being implemented in january 2018 and the new stability requirements and requirements for. They are intended to assist in preparing drug submissions when seeking an approval to sell a pharmaceutical drug product in canada. Food and drug regulations division 5.

Health canada is committed to ensuring that such requests are justifiable 60 and that decisions are clearly documented. Natural health products part 4. As a corollary to the above it is equally important to note that health canada reserves the right to request information or material or define conditions not specifically described in this guidance in order to allow the department to adequately assess the safety efficacy or quality of a therapeutic product.