![]() Guidance Document: Preparation of Regulatory Activities in "Non-eCTD Electronic-Only" Format. (Div.1, Div.5, Div.8, DSUR, Post-market Vigilance, Level III, DNF and MF) Guidance Document: Preparation of Drug Regulatory Activities in "Non-eCTD Electronic-Only" Format. Notice: Health Canada's requirements for filing a regulatory activity in "non-eCTD electronic-only" format. This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable Guidance documents. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. Alternate approaches should be discussed in advance with the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.Īs 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 document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a therapeutic product. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective. Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations.
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