Sperm and ova for assisted human reproduction
(1) Proposed regulations entitled Safety of Sperm and Ova Regulations (47 pages, available in English and French) (2) Proposed Technical Directive entitled Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors (14 pages, available in English and French) Note: The proposed Technical Directive is incorporated by reference into the proposed Safety of Sperm and Ova Regulations.
The proposed Safety of Sperm and Ova Regulations would establish a human health and safety framework for donor sperm and ova for assisted human reproduction. Specifically, the proposed regulations would:
· Establish minimum requirements for screening and testing sperm and ova donors;
· Establish a risk-based registration and notification oversight scheme for establishments who process, import and distribute donor sperm and ova;
· Establish a traceability system whereby donor sperm and ova are identified, labelled and stored so that appropriate steps may be taken in the event of an error, accident or adverse reaction; and Establish a quality management system to ensure that establishments who conduct their activities do so in a manner that prevents contamination or cross-contamination, prevents the transmission of an infectious disease and maintains the quality of the sperm and ova.