Changes to notification requirements for biologic drugs: Notice to industry
Health Canada is reducing the administrative burden to help clinical trial sponsors and market authorization holders efficiently distribute treatments.
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Purpose and background
The COVID-19 pandemic has created an unprecedented demand on Canada’s health system. Health Canada is implementing innovative and flexible measures to help prioritize and expedite the regulatory review of COVID-19 health products without compromising Canada’s high standard of safety. These measures will ensure that needed health products and medical supplies are available to Canadians and healthcare workers.
Measures to expedite the lot release of biologic drugs in groups 1A and 4
Effective immediately, clinical trial sponsors and market authorization holders are no longer required to provide fax-back notifications to the Biologic and Radiopharmaceutical Drugs Directorate prior to the distribution of certain biologic drug lots:
- intended for use in clinical trials holding a No Objection Letter or Notice of Authorization (other than prophylactic vaccines)
- intended for the Canadian market for products holding a Notice of Compliance
This change applies to biologic drugs:
- that do not contain Human Derived Excipients (HDE), such as human serum albumin
- for which specifications have been met
Fax-back notifications are still required for:
- groups 1A and 4 products containing Human Derived Active Ingredients
- groups 1A and 4 products containing HDE
- clinical trial lots for fecal therapies
- clinical trial lots that are out of specification
For prophylactic vaccine lots to be used in clinical trials, a formal request for release, with the relevant lot release documentation, is still required.
We will share updates with sponsors as applicable. If you have any questions, please contact: firstname.lastname@example.org
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