On 31 July 2021, the minister of health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for Spring 2022 and are intended to modernise the regulatory system for drugs and medical devices, as described below:
- terms and conditions – the amendments will expand the minister's ability to impose terms and conditions on the market authorisation of drugs and medical devices;
- risk management plans – the amendments will create a new requirement for applicants to provide the minister with a risk management plan (and to update it in some circumstances);
- rolling submissions – the amendments will create an optional pathway for the regulatory approval of drugs that permits manufacturers to file data on a rolling basis, beginning with the submission of an initial data package and a plan to provide outstanding data within a set period of time. This pathway, currently available for covid-19 drugs, will be expanded to drugs that address "significant new and emerging infectious diseases in Canada" or "the treatment, prevention or diagnosis of serious or severely debilitating diseases or conditions";
- modernising requirements for biologic drugs – the amendments will repeal and/or replace several outdated requirements for biologic drugs, including relating to:
- biological starting and auxiliary materials;
- contamination or cross-contamination;
- storage and transport;
- outdated individual standards for biologic drugs;
- lot release;
- labelling; and
- on-site evaluation of manufacturing facilities.
For further information on this topic please contact Brandon Heard at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.