CA Kanada
  • 11 - Medizintechnik

Drugs and medical devices (ICS codes: 11.120, 11.040)

Regulations Amending Certain Regulations made under the Food and Drugs Act (Agile Licensing); (93 page(s), in English), (93 page(s), in French)

Health Canada is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations that would deliver on the Department's modernization commitments and leverage long-standing policies and practices. The proposal would take into account recent experience with regulatory agilities successfully piloted through the COVID-19 interim orders and their transition to regulations. This proposal is comprised of distinct components that would:

·         Enable the use of terms and conditions on the drug identification number of any drug;

·         Broaden the scope of use of terms and conditions for Class II, III, and IV medical devices;

·         Require risk management plans for certain human drugs to manage risks and uncertainties;

·         Allow for the option of a rolling review for certain drug submissions, including those for drugs intended to address a public health emergency;

·         Extend modified requirements and prepositioning that apply to COVID-19 drugs to other drugs needed to address future public health emergencies;

·         Clarify expectations that a drug be fabricated, packaged/labelled, tested and stored, including during transportation, in a manner that assures its quality;

·         Modernize requirements for biologics by repealing outdated requirements and replacing them with those that reflect current practices;

·         Clarify, in regulation, the authority to consider certain information obtained outside of a new drug submission to support Health Canada's examination of that submission for a new drug;

·         Require manufacturers to submit human clinical trial data broken down by population sub-groups (disaggregated data) for new and supplemental human drug submissions, as submitted to the United States Food and Drug Administration or the European Medicines Agency; and

·        Update requirements respecting standards for labelling and requirements for those that claim a manufacturer's standard for their drug.