Question Period Note: AGILE REGULATORY PROCESSES TO SUPPORT ACCESS TO CLINICAL TRIALS FOR VACCINES AND TREATMENTS FOR COVID-19

• Health Canada is using agile regulatory processes to expedite the review of COVID-19 clinical trials for vaccines and treatments.

• Health Canada introduced agile regulatory processes to expedite the review and facilitate the conduct of clinical trials for COVID-19 vaccines and treatments while maintaining its high standards for safety, efficacy and quality.
• Health Canada continues to expedite the review of clinical trial applications and issues a decision in under 15 days, which is half the standard time.
• These measures have allowed us to rapidly authorize several clinical trials in Canada, including for some vaccines being developed in Canada, without compromising on strict standards for the safety of clinical trial participants.

IF PRESSED FURTHER ON CLINICAL TRIALS
• Clinical trials regulations allow the investigation of new drugs or new uses of drugs while affording protection of participants and requiring the proper collection and retention of outcomes.
• Health Canada is expediting the review of clinical trial applications so that products can be studied and made available to Canadians as quickly as possible.
• As of May 18, 2022, 116 clinical trials for COVID drugs and vaccines have been authorized in Canada.

IF PRESSED ON APPROVAL OF VACCINE MANUFACTURING SITES FOR DOMESTIC PRODUCTION
• As the regulator of health products, Health Canada’s role is to authorize products for clinical trials or for sale in Canada, regardless of where they are manufactured.
• For any domestic production of vaccines, Health Canada would inspect and license manufacturing facilities.
• Health Canada inspectors have been working with the National Research Council to provide advice on upgrading their facilities so that they can be licensed to produce vaccines.

Health Canada is expediting the review of all clinical trials applications for treatments and vaccines for COVID-19 while continuing to ensure that clinical trial standards are followed. Clinical trials are conducted to determine whether new vaccines and treatments are both safe and effective in human beings. Health Canada has also been facilitating clinical trials related to COVID-19 in Canada, using the Interim Order (IO) respecting clinical trials for medical devices and drugs (including vaccines) related to COVID-19, which was issued in May 2020 (IO no1) and extended in May 2021 (IO no2).

On February 27, 2022, the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations) came into force, replacing the second interim order (IO No. 2), which was repealed on February 26, 2022.

The Regulations maintain the optional pathway introduced in the IOs as well as all the flexibilities set out by them. They continue to facilitate the authorization and implementation of COVID-19 related clinical trials by reducing administrative burden, all while upholding the health and safety requirements for trial participants and validity of trial data.

The Regulations continue to offer regulatory flexibility to allow for broader types of COVID-19 clinical trials to take place more efficiently. This flexibility also facilitates broader patient and volunteer participation across the country. The Regulations help to:
• reduce administrative requirements for assessing the use of existing marketed products as possible COVID-19-related therapies;
• allow alternate means of obtaining patient consent in light of public health measures;
• broaden the criteria for health professionals who can carry out qualified investigator duties at remote sites; and,
• expand the range of applicants who are able to apply for a medical device clinical trial authorization.

The Regulations include changes to reduce the records retention period for all clinical trials of drugs and natural health products from 25 years to 15 years to improve alignment with international regulatory partners. They also establish a records retention period of 15 years for all COVID clinical trials.

Health Canada reviews clinical trial applications and issues a decision in under 15 days (i.e., half the normal time).

KEY FACTS
• Health Canada is expediting the review of all clinical trials for treatments and vaccines for COVID-19 while continuing to ensure that clinical trial standards are followed.
• Health Canada reviews clinical trial applications and issues a decision in under 15 days (i.e., half the normal time).