Health Canada has made a policy change that will allow for new drugs that contain restricted substances to be brought to market. The amendment, which was announced on January 5th 2022, reverses a 2013 policy that prevented “a letter of authorization for a new drug that is or that contains a restricted drug.” This change is being made in an effort to improve patient access to innovative therapies.
Health Canada officials say that the amendment is in response to requests from industry and other stakeholders. This amendment provides clarity on how new drugs containing restricted substances can be brought to market, while ensuring that public health and safety are maintained.
The change will allow for the development of new therapies that contain restricted substances, such as psychedelics’. This will provide patients with access to innovative treatments that could improve their quality of life. Health Canada is committed to ensuring that patients have access to the best possible care, and this amendment is an important first step towards achieving that goal.
Physicians will be able to request patient access to illegal psychoactive substances including MDMA and psilocybin for psychedelic-assisted therapy under Health Canada’s Special Access Program (SAP). Decisions will be made on a case-by-case basis, with priority given to significant treatment-resistant or life-threatening illnesses for which other medicines have failed, are ineffective, or are unavailable in Canada.
This amendment is good news for patients and the pharmaceutical industry. It will allow for the development of new therapies that could improve the quality of life for many people.
Written by Med Plant Science