AEGiS-06IAC: Canada's drug regulatory response to AIDS: progress in 1989-90

6th International AIDS Conference

San Francisco, California, USA — June 20-23, 1990

Canada's drug regulatory response to AIDS: progress in 1989-90

Int Conf AIDS 1990 Jun 20-23; 6:305 (abstract no. S.D.862)
Brill-Edwards M, Khan S, Turner C, Somers E; Drugs Directorate, Health Protection Branch, Health & Welfare Canada, Ottawa, Ontario, Canada

OBJECTIVE: The AIDS epidemic has focused attention on new drug development of anti-virals, anti-parasitics and anti-infectives for a variety of previously rare organisms. To ensure that the Canadian regulatory procedures facilitate timely new drug development, the Drugs Directorate of the Health Protection Branch, Health and Welfare Canada, has recently implemented several important changes in policy and procedures.

METHODS: These include: 1. The information of a new unit for the evaluation and regulation of anti-virals and AIDS related prescription medicines, 2. Implementation of an innovative system for fast tracking AIDS related therapies (a first for the Canadian Drug Regulatory System), 3. Increased communication with industry and health professionals, and 4. A public communications strategy for "breaking" news.

RESULTS: These innovative efforts have resulted in: 1. Canada's first drug marketing approvals for AIDS related therapies, 2. increased timely access to investigational agents, and 3. a record number of approvals for investigational protocols for HIV related drugs in 1989-90.

CONCLUSIONS: The operational mandate of the HPB respecting AIDS related therapies is adapting to facilitate timely drug development while recognizing the need for early access to investigational therapies.

Keywords: AEGIS, Acquired Immunodeficiency Syndrome, Sjogren's Syndrome, Drug Approval, Pharmaceutical Preparations, Canada, HIV Infections, Public Policy, Drugs, Investigational, Medicine, Social Welfare, North America, legislation & jurisprudence, methods, ICA6

900620
SD862