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This guidance document addresses the development of contraceptive products, intended for use by women during their reproductive years, which contain sex steroids as active ingredient(s).

These guidelines have been developed by a Therapeutic Products Programme's Working Group for the Toxicological Assessment of Contraceptive Steroids in close consultation with several experts in the fields of toxicology, pathology and reproductive physiology.

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

This guidance is intended to harmonize and to update the prescribing information for nonsteroidal anti-inflammatory drugs () indicated for controlling pain and inflammation associated with rheumatic diseases and other less severe conditions.

Canada's regulatory approach: Drugs for rare diseases are authorized for sale in Canada under the Food and Drugs Act and Part C of the Food and Drug Regulations.

Health Canada’s Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) are responsible for reviewing the applications for authorization to sell or import drugs for the purposes of conducting clinical trials in Canada.

Health Canada has authorized certain clinical trials in patients in Canada. Our public Clinical Trials Database is a public listing of specific information relating to these trials. Additional publicly accessible registries that further support finding suitable trials are: ClinicalTrials.gov and Current Controlled Trials International Standard Randomized Controlled Trials Number Register.

Anyone can find out if a submission has been accepted for review by Health Canada by searching the submissions under review list. We publish Regulatory Decision Summaries (RDS). These summaries explain the purpose of the submission and the reason(s) for Health Canada’s decision on certain health products seeking market authorization. You can access RDSs through the Drug and Health Product Register.

Canada’s health care system is complex and involves the participation of multiple stakeholders, who all have distinct roles in the planning and delivery of healthcare services. Health Canada’s decision-making role in approving a drug for marketing is distinct from the roles of those who make decisions about price-setting and public drug plan reimbursements.

Special access programs.