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Draft guidance document on the collection and analysis of disaggregated data in clinical trials: Transparency

Health Canada will continue to communicate up-to-date information about drugs for human use. You can find the following information online:

  • Notice of Compliance (NOC) database: contains NOCs issued for drugs for human and veterinary use
  • Drug product database: contains information about drug identification numbers (DINs) issued for drugs for human and veterinary use, including the product monograph for human drugs and the product labelling for veterinary drugs
  • Drug and Health Product Portal: contains Regulatory Decision Summaries and Summary Basis of Decision documents, which describe Health Canada's rationale for the approval of prescription drugs for human use
  • Clinical information portal: contains the clinical information, including disaggregated data, filed by sponsors to seek approval of human drugs under Division 8 of the Food and Drug Regulations (FDR)

Information posted will not contain any confidential business information.

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2022-12-16

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