Pre-Market Transparency Initiatives reach Phase III in Canada

Health Canada has reported that its 2017 consultation on five proposals around prescription drug transparency has been successfully concluded, and it has determined which proposals it will take forward.

The Health Products and Food Branch (HPFB) has announced changes to its, still relatively new, Regulatory Decisions Summary (RDS) and Submissions Under Review (SUR). RDS documents give information about the decisions behind approving or rejecting medicines for sale in Canada, and the SUR list shows which products are under review in Canada, allowing patients and healthcare providers a much greater level of transparency in their systems.

The following changes to RDS will be implemented:

“In Phase III, RDSs will be prepared and posted for the following:

  • final positive decisions issued on or after October 1, 2018 for prescription generic drug submissions [Abbreviated New Drug Submissions (ANDSs) and Supplemental Abbreviated New Drug Submissions (SANDSs)] that might be of interest to stakeholders
  • final negative decisions issued for prescription generic drug submissions (ANDSs and SANDSs) that might be of interest to stakeholders and are accepted into review on or after October 1, 2018
  • Supplemental New Drug Submissions (SNDSs) for new routes of administration, dosage forms, and strengths that are issued a final positive decision on or after October 1, 2018″

The SUR list will also change:

  • “A new list of prescription generic drug submissions (ANDSs) under review will be published, and will include ANDSs accepted into review on or after October 1, 2018. The list will include medicinal ingredient(s), therapeutic area, and number of applicable submissions.
  • The sponsor (company) name will be added to the existing “List of Submissions Currently Under Review” for eligible New Drug Submissions (NDSs) and SNDSs accepted into review on or after October 1, 2018.
  • The submission ‘class’ will be added to the “List of Submissions Currently Under Review” for eligible NDSs and SNDSs accepted into review on or after October 1, 2018″

For more detail on the Health Canada announcement, please read their original article here.

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Published 30. August 2018 in News, News Canada