Notice: Phase III of Pre-Market Transparency Initiatives for Prescription Drugs

August 21, 2018

Our file number: 18-109-632-884

Phase III of Pre-Market Transparency Initiatives for Prescription Drugs

As a regulator, Health Canada plays an important role in protecting the health and safety of Canadians. Health Canada is committed to being transparent and open about its activities and to making timely and useful information available about health products and health product submissions. Greater transparency and openness with Canadians strengthens the trust in our regulatory decisions, and ultimately supports Canadians in making better decisions about their health.

To support the Department's commitment, the Health Products and Food Branch (HPFB) continues to develop its pre-market transparency initiatives related to prescription drugs (pharmaceuticals and biologics). These include Regulatory Decision Summaries, and the Submissions Under Review List.

A Regulatory Decision Summary (RDS) explains Health Canada's decision to approve or reject the sale of certain prescription pharmaceutical and biologic drug and medical device products in Canada. A summary is also published when certain submissions are cancelled or withdrawn by the company (sponsor) before a decision is made. The RDSs include the reason a submission was made (for example to treat a certain illness in a particular group of people), a summary of the data submitted, and the reason for Health Canada's decision. RDSs are posted for new drug submissions for prescription pharmaceuticals and biologics and for supplements for new uses, as well as for new Class IV medical device licence applications.

The Submissions Under Review (SUR) Listinforms Canadians as to whether a drug product has been accepted for review in Canada, which may help to support them in making better decisions about their health. It provides a list, updated monthly, of certain drug submissions currently under review by Health Canada. The SUR List includes all new drug submissions for prescription pharmaceuticals and biologics and supplements for new uses that have been accepted for review.

The RDS and SUR List initiatives were launched in 2015 as part of HPFB's ongoing commitment to enhance the transparency of the pharmaceutical, biologic and medical device regulatory review processes. Phase I was launched in 2015 and Phase II in 2016. In the fall of 2017, HPFB consulted on five proposals related to prescription drug product transparency initiatives. A "What we heard" report was published in April 2018.

As of October 1, 2018 HPFB will move forward with these five proposals and launch Phase III of the RDS and SUR List initiatives.

More specifically, 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

In addition, the SUR List initiative will change as follows:

  • 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.

More detailed information regarding the implementation of Phase III is described below.

Implementation of Phase III of Pre-Market Transparency Initiatives for Prescription Drugs

The following sections describe each of the five proposals that were part of the consultation in the fall of 2017, and details regarding implementation.

Proposal 1: Publishing a summary document that would explain Health Canada's decision for certain prescription generic drug submissions

HPFB will begin to publish RDSs for final positive and negative decisions on ANDSs and SANDSs for prescription pharmaceuticals and biologics that HPFB decides might be of interest to stakeholders. Possible examples of eligible submissions/decisions could include the following:

  • Where HPFB significantly deviates from its published guidance documents
  • Critical dose drugs
  • Complex drug substances and/or drug products

HPFB reviewers will identify potentially eligible submissions during review; management approval on eligibility will be sought and then sponsors will be notified individually. The RDSs will be structured like the current RDSs for NDSs and SNDSs, with the addition of the Canadian Reference Product. The RDS will be posted after the final decision has been issued. Therefore, if the eligible ANDS or SANDS is placed on Intellectual Property (IP) Hold, the RDS will not be posted until the Notice of Compliance is issued. The RDSs for (S)ANDSs will be posted with the other RDSs in the Drug and Health Product Register (DHPR).

Decisions in scope are as follows:

  • final positive decisions issued on or after October 1, 2018 for ANDSs and SANDSs that might be of interest to stakeholders
  • final negative decisions for ANDSs and SANDSs that might be of interest to stakeholders and were accepted into review on or after October 1, 2018

The process for RDS generation and publication for (S)ANDSs will be similar to that currently followed for (S)NDSs. RDSs for final negative decisions will continue to be sent to the sponsor for comment prior to publication.

Proposal 2: Publishing a list of submissions for prescription generic drugs that have been submitted to Health Canada for review

HPFB will begin to publish a SUR List for ANDSs. The list will include medicinal ingredient(s), therapeutic area, and number of submissions. It will be posted separately from the current SUR Lists for NDSs and SNDSs.

Submissions in scope are ANDSs (other than those that are classified as 'administrative' or 'labelling only') that are accepted into review on or after October 1, 2018.

The process for SUR List publication will be similar to that currently followed for the existing SUR Lists. Updates will be posted monthly and will reflect submissions accepted into review the previous month. HPFB's practice to not disclose information other than what is found on the SUR Lists will remain in place.

Proposal 3: Expanding the scope of the current RDS initiative to include approved submissions for new routes of administration, dosage forms, and strengths

HPFB will begin to publish RDSs for final positive decisions on SNDSs for new routes of administration, dosage forms, and strengths for prescription pharmaceuticals and biologics.

The RDSs will be structured like the current RDSs, and will be posted with the other RDSs in the DHPR.

Decisions in scope are final positive decisions issued on or after October 1, 2018 for SNDSs for new routes of administration, dosage forms, and strengths.

The process for RDS generation and publication for these approved SNDSs will be similar to that currently followed for approved (S)NDSs.

Proposal 4: Adding company (sponsor) names to entries on the SUR List

HPFB will begin to add the company name to the "List of submissions currently under review" for eligible NDSs and SNDSs accepted into review on or after October 1, 2018.

This addition will not change the process for SUR List publication. The information will be taken from the internal Drug Submission Tracking System (DSTS). Updates will be posted monthly and will reflect any changes to the company name in DSTS the previous month.

Explanatory text will be added to the SUR List webpage to explain that the company name is only included for submissions accepted into review after the date of implementation.

Proposal 5: Adding submission 'class' to entries on the SUR List

HPFB will begin to add the following submission 'classes' to the "List of submissions currently under review" for eligible NDSs and SNDSs accepted into review on or after October 1, 2018:

  • extraordinary use submission
  • new active substance
  • biosimilar
  • being reviewed under the Priority Review Policy
  • being reviewed under the Notice of Compliance with Conditions Guidance
  • being reviewed under the Submissions Relying on Third-Party Data Guidance
  • part of 'aligned review' with a health technology assessment (HTA) agency

This addition will not change the process for SUR List publication. The information will be taken from DSTS. Updates will be posted monthly and will reflect any changes to this information in DSTS the previous month.

Explanatory text will be added to the SUR List webpage to explain the categories and hyperlink to already-published information such as relevant guidance documents. Text will also be added to explain that the submission 'class' is only included for submissions accepted into review after the date of implementation.

Comments or questions should be directed to the Office of Planning, Performance and Review Services.

  • Office of Planning, Performance and Review Services
    Therapeutic Products Directorate
    Health Canada
    1600 Scott Street, 6th floor
    Ottawa, ON K1A 0K9
  • Telephone: 613-941-1248
  • Facsimile: 613-957-1483
  • Email: hc.opprs.enquiries-enquettes.bprse.sc@canada.ca
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