By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy.
As part of the Regulatory Transparency and Openness Framework (http://www.hc-sc.gc.ca/home-accueil/rto-tor/index-eng.php), Health Canada has committed to provide greater transparency and openness to further strengthen trust in their regulatory decisions. The Framework will:
- Help Canadians to better understand how and why decisions are made. Canadians will be able to use this information to make well-informed decisions on their health and the health of their families.
- Assist industry to be better positioned to comply with current regulatory requirements and plan for upcoming regulatory changes.
Since 2012, Summary Basis of Decision (SBD) documents are published for ‘novel’ drugs and devices: New Drug Submissions for New Active Substances and a subset of Class IV medical device applications. The SBD documents explain why Health Canada authorized certain drugs for sale in Canada. The documents include regulatory, safety, effectiveness and quality (chemistry and manufacturing) considerations. Under the transparency initiatives, the Health Products and Food Branch (HPFB) proceeded since May 2016 with Phase II of the Regulatory Decision Summary (RDS) and Submissions Under Review (SUR) List initiatives.
Submissions Under Review (SUR)
Canadians can access the list of certain drug submissions currently under review. These submissions include new drug submissions (NDSs) containing new active substances, pharmaceuticals and biologics with an active ingredient not approved in Canada. This applies to submissions whose review started on or after 01 April 1 2015. The following are now included on the SUR List as part of Phase II of the Transparency Initiatives: – Medicinal ingredient and therapeutic class for all NDSs and SNDSs for new indications for pharmaceuticals and biologics accepted into review on or after 01 May 2016 The entry for each submission includes its medicinal ingredient(s) and therapeutic area but not the manufacturer. The list is updated monthly. A substance is removed from these lists:
- once a final decision is made and the submission is no longer under review
- if the submission is cancelled
Canadians can see if a submission has been approved in the Notice of Compliance Database. In addition, an explanation of the decision (positive or negative) or cancellation in the Regulatory Decision Summary (RDS) will be available. If applicable, a more detailed explanation is also contained in a Summary Basis of Decision document.
Regulatory Decision Summary (RDS)
The regulatory decision summaries (RDSs) provide Canadians with an understanding of the decisions to approve or not approve the sale of drugs and medical devices in Canada. RDSs for positive decisions issued after 01 April 2015, are provided for:
- new drug submissions (NDSs) for prescription pharmaceuticals and biologics
- supplemental new drug submissions (SNDSs) for new uses of prescription pharmaceuticals and biologics
- new class IV licence applications for medical devices
Summaries are also posted for negative decisions and cancellations for NDSs accepted into review after 01 April 2015. These submissions are for drugs containing new active substances, pharmaceuticals and biologics with an active ingredient not approved in Canada. The following RDSs for negative decisions and cancellations are now published as part of Phase II of the Transparency Initiatives for submissions accepted into review after 01 May 2016:
- NDSs
- SNDSs for new uses
- new class IV licence applications for medical devices
The following information may be listed on the RDS:
- What was the purpose of this submission?
- Why was the decision issued?
- What did the company submit to support its submission?
- Decision issued
- What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
- Date of decision or cancellation
- What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
- Manufacturer
- Drug Identification Number(s) if issued
- Prescription status
- Type of submission
- Date filed
- Control number
Links Summary Under Review: http://www.healthycanadians.gc.ca/drugs-products-medicaments-produits/authorizing-manufacturing-autorisation-fabrication/review-approvals-evaluation-approbations/submissions-under-review-presentations-cours-examen-eng.php Regulatory Decision Summaries (RDSs), Medical Devices and Drugs: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/index-eng.php Summary Basis of Decision (SBD), Medical Devices and Drugs: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/index-eng.php