Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs

February 17, 2017
Reference number: 17-101626-819

Health Canada is pleased to announce the release of the Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs for external consultation.

The draft guidance document clarifies the requirements for eligible drug submissions and applications under the administrative pathway. These submissions and applications do not contain scientific data, or require regulatory review.

The 1998 Change in Manufacturer’s / Product Name Policy (CMPN), which was updated in 2001, governs the administrative processing of drug submissions and applications. Since the implementation of the CMPN policy, the number of drug submissions and applications filed under the administrative pathway has increased significantly. The draft guidance document addresses certain policy gaps have been identified throughout the years, and provides further clarity to industry on the requirements under this administrative pathway. Once finalized, the draft guidance document would replace the CMPN Policy.

Certain clarifications in the new draft guidance document pertain to:

• types of changes that are eligible under the administrative pathway;
• roles and responsibilities of manufacturers, including those of licensors and licensees;
• general document requirements and additional document requirements for different business arrangements;
• drug identification number (DIN) issuance and cancellations; and,
• labelling considerations.

Stakeholders are encouraged to provide feedback on implementation, and provide suggestions on timelines for the coming into effect of the guidance document.

Questions or comments related to this guidance document should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott St.
Ottawa, Ontario
K1A 0K9

Telephone: 613-957-1058
Email: Policy_Bureau_Enquiries@hc-sc.gc.ca

Fax number: 613-914-1812