Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile app, that is directly linked to a product’s packaging or label.
Consultation on the draft guidance document is open until May 7, 2021.
Background and scope
The draft guidance would apply to prescription drugs for human use with labels that are linked (e.g., through a barcode or listed web address) to an electronic platform that contains drug information covered by the label. A drug’s “label” can include its inner or outer labels, a package insert, or its product monograph (PM).
The draft guidance is based on Health Canada’s existing legal framework. It does not propose any legislative or regulatory changes. The draft guidance notes that use of electronic media within this framework is voluntary. As such, supplemental electronic information cannot replace that which is required on physical drug labels.
The draft guidance does not apply to electronic platforms that only contain electronic versions of already-approved PMs or package inserts without any other product-specific information. The draft guidance also does not address clinical trial use.
Guidelines for electronic labelling
The draft guidance sets out seven guidelines for manufacturers to follow when incorporating electronic labeling into their existing practices:
- Links and barcodes: Drug sponsors should be mindful of a drug label’s overall legibility when incorporating a link, and do so in a way that maximizes user accessibility (e.g., include both a barcode and a simple URL, as well as short statement of purpose and instructions for use).
- Advertising: The design and content of the electronic platform must comply with federal advertising laws. This may require the use of authentication-based ‘gating’ to prevent members of the general public from accessing parts of the site directed to patients or health care providers.
- Content and sources: Drug information on an electronic platform must be consistent with the most up-to-date version of the drug’s approved Canadian PM. Any non-drug information must be derived from trusted, high-quality sources.
- Separation of information: If the electronic platform contains both label and non-label information, such materials should be clearly separated. For instance, Health Canada-approved information should be placed in a different area, or on a different webpage, of a site.
- Plain-language labelling: Information should be presented in a clear, understandable manner that is mindful of potential accessibility barriers created by electronic platforms (e.g., dynamic elements such as audio and video content).
- Protection of personal information: Any personal information collected through a platform must be protected. The draft guidance notes that this information will be subject to the Personal Information Protection and Electronic Documents Act.
- Maintenance: Drug sponsors must maintain complete control over their digital platforms, including any linked information. Contracting a third party to host a platform does not change a drug sponsor’s regulatory obligations, regardless of the platform’s host or location, and any agreements with third parties.
Submission of Electronic Labelling Materials
Under the draft guidance, electronic labels will be assessed by Health Canada as part of the established regulatory drug review processes.
Drug sponsors are encouraged to indicate the inclusion of electronic labelling materials when requesting a pre-submission meeting before filing any drug submission and to pose specific questions regarding such electronic materials. Mock-ups of electronic labels must be submitted at the time of initial filing, with final labels provided during the review process. Any non-label information need not be submitted.
Health Canada also strongly encourages drug sponsors to submit all electronic materials to an independent advertising agency for preclearance prior to launching an electronic platform.
Link to the draft Guidance: Draft Guidance Document: Electronic media in prescription drug labelling