Canada Aims To Implement eCTD v4 By 2022
Executive Summary
Canada joins other international regulators in announcing plans to implement the next major revision of the electronic common technical document format (eCTD v4). A roadmap has been issued to help pharmaceutical companies prepare and plan for this change.
Health Canada has announced plans to adopt the international standard for the submission of regulated products – i.e., the Health Level 7 (HL7) Regulated Product Submission (RPS) standard – starting with the implementation of the next major revision of the electronic common technical document (eCTD v4) by 2022.
Replacing the current eCTD 3.2.2 version with the new eCTD v4 format will require advanced notice, planning and collaboration. Health Canada intends to develop supporting rules and guidance documents in consultation with stakeholders over the next two years. This will be followed by system development, pilot testing and the undertaking of supporting operations over the next four years. The Canadian regulator expects to begin receiving live transition mapping messages and v4 messages by 2022.
The next milestone in the process will be the publication of the draft implementation package (technical guidance) for stakeholder consultation later this year.
While the RPS standard can support all regulated products, including human and veterinary medicines and medical devices, the current focus is on applying it to eCTD v4, which deals with human drugs. One of the major benefits of the RPS standard is that it would enable two-way communication between drug sponsors and Health Canada via the Common Electronic Gateway (CESG).
Also, RPS supports advanced lifecycle management. This has several advantages. For example, it enables one regulatory activity to be related to multiple dossiers, allows one file to replace multiple existing files, enables a document to be submitted once and reused across regulatory activities, and makes it possible to modify metadata. “The adoption of the RPS standard is part of Health Canada’s effort to move towards a common submission intake process,” the regulator said.
The eCTD v4 was developed by the International Council for Harmonisation in collaboration with standards organization HL7, and all the ICH regulatory members have committed to adopting the format in their respective regulatory frameworks. Both the EU and the US have also issued their implementation plans for eCTD v4. (Also see "US FDA drafts 5-yr plan to strengthen e-submission of drug applications, data" - Pink Sheet, 3 Jan, 2014.)
From the editors of Scrip Regulatory Affairs.