Notice - Implementation of Regulated Product Submission (RPS) and Electronic Common Technical Document version 4 (eCTD v4)

June 16, 2017
Our file number: 17-106410-239

Health Canada is pleased to provide an advanced notice for the intent to adopt the Health Level 7 (HL7) Regulated Product Submission (RPS) standard, and to announce that Health Canada’s first application of the RPS standard will be eCTD v4.

As the next major version of the eCTD format, version 4 replaces the current version of eCTD which is version 3.2.2. The intended scope for eCTD v4 is human drugs and regulatory activities for Part C, Division 5 and Division 8 of the Food and Drug Regulations. The Guidance Document Preparation of Drug Regulatory Activities in eCTD Format will be revised to reflect the scope of eCTD v4.

Health Canada acknowledges that the upgrade to eCTD v4 requires advanced notice, planning and collaboration. To kick-off stakeholder engagement, planning and discussion, this notice is being issued along with a roadmap for consideration (Refer to Table 1).

As the project to implement eCTD v4 progresses, Health Canada will remain engaged with stakeholders via the Health Canada website, the Group on Electronic Regulatory Activities (GERA) and public forums such as the Canadian Association of Professionals in Regulatory Affairs (CAPRA) and Drug Information Association (DIA).

The following are some of the more notable benefits of RPS and eCTD v4:

  • Broad Application: The RPS standard supports all regulated products; for example, human drugs, veterinary drugs and medical devices.
  • International Standard: RPS will be adopted by international regulators.
  • Two-Way Communication: RPS facilitates Sponsor to Health Canada and Health Canada to Sponsor communication via the Common Electronic Gateway (CESG).
  • Advanced Lifecycle Management: RPS supports advanced lifecycle management. For example: one regulatory activity can be related to multiple dossiers; one file can replace multiple existing files; a document can be submitted once and reused across regulatory activities; and the ability to modify metadata.

The adoption of the RPS standard is part of Health Canada’s effort to move towards a common submission intake process. It reinforces our commitment to adopt international data standards, and maintains alignment with other regulatory authorities.

Next Steps

The next milestone will be the publication of the Draft Health Canada Implementation Package (Technical guidance) for comment (Refer to Table 1).

Questions regarding this notice should be sent to ereview@hc-sc.gc.ca.

Background on RPS and eCTD v4

ICH made the decision to develop the next major version of eCTD (i.e., eCTD v4) in collaboration with a Standards Development Organisations like HL7 to leverage a larger pool of technical expertise and for the opportunity to extend the benefits of harmonisation beyond the ICH regions.

The most desirable long-term objective is to have one globally used electronic message standard to exchange information on regulated products based on internationally approved and interoperable standards.Footnote 1

As a messaging standard, RPS is designed to support information exchange for any regulated product between regulators and sponsors, and between regulators. RPS is currently managed under HL7 as a normative standard.

References

The International Council on Harmonisation (ICH) eCTD v4 Implementation Package

Table 1: eCTD v4 Roadmap for comment
Milestones Calendar Year
Health Canada Documents
  • Publish eCTD v4 Notice of Intent
  • Publish Draft Implementation Package (Technical guidance) for comment
2017
  • Publish Draft Implementation package (Business guidance) for comment
  • Publish Draft Validation Rules
  • Publish Draft Transition Mapping Message (TMM) guidance for comment
  • Non-Functional Pilot (Transition Mapping)
  • Revise existing eCTD Question and Answer Document (ongoing)
2018
System Development,
Pilot Testing and Operations
  • Software installation in HC environments
  • Finalize Validation Rules
  • Non-Functional Pilot (Incoming: Activities and Transactions)
  • Non-Functional Pilot (Outgoing: HC Messages; two-way communication)
2019
  • Functional Pilot (Incoming: new and existing dossiers)
  • Functional Pilot (Outgoing: HC Messages; two-way communication)
  • Begin receiving live TMM's and v4 messages
2020 to 2022
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