FDA published guidance to address the COVID-19 public health emergency – “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing”
Since June 2016, Health Canada has been providing the Validation Reports only for regulatory transactions that failed validation.
Sponsors are expected to validate their eCTD regulatory transactions and correct any warning(s) and error(s) before sending them to Health Canada.
Although the Agency updated validation criteria without further notice, as of March 30,
- On 01 January 2019 the new SWISSmedic update Module 1 Specification for eCTD v1.4 is implemented.
- Both versions (v1.3 and v1.4) will be valid for a half-year period from 01 January 2019 to 30 June 2019.
- As from 01 July 2019 the Swiss Module 1 Specification for eCTD v1.4 must be used for all eCTD submissions.
FDA has updated the guideline for Specifications for eCTD Validation Criteria (V3.8). In this version FDA updated;
- Descriptions of the eCTD Validation Criteria of Error Codes 1734, 1735, and 1736 which support the Study Data Technical Conformance Guide
Again, FDA has updated the Providing Regulatory Submissions in Electronic Format guideline. Now, the requirement to submit DMF Type III (Packaging Material) electronically (in eCTD format only) become effective 60 months after May 5, 2015 (May 5, 2020).
For DMF Type III, applicant must electronically submit any amendments, supplements, and reports,
These Validation rules build on the information provided in Preparation of Regulatory Activities in “Non-eCTD Electronic-Only” format guideline.
The revised rules assist stakeholders in the preparation of regulatory transactions in Non-eCTD format.
It is important for sponsors to ensure that the validation rules are followed accurately in order to avoid encountering validation errors.
Health Canada has updated the timeline for Mandatory Use of eCTD Format for Types of Regulatory Activity.
From since 2004, Health Canada is accepting regulatory activities in eCTD format. As of December 2018, 93 percent of regulatory activities (Part C, Division 8 of the Food and Drug Regulations, for human drugs) have been submitted in eCTD format.
- Singapore HAS (Health Sciences Authority) plans to commence the development phase in 2019 in order to allow eCTD submissions by the end of 2020.
- eCTD will start with new original marketing applications (NDAs and GDAs).
- eCTD submissions will be voluntary during the initial implementation period. The requirement for mandatory submissions will be reviewed at a later date.
FDA has updated the guideline for module 1 specifications version from v2.3 to v2.4.
Summary of Changes for Version 2.4
Added eCTD Submission Type ‘REMS Supplement’. The updated sections are listed below:
- ‘REMS Supplement’ added in Submission Types and Description of Use Table
- ‘REMS Supplement’ added as valid submission type for PAS and CBE-30 in Supplement-Effective-Date-Types and Descriptions of Use Table
- ‘REMS Supplement’ added as valid submission type for submission sub-types of ‘application’,
FDA has updated the guideline for eCTD Technical Conformance Guide (v1.3). In this version FDA;
- Updated/Clarified following sections;
Updation and Clarification
(eCTD Submission Tracking and Life Cycle)