In month of June 2020, USFDA updated header of Structured Product Labeling (SPL) XML:
Error during the Pragmatic SPL Data Validation with old header:
World-wide Health Authorities continuously updating requirements and standards for electronic submission, so it much necessary to keep updated your self with current specifications to make eCTD submission 100% error free and compliant.
Current eCTD Module 1 Specification, DTD, and Validation Criteria Version with Update
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M1 Spec
DTD
Validation Criteria
Current Update
1.
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,
FDA has updated the guideline for Specifications for eCTD Validation Criteria (V3.8). In this version FDA updated;
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.