The FDA oversees both finished dietary supplement products and dietary components. The FDA regulates dietary supplements differently than it does “conventional” foods and drugs. According to the Dietary Supplement Health and Education Act of 1994 (DSHEA):
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Control of Nitrosamine Impurities in Human Drugs Guidance for Industry
Nitrosamine impurities guidance updated with more information related to root causes of formation, mitigation and implementation of recommended AI limits and setting of specification for the recommended acceptable intake in drug products. Guidance has updated from February 2021 Revision 1 to September 2024 Revision 2 complete details provided below:
FDA revised guidance for industry titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.”
This updated guidance outlines how the assessment goals established by the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments made to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) submitted to the FDA. It also provides detailed information on the classification of amendments and how these classifications can impact… Continue reading FDA revised guidance for industry titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.”
SAHPRA eCTD Submission Updates
SAHPRA eCTD Submission Updates SAHPRA eCTD Portal Launch: Beginning October 1, 2024, SAHPRA mandates all applications to be submitted via its eCTD Portal. Through this portal, applicants can register, upload content, and manage submission sequences. Detailed instructions are provided in the SAHPRA eCTD Portal Process Guide.
Health Canada Updated Specifications for eCTD Validation Criteria V4.4
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.
SWISSmedic updated M1 Specification (v1.4) and eCTD Validation Criteria (v1.4)
On 01 January 2019 the new Swiss 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.… Continue reading SWISSmedic updated M1 Specification (v1.4) and eCTD Validation Criteria (v1.4)
US FDA Updated Specifications for eCTD Validation Criteria V3.8
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
Health Canada Updated Validation rules for non-eCTD electronic-only format (V4.4)
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.
US FDA Extended eCTD Deadline for Type III DMFs (Packaging Material)
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).
Health Canada updated notice for Mandatory use of eCTD Format
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… Continue reading Health Canada updated notice for Mandatory use of eCTD Format