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:
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 the assessment goal dates for applications. This replaces the July 2018 guidance for ANDA Amendments under GDUFA.
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.
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.
- 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.
- Note, due to minor errors in the eCTD M1 Specification and the corresponding eCTD Validation Criteria SWISSmedic updated both the guidelines but the version number 1.4 will be retained.