The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for "ECTD Validation And Technical Screening For Renewals" specifically aimed at renewals. This guidance is crucial for pharmaceutical companies seeking to maintain the registration of their medicinal products while adhering to the latest technical and regulatory standards.
electronic Common Technical Document (eCTD) is a standard developed by the International Council for Harmonisation (ICH) to streamline the submission process for regulatory applications across various health authorities.
It is a structured, electronic format that organizes product information in a standardized manner, allowing both pharmaceutical companies and regulatory bodies to access and review critical documentation easily.
The eCTD validation and technical screening process ensures that electronic submissions comply with both the technical standards of eCTD and the specific requirements set by SAHPRA. This two-stage process minimizes the risk of delays caused by incomplete or incorrectly formatted submissions.
eCTD Validation
Validation refers to the process of ensuring that the eCTD submission is technically sound, with proper structure, formatting, and metadata. The main objectives of validation include:
File Format Compliance: The submission must comply with eCTD specifications regarding file formats (such as PDF, XML), naming conventions, and directory structures.
Metadata Accuracy: Information regarding the product, version, and applicant must be accurate and properly linked throughout the submission.
File Organization: All documents need to be placed in the correct modules and sections.
Technical Screening
Once validation is complete, technical screening involves a review of the content to confirm that all necessary documents are included and meet SAHPRA’s regulatory requirements. Key considerations during this phase include:
Completeness of Documents: Ensuring all required documents, such as clinical study reports, quality information, and administrative forms, are present.
Correct Placement: Verifying that each document is placed in the appropriate section of the eCTD, following the required structure.
To aid pharmaceutical companies in submitting renewals, SAHPRA provides a Renewals Validation Template for eCTD. This template acts as a checklist to ensure that all necessary elements are included in the renewal application. The template covers critical areas such as:
Document formatting and placement
File naming conventions
Submission metadata (e.g., product information, application type)
Technical validations (file types, folder structures, and cross-references)
The Renewals Validation Template helps applicants avoid common pitfalls and ensures that submissions meet SAHPRA’s technical and regulatory standards.
References
SAHPRA Guidance Document: eCTD Validation and Technical Screening for Renewals
SAHPRA Renewals Validation Template: GLF-HPA-04A v4 Renewals Validation Template for eCTD
By staying compliant with these updated guidelines, pharmaceutical companies can streamline their regulatory submissions, ensuring that patients continue to have access to essential medications without unnecessary delays.
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