SAHPRA South Africa: eCTD Compliance and Technical Review for Renewal Applications – Template

SAHPRA South Africa The South African Health Products Regulatory Authority (SAHPRA) has issued new instructions for “eCTD Validation and Technical Screening for Renewals,” tailored specifically for renewal processes. This updated guidance is essential for pharmaceutical companies aiming to keep their medicinal product registrations current while complying with the most recent technical and regulatory requirements.

The electronic Common Technical Document (eCTD) is a standard established by the International Council for Harmonisation (ICH) to simplify the regulatory submission process across different health authorities. This structured, electronic format organizes product information in a consistent way, facilitating easy access and review of essential documentation by both pharmaceutical companies and regulatory agencies.

The South African Health Products Regulatory Authority (SAHPRA) oversees the eCTD (electronic Common Technical Document) compliance and technical review process for renewal applications. This process ensures that pharmaceutical companies meet both technical and regulatory standards when submitting renewal applications for their medicinal products.

eCTD South Africa SAHPRA: The electronic Common Technical Document (eCTD)

Compliance involves adhering to a standardized electronic format that organizes and presents product information in a consistent manner. This format facilitates efficient review by regulatory bodies and helps prevent issues related to formatting and document placement.

Technical Review focuses on verifying the quality and completeness of the submission. This includes checking that all necessary documents are included, properly formatted, and correctly positioned within the eCTD structure. Additionally, it ensures that metadata such as product details and application type is accurate and appropriately linked.

The review process aims to minimize delays by addressing potential issues early, ensuring that renewal applications are complete and compliant with SAHPRA’s requirements. By following these procedures, pharmaceutical companies can maintain their product registrations smoothly, avoiding interruptions in the availability of medications.

The eCTD validation and technical screening process guarantees that electronic submissions adhere to both the eCTD technical standards and SAHPRA’s specific requirements. This two-step process helps reduce the risk of delays due to incomplete or improperly formatted submissions.

eCTD Validation:South Africa SAHPRA

Validation involves verifying that the eCTD submission meets technical standards, including correct structure, formatting, and metadata. The key goals of validation are:

• File Format Compliance: Ensuring that the submission follows eCTD specifications for file formats (such as PDF and XML), naming conventions, and directory structures.
• Metadata Accuracy: Confirming that details about the product, version, and applicant are accurate and correctly linked throughout the submission.
• File Organization: Making sure all documents are placed in the appropriate modules and sections.

Technical Screening

After validation, technical screening involves reviewing the content to ensure that all required documents are included and comply with SAHPRA’s regulatory standards. Key aspects of this phase include:

• Document Completeness: Confirming that all necessary documents, such as clinical study reports, quality data, and administrative forms, are included.
• Proper Placement: Ensuring each document is correctly positioned in the appropriate section of the eCTD, adhering to the required structure.

To assist pharmaceutical companies with renewal submissions, SAHPRA offers a Renewals Validation Template for eCTD. This template serves as a checklist to ensure that all required components are present in the renewal application. It addresses key areas including:

• Document Formatting and Placement: Guidelines for how documents should be formatted and organized.
• File Naming Conventions: Standards for naming files consistently.
• Submission Metadata: Requirements for metadata such as product details and application type.
• Technical Validations: Checks for file types, folder structures, and cross-references.

The Renewals Validation Template helps applicants avoid common errors and ensures that their submissions comply with SAHPRA’s technical and regulatory requirements.

Importance for SAHPRA

For SAHPRA, the adoption of eCTD enhances the regulatory process by:

1. Improving Efficiency: The eCTD format facilitates faster processing and review of submissions through its structured and indexed approach, which reduces the time required to access and review documents.
2. Ensuring Compliance: It helps in maintaining regulatory compliance by providing a clear and standardized method for submitting documentation, which aligns with international practices.
3. Enhancing Transparency: With eCTD, SAHPRA can track submission progress and updates more effectively, promoting greater transparency and accountability in the regulatory process.
4. Facilitating Communication: The electronic system simplifies communication between pharmaceutical companies and SAHPRA, allowing for more efficient handling of queries and updates.

Submission Process

To submit documents in eCTD format to SAHPRA, applicants must follow these steps:

1. Preparation: Ensure that all documents are prepared in accordance with eCTD specifications, including proper formatting and organization.
2. Submission: Use the appropriate submission system provided by SAHPRA to upload eCTD files.
3. Validation: SAHPRA conducts a validation process to ensure that the eCTD submission complies with the required standards.
4. Review: Once validated, the submission enters the review phase, during which SAHPRA assesses the content in detail.

References

• SAHPRA Guidance Document: eCTD Validation and Technical Screening for Renewals
• SAHPRA Renewals Validation Template: GLF-HPA-04A v4 Renewals Validation Template for eCTD

Adhering to these updated guidelines allows pharmaceutical companies to streamline their regulatory submissions, ensuring that patients have continued access to essential medications without unnecessary delays.