The South African Health Products Regulatory Authority (SAHPRA) has released a communication "Implementation of RIMS – Information on eCTD 3.1 Module 1" providing an update on the progress of the Regulatory Information Management System (RIMS) deployment and the implementation of the new eCTD 3.1 Module 1 specifications. This update underscores SAHPRA's commitment to harmonizing its regulatory framework with global best practices and adapting to evolving regulatory contexts both locally and abroad.
Key Points from the Communication
1. Harmonization and Global Best Practices
SAHPRA is dedicated to aligning its regulatory processes with global best practices and the frameworks and specifications from other recognized regulatory authorities.
The new eCTD 3.1 specifications have been developed with an eye toward global harmonization, facilitating a smoother transition to ICH 4.0 over the next five years.
2. Adaptations to Local Regulatory Context
The new specifications take into account significant changes in the local regulatory landscape, including the Co-Applicancy framework and support for local manufacturing.
These adaptations are designed to ensure that the eCTD 3.1 remains relevant and beneficial to the South African context.
3. Inclusion of Section 1.2.4 – Patent Declaration
A new element, Section 1.2.4 under Module 1, has been introduced for the Patent Declaration.
This section is not compulsory; applicants can include the information if available (e.g., for an innovator applying for a new product). If not available, a page indicating “Not Applicable” can be included.
It is crucial to note that the absence of a statement indicating “Not Applicable” in Section 1.2.4 should be marked as a WARNING rather than an ERROR according to the validation tool, as specified in the Validation Criteria document (refer to 2.22 ZA-SAHPRA eCTD Validation Criteria v3.1).
4. Focus on Schema Updates
SAHPRA is focusing on updates to the Schemas rather than making structural changes at the early stages of implementing the new specifications.
This approach is intended to minimize the time required for stakeholders to adapt to the new software tools and specifications.
5. Guidance and Support
SAHPRA encourages stakeholders to use the provided guidance if they are unsure about what to include in Section 1.2.4.
For further clarification, stakeholders are invited to reach out to SAHPRA for support.
SAHPRA's communication highlights the significant strides being made in deploying the RIMS and updating the eCTD specifications to align with international standards while considering local regulatory needs.
This proactive approach aims to enhance the efficiency and effectiveness of the regulatory processes in South Africa, ultimately supporting the goal of harmonization and standardization.
For more detailed information, you can access the full communication here.
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