Reopening of the Call for Applications for the Pilot Phase of the Joint Evaluation Project Between the Egyptian Drug Authority (EDA) and the South African Health Products Regulatory Authority (SAHPRA)
Reopening of the Call for Applications for the Pilot Phase of the Joint Evaluation Project Between the Egyptian Drug Authority (EDA) and the South African Health Products Regulatory Authority (SAHPRA)
The Egyptian Drug Authority (EDA) and the South African Health Products Regulatory Authority (SAHPRA) have announced the reopening of their joint pilot project for the collaborative evaluation of biological products, starting from 1 June 2025. This initiative, established under a memorandum of understanding between the two regulatory bodies, aims to streamline the registration process for biological products through a shared assessment framework.
Objectives of the Joint Evaluation Initiative:
- Simplified Registration Process: By conducting joint evaluations, the initiative seeks to reduce duplication of efforts, thereby expediting the approval process for biological products in both Egypt and South Africa.
- Regulatory Harmonization: The collaboration aims to foster mutual recognition of regulatory decisions, enhancing access to medicines and vaccines across both nations.
- Stakeholder Engagement: Industry partners are encouraged to participate in this work-sharing initiative, contributing to the development of harmonized regulatory frameworks and facilitating broader access to essential health products.
Participation Details :
Interested stakeholders are invited to submit their applications using the forms provided and guidelines. Submissions should be directed to the following email addresses:
- EDA: Bioreg.rec@edaegypt.gov.eg
- SAHPRA: eoi@sahpra.org.za
For comprehensive information on the initiative, including the concept note, application form, and operational procedures, please refer to the following links:
- Concept Note : https://www.edaegypt.gov.eg/media/hkhimolc/wsi_concept-note_jtwg-approved-new.pdf
- Application Form (Annex I) : https://edaegypt-my.sharepoint.com/:w:/g/personal/foreign_affairs_edaegypt_gov_eg/EckSN-naE1lMvhfXDYyxG-4B9auIM7GmtGtKU8jJzN7ULg?rtime=xNYxCJei3Ug
- Operational Procedures (Annex II) : https://www.edaegypt.gov.eg/media/tp4jqmsx/wsi_annex-ii_operating-procedures_jtwg-approved-new.pdf
This collaborative effort underscores the commitment of both EDA and SAHPRA to enhance regulatory efficiency and ensure the timely availability of high-quality biological products to their populations.