Snapshot

The ZAZIBONA Collaborative Medicines Registration Process - Cost Recovery Pilot pathway has been developed by the Zazibona of Zazibona.

This pathway can be used where medical products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Angola Botswana Comoros Congo, Democratic Republic of the Congo Eswatini Lesotho Madagascar Malawi Mauritius Mozambique Namibia Seychelles South Africa Tanzania Zambia Zimbabwe

When relevant, the agency relies on prior decisions from Australia Brazil Canada China EU-EMA Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States

The pilot is proposed to start towards the end of October 2023. The pilot will be a window in which to receive applications for regional joint assessment without the requirement to submit a product application to any SADC country at that point. This is to align the process with the outcome of the joint review, which is essentially a recommendation based on the comprehensive evaluation of the quality, safety and efficacy of a medical product. Any applicant that envisages applying for Marketing Authorisation to any SADC Member State is eligible to use this voluntary pathway. Screening shall be completed within 14 working days from the date of receipt of the application. The target median time to a ZaZiBoNa recommendation or scientific opinion is 9 months, inclusive of the applicants’ time to respond to queries. Timelines for the collaborative process start at the point of allocation of rapporteurship i.e. within 1 month of the submission, followed by 10 weeks for initial assessment, 2 weeks for sharing assessment report, 8 weeks for the manufacturer/supplier or applicant to respond, and 2 weeks to process the response. The specified timelines are only indicative and may vary depending on the specific dates of the assessment sessions. Products are only considered for 2 review cycles (for the responses) thereafter a final recommendation will be made. It is important to acknowledge that ZAZIBONA has achieved regulatory harmonization but is still on the journey to regulatory convergence. The review process on submission of a product application at country level supported by a positive ZAZIBONA recommendation will be an abridged process that all Active ZAZIBONA Member States have committed to complete within 90 days of receipt of an application. This abridged review will be limited primarily to non-technical issues that still have legislative requirements at country level. Each participating country will publish, by the start of the pilot, the process pathway and requirements for the abridged review, including any exemptions. The ZAZIBONA initiative has further committed to recourse through a discounted fee for a subsequent application where there is failure to meet commitment to this and the other timelines.