Snapshot

The ZAZIBONA Centralized Joint Assessment Pathway for Pharmaceutical Products (ZAZIBONA CP) [July 2025 to December 2026] 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, Kingdom of (Swaziland) Lesotho Madagascar Malawi Mauritius Mozambique Namibia Seychelles, Republic of 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

Target time assessment is Applicants using the CP will receive a scientific opinion on the quality of their product. The scientific opinion serves as a recommendation to the participating Member States. All 16 SADC Member States participate either as Active or Non-Active Member States, based on their internal capacity to conduct assessments and current Good Manufacturing Practice (cGMP) inspections, or as Observers. Positive recommendations can be used by applicants for expedited review and registration with the participating Active Member States at the time of lodging an application for registration (marketing authorization). The Heads of Agencies have made a written commitment to finalize applications supported by a ZAZIBONA CP recommendation within 90 days of submission. OVERVIEW OF THE PROCESS: ZAZIBONA has transitioned into a centralized process for the provision of either a positive or a negative scientific recommendation to the participating Member States on the quality and safety of the product under consideration. The following steps apply to the ZAZIBONA CP: ❖ STEP 1 – NOTIFICATION OF INTENTION TO SUBMIT All applicants intending to utilize the ZAZIBONA Collaborative Procedure (CP) between July 2025 and December 2026 are required to formally notify ZAZIBONA of their intension to submit an application. This notification must be made through the submission of a completed Pre-Submission Form. The Pre-Submission Form should indicate realistic and well-considered, anticipated submission dates. These proposed submission dates should reflect the time point when the applicant has confidence in their ability to submit a complete, high-quality product dossier. Additionally, the form must specify the countries of interest for registration, should the application receive a positive recommendation. Applicants are also expected to commit to commercializing the product within one (1) year of positive recommendation in at least two (2) of the participating Active Member States. ❖ STEP 2 – COMPILATION OF PLANNED SUBMISSION TIMETABLES ZAZIBONA will review the submitted pre-submission forms. ZAZIBONA will then notify applicants, in writing, of their proposed timetable based on the submissions. Submission timetables will be based on the declared intended submission date, and public health priority of the products. Pre-submission meetings will be scheduled where necessary. ❖ STEP 3 – VERIFICATION OF PROPOSED TIMETABLES Applicants will be required to review and formally respond to the proposed submission timetable. Acceptance of the timetable is expected; however, applicants may request modifications or decline the proposed schedule with justifications. The dates for dossier submission and the joint plenary assessment sessions are generally fixed and non-negotiable. Other milestones within the timetable may be subject to adjustment based on mutual agreement and operational feasibility. ❖ STEP 4 – SUBMISSION OF PRODUCT APPLICATION DOSSIERS All product dossiers must be submitted centrally via the ZAZIBONA submission portal and not to the individual Member States. Applicants are required to upload their dossiers along with proof of payment through the portal, in accordance with the agreed submission timetable. ❖ STEP 5 – PROFORMA AND PAYMENT OF SCREENING FEES All applications will undergo an initial screening process prior to evaluation (timeline for screening = 14 working days). The screening and evaluation phases are distinct and sequential. Applicants must ensure that the screening fee is paid in full before uploading the product dossier for assessment. ❖ STEP 6 – SCREENING OUTCOME Products that pass screening will progress to assessment. Applicants will be notified in writing, and the notification will be accompanied by a proforma invoice for the evaluation phase. Products that fail screening will receive a list of deficiencies. Applicants will have 15 days to address these deficiencies. An applicant can pay the screening fee again and resubmit the dossier for screening. Applicants will be allowed up to two (2) screening cycles. ❖ STEP 7 – PRODUCT EVALUATION AND DETERMINATION OF GMP STATUS Assessment of products will only proceed on receipt of proof of payment. Assessment of product(s) submitted will include evaluation of: o product dossiers, which must include product data and information as specified in the SADC guidelines for submission available on the ZAZIBONA website. o manufacturing sites, which must adhere to good manufacturing practices (GMP). Separate cost recovery fees are charged for the GMP determination. o clinical sites (if applicable), which must adhere to good clinical practices (GCP). Applications will be tabled at the quarterly joint assessment sessions. Dates for the quarterly assessment sessions will be published on the ZAZIBONA website along with cut off dates for submissions, to allow applicants to align submissions with meeting dates. The tentative dates for the remainder of 2025 are: o 01 - 05 September o 17 - 21 November Queries will be deliberated on in the joint assessment session and the agreed list of queries communicated centrally. Applicants will be allowed two (2) review cycles, after which a recommendation will be made. An additional cycle may be added in exceptional cases. Requests for extensions on the basis of generating new data will seldom be granted – applicants are advised to submit complete applications from the onset. Compliance with cGMP will be determined either through inspections (on site or remote) or desk review in accordance with prevailing criteria. The specific route will be determined after successful screening. The initial dossier evaluation will also take into account areas of focus. ❖ STEP 8 – COMMUNICATION OF ZAZIBONA RECOMMENDATION The final decision remains a recommendation, which shall be valid for 12 months. A written positive recommendation can be used by the applicant to support expedited review and finalization of the application by any of the member states that have product registration processes within 90days. Applicable country specific requirements are published on the Member State information platforms. These requirements will not be technical in nature. Updating the dossier to reflect clarifications and commitments made during the review cycle shall be a pre-requisite to issuance of the written positive recommendations. Applicants are encouraged to work on this simultaneously as part of the review cycles and part of the mandatory update of the Quality Information Summary (QIS). Only updated dossiers can be submitted for expedited review in seeking registration (marketing authorization) from the participating Member States. ZAZIBONA timeline from receipt of an application as well as the evaluation cost recovery fees to the final recommendation (scientific application shall be no longer than 9months, excluding applicant response time..