1. SADC Collaborative Medicines Registration Process (ZAZIBONA)
Presentation to SAGMA Workshop
15 August 2016

2. Presentation Outline Brief Background Terms of Reference
Objectives of the Collaborative procedure
Progress
ZAZIBONA Process
The Future

3. Brief Background
SADC is a regional economic group with 15 Member States (MS)
Varying regulatory capacities in the region
11 MS actively issue marketing authorizations
Harmonisation of registration of medicines
Directive issued by SADC Ministers of Health in 1999
Work focused on development of technical guidelines (> 22 guidelines developed)

4. The challenge is to achieve balance
                                     
Access
Market Control
Economic and industrial interests
Public health

5. #1 Duplication of effort WHO prequalified
Reviews & inspection by each NMRA
Duplication of effort #1
Approved by well-resourced Authorities

6. African proverb: If you want to go quickly, go alone
African proverb: If you want to go quickly, go alone. If you want to go far, go together.

7. African proverb: A single stick may smoke, but it will not burn.

8. Terms of Reference
Recognized as TWG under SADC Medicines Regulators Forum
Endorsed by SADC Ministers of Health in January 2015
Terms of Reference (ToR) approved by the SADC Ministers of Health 12 Nov 2015
The vision of the ZAZIBONA process in SADC is:
a region in which good-quality medicines are available to all those who need them;   
significantly reduced time taken to grant marketing authorization in the individual countries; and
efficient utilization of resources within regional national regulatory framework through work sharing.

9. Specific Objectives
Initiative to collaborate in assessment and inspections for medicines registrations with objectives to:
Reduce workload
Reduce timelines to registrations
Develop mutual trust and confidence in regulatory collaboration
Platform for training and collaboration in other regulatory fields

10. Is there anything good in this model?

11. ZAZIBONA: Real Work Sharing in Practice!
Since 2013
2| Nos. of HoA meetings/Year
Training Sessions 7
# of Assessment Sessions: 4|year 10 2
Joint GMP inspections: 4|year
ZAZIBONA
40%
22% vs
Products with positive vs negative recommendation/withdrawn
12|Average # of products per session
116 products discussed over 10 meetings, 83 finalised from Oct 2013 to Feb 2016, 46 recommended for registration (40%), 26 for rejection (22%)

12. How does this work ? Consensus Common Submission
Consolidated Assessment reports (CAR)
Consensus
Essential medicine
Consolidated list of Q to applicant
(CLOQ)
Manufacturer’s Consent
4.1 Any medicine meeting the criteria of being an essential medicine is invited for submission to be considered for registration via the ZAZIBONA collaborative process.
4.2 The focus will however be on the 10 priority disease conditions identified by SADC (Annex 1) plus reproductive health products.
Priority will be given to the products included in the List of UN Commission for Live-Saving Commodities for Women and Children.
4.3 Any other medicines that are important from a public health perspective may be considered on a case-by-case basis.
4.4 To be eligible for the ZAZIBONA collaborative process an application should have been lodged with at least half of the participating countries.
4.5 Products registered by stringent regulatory authorities (SRA) are eligible for an abridged review process provided there is access to the assessment reports for which the authorization was based on.
4 CAR
1 Primary Assessment
4↑ Countries

13. Recommend non-approval Recommend approval
Identification of common products
List of common products
Recommend non-approval
Recommend approval
Evaluation of product eligibility
Consolidated AR (CAR) and List of Questions (CLOQ)
Inspection of manufacturing facility
Inspection report
More data required?
Consensus on CAR and CLOQ (TC/plenary)
Product acceptable?
YES
GMP compliant?
Product acceptable ?
Product not acceptable for evaluation
Allocation of rapporteurship
Inform and request consent from manufacturer
Consent provided? NO
Circulation of AR for review
Assessment report (AR)
Assessment of product dossiers
GMP inspection required?
CAPAs, no re-inspection
CAPAs, re-inspection required
Request additional data from manufacturer
Submission of Applications in 2 or more MS NO NO
CAPAs cannot be addressed

14. WHO PQT-m performs QA on the Assessment Reports
Outcomes of Assessments and Inspections would be made available (Transparency on Decision Making)

15. What ZAZIBONA is not… Replacement of the NMRAs Centralised procedure
Only focuses on the review and inspection process
Actual registration is done at the national level i.e., requires actual submission of product application to the countries following applicable national requirements i.e. application fees etc.,
Centralised procedure
There is no central single submission (…yet)
But same dossier submission to all the countries based on the SADC CTD and registration guidelines

16. The future…is bright! Sharing Outcomes
Participation of others (observers/full participation)
Sustainable financing
Model can be applicable elsewhere

17. Regulators
Patients
Manufacturers

18. Acknowledgements ZAZIBONA participating countries
DFID Funded SARPAM Programme
Co-financing the 2014 Work Plan
WHO Prequalification Team – Medicines
Technical & financial Support
SADC Secretariat
11/14/2018