SADC Collaborative Medicines Registration Process (ZAZIBONA) Farai Masekela 13 April 2016
Presentation Outline Brief Background Terms of Reference Objectives of the Collaborative procedure Progress ZAZIBONA Process The Future
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)
The challenge is to achieve balance Access Economic and industrial interests Market Control Public health
WHO prequalified Reviews & inspection by each NMRA Duplication of effort #1 Approved by wellresourced Authorities
If you want to go quickly, go alone. If you want to go far, go together. ~ African proverb
A single stick may smoke, but it will not burn. ~ African proverb
Terms of Reference Recognized as TWG under SADC Medicines Regulators Forum Endorsed by 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 through work sharing.
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
Is there anything good in this model?
2 Nos. of HoA meetings/year ZAZIBONA: Real Work Sharing in Practice! 7 Training Sessions Since 2013 # of Assessment Joint GMP 10 Sessions: 4 year 2 inspections: 4 year 12 Average # of products per session ZAZIBONA 30% vs 20% Products with positive vs negative recommendation/withdrawn
How does this work? Common Submission Essential medicine Manufacturer s Consent Consensus Consolidated Assessment reports (CAR) Consolidated list of Q to applicant (CLOQ) 1 Primary Assessment 4 Countries 4 CAR
CAPAs, no reinspection Request additional data from manufacturer CAPAs, re-inspection required Identification of common products List of common products Evaluation of product eligibility Product acceptable? YES Allocation of rapporteurship NO Submission of Applications in 2 or more MS Product not acceptable for evaluation NO Assessment report (AR) Assessment of product dossiers YES Consent provided? Inform and request consent from manufacturer YES Circulation of AR for review GMP inspection required? YES Inspection of manufacturing facility Consolidated AR (CAR) and List of Questions (CLOQ) NO Inspection report YES Consensus on CAR and CLOQ (TC/plenary) More data required? NO Product acceptable? YES GMP compliant? NO NO CAPAs cannot be addressed Recommend approval YES NO Recommend non-approval
WHO PQT-m performs QA on the Assessment Reports Outcomes of Assessments and Inspections would be made available (Transparency on Decision Making)
What ZAZIBONA is not Replacement of the NMRAs 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
The future is bright! Sharing Outcomes Participation of others (observers/full participation) Sustainable financing Model can be applicable elsewhere
Regulators Manufacturers Patients
Acknowledgements ZAZIBONA participating countries DFID Funded SARPAM Programme Co-financing the 2014 Work Plan WHO Prequalification Team Medicines Technical & financial Support SADC Secretariat 4/14/2016 18