SADC Collaborative Medicines Registration Process (ZAZIBONA) Presentation to SAGMA Workshop 15 August 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 Market Control Economic and industrial interests Public health

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

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.

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

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.

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?

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4|year 10 2 Joint GMP inspections: 4|year ZAZIBONA 40% 22% vs Products with positive vs negative recommendation/withdrawn 12|Average # of products per session 116 products discussed over 10 meetings, 83 finalised from Oct 2013 to Feb 2016, 46 recommended for registration (40%), 26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%)

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

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

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 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

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

Regulators Patients Manufacturers

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