Regulatory Capacity Building Rutendo Kuwana Medicines Control Authority, Zimbabwe

1. WHO Prequalification of Diagnostics, Medicines and Vaccines - 3rd Consultative Stakeholders MeetingBuilding capacity for regulatory oversight and quality manufacture Regulatory Capacity Building Rutendo Kuwana Medicines Control Authority, Zimbabwe 3rd WHO Prequalification Stakeholders Meeting

2. Objectives (1) • Strengthen national regulatory capacity by provision of training and personal development to experts from NRAs • Strengthen the Member State confidence in the PQP and evaluation of prequalified products by providing extensive exposure into prequalification processes and expertise

3. Objectives (2) • Disseminate understanding of PQP and strengthen Prequalification network by training of local and regional resource persons to be involved in Prequalification networking and trainings • Motivate and stimulate NRAs and trainees to commit themselves to future co-operation with PQP and initiate such co-operation

4. The approach • hands on training by peer reviewed assignments • group and one-to-one discussions • preparation and review of guidelines, SOPs, Templates and Forms • participation in internal and external meetings • participation in and/or making presentation at seminars, workshops and expert committee meetings • Preparation of responses to and correspondences with countries, companies, organizations and individuals

5. Lessons Learnt (1) Most NRAs in Africa should • Constantly review and strengthen medicine registration guidelines particularly for requirements on Active Pharmaceutical Ingredient (API), Pharmaceutical Development, Efficacy (Clinical trials and Bioequivalence) • Review and strengthen assessment procedures including assessment templates, details in reports and quality assurance measures (second/peer review). • Improve product marketing authorisation details to facilitate proper identification of the approved products and facilitate evaluation of variations/amendments. • Utilise risk analysis principles in assessment of marketing authorisation applications, variations, inspection and postmarket surveillance

6. Lessons Learnt (2) • Consider and utilise reliable regulatory decisions of other agencies, institutions and experts without compromising independency and capacity building objectives • Establish documented quality systems and Quality Assurance officer • Use WHO-PQ guidelines and experts to enhance and facilitate regional harmonization – saves resources

7. Lessons from Assessment Meetings (1) • Stimulates harmonization: • Among NRAs by • group assessments pass on skills • readily available, user friendly guidelines - easy to adopt/adapt • Manufacturers • Improve dossiers by use of WHO guidelines for markets that do not have own guidelines • Experience in submitting PQ dossiers improves appreciation of regulatory requirements

8. Lessons from Assessment Meetings (2) • Can be platform for mutual recognition and networking: • Between ICH or PIC/S countries and WHO-PQ • WHO-PQ reference for NRA assessments in DCs • Among NRAs using same guidelines adopted from WHO-PQ and have undergone similar training • Enhance reputation and public image of NRAs • WHO-PQ list can be used to offer any exemptions by DRA when called for • WHOPARs and WHOPIRs used in expedited evaluation

9. Capacity building in PQ Programme • Various approaches: • Training workshops for staff of NRAs • Secondments at WHO • Observers at WHO PQ inspections • Assessors in PQ assessment sessions in Copenhagen

10. Rotational position at WHO HQ • Since November 2006 • Until now four fellows – from Zimbabwe, Uganda, Tanzania and Ethiopia • 3-month hands-on experience in everyday work of the PQ Programme assessment team • Optional participation as observer in inspections • Follow-up plan for implementation at home NRA upon return • Second rotational position will be opened from March 2007