Expérience appui ANR Zimbabwe (Medicines Control Authority of Zimbabwe -MCAZ) Corinne Pouget -AEDES

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1 Expérience appui ANR Zimbabwe (Medicines Control Authority of Zimbabwe -MCAZ) Corinne Pouget -AEDES 1

2 Zimbabwe Pharmaceutical Industry The Market Small Country of ca.13 million people Human Pharmaceutical Manufacturers Nine (9) manufacturers excluding Vet manufacturers Contributions Pharmaceutical Manufacturers Association (PMA) Essential Drugs: 46% of Zimbabwe s requirements Employment: 1000 people (pharmacists, engineers, accountants) Exports: SADC region and other Africa countries Extrait d une présentation du MCAZ 2

3 Statut du MCAZ Legal Framework Statutory body: formed by an Act of Parliament (MASCA [15:03] 1969) Enforcement: The Act & The Regulations Regulatory Functions Mandate: Safety, Quality & Efficacy of medicines i.registration of medicines & medical devices ii.licensing of persons & premises iii.control of Clinical Trials Administer the DDA for Secretary for Health (NB: Procurement issues -not MCAZ, but Procurement Agency) Extrait d une présentation du MCAZ 3

4 Statut du MCAZ Financing: MCAZ is a self-financed government agency empowered to levy fees for its services, collect revenue and use it for its operation (since 1 st August 1997). Its predecessor Drugs Control Council of Zimbabwe was a government department financed from the fiscus. 4

5 Objectifs de la mission Mission managée par AEDES pour le Vital Health Support Systems Programme (VHSSP) of the European Commission in Zimbabwe Aider le MCAZ dans son projet de développement de l efficacité et rendement de son QMS Pour l unité Evaluation et Enregistrement (E&R Unit) Pour l inspection Pour le Laboratoire de Contrôle en vue certification ISO 5

6 Déroulement de la mission En 2 phases, chacune avec 2 consultants, 12 jours sur place Évaluation des points forts et faibles Proposition d améliorations en vue objectifs du MCAZ Évaluation des progrès et actions entreprises (après 4 mois) et finalisation plan d actions (court/moyen/long terme) Présentation des recommandations à la direction et au personnel concerné MCAZ, puis rapport détaillé 6

7 Strengths of the system Registration process is logical, appropriate and secure Complemented by QC testing and inspection of sites Described in public documents Committees approve key steps Infrastructure of the QMS is in place; SOPs for main steps and activities exist and are applied 7

8 Strengths of the system Collaboration between services (eg evaluators participate in inspections) Competent staff, appropriately trained, motivated for improvement Steering committee supporting and leading the accreditation process 8

9 Main weaknesses Time for completing registrations too long Overloading the unit work Discouraging applicants Challenging MCAZ reputation Impacting on tenders review process Update of dossiers not assured by insufficient implementation of amendment procedure Unregistered products (exceptional procedure) entering without guarantee or control Responsibility on MCAZ 9

10 Main weaknesses Storage of samples not well managed, in particular for narcotics (not in locked place with documentation of the use) QMS not sufficiently documented and coherent with current practices ; inspection activities not covered Archives chaotic ; security of confidential documents not sufficiently assured Insufficient training, in particular on GCLP Lack of staff (inspection) and high turn-over!!! 10

11 Proposals for improvement Registration process to be attractive and reliable Improving the efficiency of registration process, guaranteeing timelines Limiting the burden due to poor-quality applications Enhancing transparency to stakeholders Unregistered products to be controlled Being confident in delegated QA selection (audit and agreement with UNICEF) Quality control results produced to be reliable and their traceability ensured Reinforcing the GLP practices Starting to implement also the WHO GCLP guidelines

12 Proposals for improvement Inspection to be developed and reinforced Defining a standardized process (described in SOPs) Justifying decisions and inspection programme An adequate MQS involving all MCAZ activities to be developed and kept up-dated Better use of staff competencies Weaknesses reported by consultants to be addressed and a realistic corrective action plan defined and approved by MCAZ Directorate

13 Progress made Before the 2 nd phase Action plan adopted by the Registration Committee and implementation already started Information to stakeholders (industry and distributors); conference in Nov 09 External ISO audit (pre-accreditation) took place and following corrective action plan already prepared 13

14 Progress made up to date Laboratory ISO certified for Chemistry and Medical Devices (Feb 2010) 90% of backlog for registration dossiers is cleared Their perspectives Preparing WHO PQ for Laboratory Strengthening Microbiology Laboratory, vaccine regulation (Lot release and testing) with WHO Geneva And? 14

15 L avis d un des consultants Une agréable atmosphère propice à la collaboration et la transparence Des échanges ouverts et fructueux pour les 2 parties Des personnes motivées, prêtes aux changements car supportés par la Direction Une très bonne réactivité pour la mise en place des actions correctives Des efforts couronnés de succès ce qui renforce la motivation du personnel et celle des consultants!! 15

16 Capacity building is not always synonymous with $$ expenditure, it may be as simple technical assessment of capabilities & needs & arranging an improvement work plan (MCAZ representative) Merci 16

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