WHO Prequalification of Medicines: a gateway to the global pharmaceutical market Introduction

1. WHO Prequalification of Medicines: a gateway to the global pharmaceutical market Introduction 28 June 2014, Shanghai Milan Smid

2. What is WHO prequalification of medicines • How it works • Why Chinese manufacturers can benefit from participation

3. WHO Prequalification Programme for Priority Essential Medicines Action plan of UN from 2001 for expanding access to selected priority medicines Objective • To ensure quality, efficacy and safety of medicines procured using international funds (e.g. GFTAM, UNITAID) to serve patients in developing countries Components • Evaluation of Quality, Safety and Efficacy of prioritised Essential medicines (FPPs and APIs), inspections of manufacturers and monitoring of the products after their prequalification • Prequalification of quality control laboratories • Building capacity of regulators, manufacturers and quality control laboratories

4. Categories of medicines invited: urgently needed for treatment programmes • Primary categories of medicines: • HIV/AIDS • Malaria • Tuberculosis • Later added: • Reproductive health • Influenza • Acute diarrhoea • Neglected tropical diseases • Potentially other categories of products, e.g. anti-cancer medicines • Prequalification also applicable for APIs! • See Invitations to Manufacturers to Submit an Expression of Interest (EOI) for Product Evaluation on prequalification website http://www.who.int/prequal/

5. Two routes to medicines prequalification Invitation for expression of Interest Medicine assessed by SRA Medicine not assessed by SRA Dossier and SMF submitted for assessment Valid for innovators and generics SRA registration (assessment and compliance check) WHO assessment and inspections organized Simplified review Prequalification Compliance Acceptance

6. Standards used to assess and prequalify • WHO standards as defined in WHO guidelines and International Pharmacopoeia: internationally agreed and publicly available • If these do not exist, ICH guidelines are applied • If needed, guidelines of stringent regulatory authorities, who are involved in ICH process, can be used Technical data accepted by WHO Prequalification are acceptable for regulatory authorities worldwide

7. Prequalification outcomes are publicly available and provide useful guidance • List of Prequalified Medicinal Products • WHO public assessment report (PAR) (summary of product characteristics, patient information leaflet, labelling) • WHO public inspection report (PIR) (both finished pharmaceutical products and active pharmaceutical ingredients) • Notices of Concern and Suspension of Products • Information on products under assessment and inspections • Also available: WHO guidelines, description of PQ procedure, training materials Information in public domain: http://www.who.int/prequal/

8. Frequent misunderstandings NO • Manufacturers/manufacturing sites are prequalified • PQP issues WHO GMP certificates • PQ substitutes national authorization (registration) in recipient countries • Prequalification gives right to succeed in tenders • PQP provides direct financial support • All medicines used in treatment of HIV/AIDS and tropical diseases are invited for PQ

9. China medicines manufacture: significant potential, but also weaknesses (substantially simplified) • Access to APIs • Available infrastructure • Government commitment and pro-export policy • Big internal market, contributing to economy of scale • Technical capability • Capacity to develop and produce new formulations • Available supporting functions (CROs, metrology, standards) • Representation in and experience in developing countries • Workforce cost • Regulatory advice and oversight • Regulatory assurance about quality of exported medicines • Logistics/distribution in importing countries • Communication in foreign languages

10. FPPs prequalified or under assessment: China vs. other countries

11. APIs prequalified or under assessment: China vs. other countries

12. Potential benefits for Chinese manufacturers • Start with API and progress to FPP • Independent on registration by CFDA • Technical assistance possible and free of charge • Facilitation of registrations in many importing countries with the same dossier • No fee for 1st application • Learning process for those who want export • Public recognition affecting position on Chinese market • Verification of international GMP standard and reduction of inspections from importing countries • Gateway for tenders of international procurers

13. WHO Collaborative Procedure to facilitate and accelerate registrations of prequalified medicines Pilot ongoing from June 2012, currently 18 participating NMRAs from 17 countries. • Africa • Botswana • Ethiopia • Ghana • Kenya • Madagascar • Malawi • Mozambique • Namibia • Nigeria • Europe/Asia • Armenia • Georgia • Kyrgyzstan • Ukraine • Tanzania • Uganda • Zambia • Zanzibar • Zimbabwe www.who.int/prequal/info_applicants/collaborative_registration_main.htm

14. Percentage of finalized procedures according to time bands Days from accepting supportive PQ data to national registration

15. Thank You smidm@who.int