who prequalification of medicines: a gateway to the global pharmaceutical market introduction 28...
TRANSCRIPT
WHO Prequalification of Medicines:
a gateway to the global pharmaceutical market
Introduction
28 June 2014, Shanghai
Milan Smid
28 June 2014, Shanghai
1.What is WHO prequalification of medicines
2.How it works
3.Why Chinese manufacturers can benefit from participation
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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
WHO Prequalification Programme WHO Prequalification Programme for Priority Essential Medicinesfor Priority Essential Medicines
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• 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/
Categories of medicines invited: urgently needed for treatment programmes
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Invitation for expression of Interest
Dossier and SMF submitted for assessment
Two routes to medicines prequalification
Medicine assessedby SRA
Medicine notassessed by SRA
WHO assessmentand inspections
organized
Compliance Prequalification Acceptance
Simplified review
Valid for innovators and generics
SRA registration (assessment and
compliance check)
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• 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
Standards used to assess and prequalify
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• 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/
Prequalification outcomes are publicly available and provide useful guidance
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• 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
Frequent misunderstandings
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NO
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• Access to APIs• Available infrastructure• Government commitment and pro-export policy• Big internal market, contributing to economy of scale• Technical capability
China medicines manufacture: significant potential, but also weaknesses (substantially simplified)
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• 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
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FPPs prequalified or under assessment: China vs. other countries
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APIs prequalified or under assessment: China vs. other countries
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• 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
Potential benefits for Chinese manufacturers
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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
www.who.int/prequal/info_applicants/collaborative_registration_main.htm
Europe/Asia•Armenia•Georgia•Kyrgyzstan•Ukraine
• Madagascar• Malawi• Mozambique• Namibia• Nigeria
• Tanzania• Uganda• Zambia• Zanzibar• Zimbabwe
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Percentage of finalized procedures according to time bands
Days from accepting supportive PQ data to national registration
