Prequalification of Medicines Programme
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1 Prequalification of Medicines Programme TB Alliance Open Forum 4 Key Issues in TB Drug Development Wondiyfraw Z. Worku Technical officer August 18-19, 2010 Addis Ababa, Ethiopia
2 Out line Brief intro to PQP and its activities Paths towards prequalification PQ process flow Expression of interest for prequalification Some numbers Challenges Summary TB Alliance forum 4, Addis Ababa August 2010
3 Description of the PQ programme PQ is a UN programme administered by WHO. According to TRS 953(the revised procedure as approved by WHO expert committee): PQ provides advice on the acceptability in principle of pharmaceutical products for procurement by UN agencies and other agencies. PQ aims to facilitate access to priority essential medicines that meet WHO-recommended norms and standards of acceptable quality. PQ provides list of products of acceptable quality, efficacy and safety TB Alliance forum 4, Addis Ababa August 2010
4 Why PQ is needed Many of the UN and other procurement agencies had no adequate means to ensure quality, efficacy and safety of procured medicines and other medical items. Many of the receiving and exporting countries do not have/did not have well established regulatory system. Need for common and international standards. Increasing demand for generic medicines - several players - substandard products TB Alliance forum 4, Addis Ababa August 2010
5 Organization Like NMRAs, the prequalification programme follows the following strategies: Dossier assessment Inspections of manufacturers and CROs Quality control testing (in many cases post-approval sampling and sometimes also prior to prequalification,) Principally for generic products HIV, Malaria, TB, RH, selected Influenza and medicine for Acute diarrhoea TB Alliance forum 4, Addis Ababa August 2010
6 Organization (cont'd) Differences from other regulatory agencies: - Does not issue marketing authorization. A NMRA authorises a product to be on the market while PQ guides procurement decisions. - Open only to selected medicines - Free of charge - Provides technical assistance to potential applicants - Has also a unit for prequalification of quality control laboratories - Capacity building is part of every activity TB Alliance forum 4, Addis Ababa August 2010
7 Paths for inclusion of a product in the list of prequalified products Prequalification of multisource generic products Full review and inspection by PQP Prequalification of innovators Approval based on marketing authorization issued by a NMRA in ICH region and associated countries Prequalification of generic products approved by SRA Approval based on SRA marketing authorization For established generic products Recognition of temporary approvals / scientific opinions USFDA PEPFAR approval/tentative approval EMA article 58 Hcnda Access programme TB Alliance forum 4, Addis Ababa August 2010
8 Invitation for Expression of Interest issued Submission of dossiers + SMF by interested applicants Simplified representation of the prequalification process Submission of missing data Screening WHO ref No. assigned Submission of additional data Assessment Q and S/E(BE) GMP, GLP and GCP inspections Request for additional data Corrective actions and/or reinspections TB Alliance forum 4, Addis Ababa August 2010
9 Quality and Safety/Efficacy dossier acceptable Consideration for prequalification Acceptable GMP, GLP and GCP Product prequalified= Included in PQ list Publication of WHOPAR Publication of WHOPIR Requalification Variations TB Alliance forum 4, Addis Ababa August 2010
10 Invitation for Expression of interest (EOI) A list of medicines invited for prequalification Priority public health medicines We can only accept product dossiers for medicines included in this list List prepared by WHO clinical departments( HIV, TB, Malaria, RH) Based on inclusion in treatment guidelines and/or WHO model essential drugs list Revised as needed to capture new developments TB Alliance forum 4, Addis Ababa August 2010
11 Products included in the WHO list of prequalified products Total listed as of July 2010: 331 products PQ assessed generics and innovators as of July 2010: 245 products TB Alliance forum 4, Addis Ababa August 2010
12 Current actions being taken to encourage dossier submissions Specific measures to facilitate submission of dossiers for second line TB products Less stability requirement at the time of submission Accepting annual product review report instead of full development and process validation data (if the applicant is already manufacturing the specific product for some time) Growing number of PhInt monographs for first line and second line products Increasing effort for technical assistance in collaboration with other parties (USP's PQM programme, concept foundation) Revision of our main guideline for multi source generic products To harmonize requirements and formats with other regulators (adoption of CTD) Revision of development, process validation and stability requirements for prequalification TB Alliance forum 4, Addis Ababa August 2010
13 Capacity building activities Since 2001, Several assessors and inspectors from developing countries are participating in our assessment and inspection sessions Since 2005/2006, More than 40 technical assistance missions have been organized and delivered More than 50 trainings (for more than 1600 assessors, inspectors and manufacturers) have been delivered We have created a unique 3 month-rotational position within our team for assessors coming from developing countries TB Alliance forum 4, Addis Ababa August 2010
14 Other activities Active participation in the harmonization efforts among African regional initiatives EAC, SADC, etc Joint assessment of 1 HIV and 1 second line TB product dossiers with EAC countries (currently ongoing) Coordinating interim risk assessment procedures for products not yet prequalified or approved by other SRAs. (GFTAM and GDF ERP mechanism) TB Alliance forum 4, Addis Ababa August 2010
15 The future and challenges Increasing demand vs limited capacities Additional therapeutic areas, Medicines for NTDs Prequalification of active pharmaceutical ingredients Continue with capacity building and harmonization activities including joint assessments Shortage of qualified inspectors and assessors Highly dependent on external experts Increasing demand for technical assistance From initial dossier compilation to prequalification GMP compliance TB Alliance forum 4, Addis Ababa August 2010
16 Info rich & user friendly website Procedures & Guidelines List of prequalified products and laboratories Dossier status Notice of concerns & related info Trainings and meetings Public assessment and inspection reports TB Alliance forum 4, Addis Ababa August 2010
17 Summary-PQ Prequalification of priority essential medicines Mainly for multisource generics Recognition of approvals by SRAs Provides technical assistance to manufacturers NMRA capacity building Active participation in harmonization efforts Incorporates a unique procedure for prequalification of laboratories Complete information on the web TB Alliance forum 4, Addis Ababa August 2010
18 Thank you TB Alliance forum 4, Addis Ababa August 2010
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