WHO update on: Guidelines for the selection of RH medicines and prequalification of priority RH medicines Medicines Policy and Standards Health Technology

WHO update on: Guidelines for the selection of RH medicines and prequalification of priority RH medicines

Medicines Policy and Standards

Health Technology and Pharmaceuticals Cluster

RHSC meeting, New York 27-28 April 2006

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Department of Medicines Policy and Standards. RHSC Meeting, New York 27-28 April 2006

Outline

Interagency lists of essential medicines and medical devices for reproductive health

The PATH/WHO/UNFPA practical guideline for inclusion of essential medicines for RH on national medicines lists

WHO prequalification project for priority RH medicines

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Interagency list of essential medicines for RH, 2006

Published and in distribution process Systematic review of contraceptive medicines initiated:

review of evidence supporting the value of the choice philosophy vs the selection approach of the WHO Expert Committee- final in August 2006

New applications for addition, changes and/or deletion of medicines in the WHO Model List to be submitted by October 2006 (next meeting of the committee March 2007)

Comments and suggestion on the Interagency list essential medicines for RH welcomed

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Interagency list of essential medical devices for RH, 2006

Achieving consistency in the minimum list of medical devices and supplies for common interventions in maternal and RH, including HIV/AIDS commodities

Drafted after 4 interagency consultations: By group of items, according to MNH interventions Use UNICEF nomenclature (UNCCS)

Sent for final review process and will be completed by June 2006

The list will include a glossary of definitions/specifications

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Outline




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Practical guideline for inclusion of essential medicines for RH on national medicines lists

Practical information for all stakeholders at national level to facilitate the integration of medicines for RH into national list

Include 16 medicine briefs, as examples, that gather essential evidence

Field testing of this version planned in 2 countries

Support of the RHSC members in its implementation is crucial

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Outline




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Core list of priority medicines developed and shared with the subgroup on generic manufacturers (January 06) and prior the NY meeting for general agreement

Advocacy of the prequalification process to manufacturers by RHSC is key to increase its value

Experience in past years of prequalification project:

"> 70% of manufacturing sites did not pass in first inspection and > 80% dossiers evaluated do not meet requirements"

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Next steps: Core list of priority medicines completed Support of partners as advocate and agreement to use the

outcomes of the PreQ EOI posted on the PreQ website

http://mednet3.who.int/prequal/

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WHO Prequalification project - Principles

Voluntary for participating manufacturers Based on sound standards - General procedure and standards

approved through WHO Expert Committee system involving all WHO Member States and WHO Governing bodies

Widely discussed• Supported by ICDRA in 2002 and 2004, representing more than

100 national drug regulatory authorities Transparent (all information available on the web site

http://mednet3.who.int/prequal/ ) Open to innovators and multisource/generic manufacturers No cost for applicants – to date

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Objectives

Propose list of prequalified products linked to manufacturing site for quality, efficacy and safety have been assessed, inspected and controlled to meet international norms and standards

Give assurance that international norms and standards are applied at all the steps of the prequalification and at the process itself

Enable and speed up access to good quality of medicines

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Objectives - continued

Follow-up and regular monitoring of the quality of manufacturers and products

Ensure re-qualification and update of the list of prequalified products and manufacturers as new products and manufacturers meet the standards

Ensure the appropriate control of variations and changes

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Objectives - continued

Develop the local capacity for quality productionNational regulatory authorities (NRA) are

involved in dossier assessment and inspectionsProducers receive invaluable specific technical

feedback Help the national NRA to build up capacity in

assessment, inspection and control meeting international norms and standards

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Steps of prequalification

1. Expression of interest (EOI) from a prospective supplier interested in a voluntary participation in the program.

2. Explicative notes and guidelines published on WEB in order to explain how to prepare a product dossier meeting requirements for prequalification.

3. Receipt of the dossier at UNICEF in Copenhagen and Site Master File in WHO Geneva

4. Screening of the dossier, "Quality" part, "Clinical" part and samples

Listed for the possible inspection

5. Assessment of the dossier and writing of assessment report and assessment letter

6. Outcome of evaluation communicated to supplier

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Steps of prequalification cont…

7. Inspection of manufacturing site(s) and follow-up inspection when necessary GMP compliant list of manufacturers

8. Inspection of Research Laboratory or Contract Research Laboratory (CRO) where bioequivalence study has been performed GCP compliant list of CROs

9. Conclusion and listing of product in prequalification list

10. Publication of Public Assessment and Inspection Reports

11. Assessment of the variation when submitted, market survey, de-listing, if necessary

12. Re-qualification after 3 years

Documents

WHO update on: Guidelines for the selection of RH medicines and prequalification of priority RH medicines Medicines Policy and Standards Health Technology