ERP mechanism Manufacturers meeting November 2009

ERP process Manufacturers meetingKuala Lumpur November 2009

Expert Review Panel mechanism

Consultative Meeting with Manufacturers of ARVs , Anti-TB and Anti-Malarial Products

23rd – 25th November 2009, Kuala Lumpur, Malaysia

ERP mechanism Manufacturers meeting November 2009

Global Fund revised Quality Assurance policy for Pharmaceuticals

The Board approved the Quality Assurance Policy for Pharmaceutical Products (“QA Policy”) at its 18th Board, November 2008

Standards Option A: WHO prequalifiedOption B: SRA authorizedOption ERP: Products reviewed by a panel of experts- the Expert Review

Panel (ERP)

Expert Review Panel (ERP) TORs were developed and approved by PC members in March 2009

The QA Policy came into effect on 1 July 2009

Amendment to this Policy adopted at the Global Fund at its 20th Board , November 2009


Outline

Expert Review PanelBackgroundMechanismResponsibilitiesCategorization of ERP reviewed productsImplementation of the ERP Problems encountered


The Expert Review Panel

An independent technical body : TORs developed and approved by PC members in March 2009 Established and administered with guidance from WHO for 2 years Composed of external technical experts:

• representative of a wide range of expertise in the pharmaceutical and medical fields

• two members, at least, with recent work experience in an SRA

Purposes: To review the potential risks/benefits associated with the use of

FPPs that are not yet WHO-prequalified or SRA-authorized. To advise the Global Fund in its decision on whether to allow grant

funds to be used to procure FPP


Expert Review Panel (ERP) mechanism

Review of product documentation: at the request of the Global Fund, or in response to GF invitation for EoI to submit dossiers. (based on GF review of products listed in proposals and

partner input)

A product is eligible for review by the ERP if: 1. Application* to WHO Prequalification or application for

marketing authorization to an SRA is accepted for assessment, and

2. Manufacturing site is GMP compliant (SRA / WHO/PICs)

* the criteria 1 can be omitted in specific circumstances


Expert Review Panel (ERP) mechanism ERP will review each submission and advise GF as to

whether the benefits of procurement outweigh the potential quality risks.

Manufacturers will be notified of the outcome of the ERP’s review.

Product eligible for procurement with GF resources (based on ERP advice) Time limited eligibility (maximum 12 months) or until the product is WHO-

prequalified or SRA authorized, whichever is earlier. Possibility of extending the period of eligibility, under certain circumstances

up to an additional 12 months if product is not yet WHO prequalified or SRA authorized.

Contracts to supply products may be concluded any time during the eligibility period


Invitation for Expression of Interest (EoI) Purpose : to invite submissions for ARVS, first-line anti-tuberculosis, Anti

Malarial products which are not yet WHO-prequalified or SRA-authorized, for review by the ERP

Main Goal: to review in advance products which could be purchased by PR when no or only few prequalified products or SRA authorized product are available on the market

The medicines listed in the EOI are : medicines selected in WHO/National treatment guidelines (as per the

Global Fund QA policy requirements) medicines for which less than 3 products currently WHO prequalified

or SRA authorized (according to the information provided by the manufacturers) have been identified

The EoI lists the documents to be submitted by Manufacturers for ERP

review

Published on our web site: http://www.theglobalfund.org/en/procurement/quality/?lang=en

http://www.theglobalfund.org/en/procurement/quality/?lang=en




Responsibilities

The Global Fund Secretariat

ERP :The ERP coordinatorERP members


The Global Fund Secretariat ResponsibilitiesThe GF QA officer

to manage the receipt of product questionnaire dossiers sent by manufacturers according to the EoI

to provide complete product questionnaire and associated documents to the ERP Coordinator for review

to notify manufacturers of the outcome of the ERP’s review of their respective FPP dossiers

to maintain on its website an up-to-date list of FPPs eligible for procurement as per GF QA policy, based on ERP advice


ERP Responsibilities

The ERP coordinator Manages the selection of ERP members according to

the TORs published in the GF website Ensures that ERP members remain current with latest

WHO PQ and SRA guidelines Arranges the timely review of the dossiers received Concludes - based on ERP members’ advice -

regarding the acceptability or non-acceptability for procurement of each specific FPP according to a risk-assessment approach

Drafts the respective communications to the Global Fund and ensures timely delivery of the reports.


ERP members

The nominated ERP members : the data for each FPP will be reviewed by two assessors

Evaluate the data provided in the submissions, Draft the corresponding quality risk assessment

reports, and allocate each product dossier to the appropriate risk category;

Advise the ERP coordinator which products can and which products cannot be considered as acceptable for time-limited procurement based on the evaluation of submitted data;


Technical Areas of ERP review

Product questionnaire dossier :• product registration information;• regulatory (licensing) status of the FPP and manufacturing

facility;• finished product specifications and information regarding

compliance with international pharmacopoeia standards, if available;

• stability testing data (both accelerated and real time studies) as per ICH and/or WHO Guidelines;

• product labelling information;• active pharmaceutical ingredient (API) characteristics and

certification; and • safety and efficacy data for innovator products or human

bioequivalence data for generic products.


Categorization of products reviewed by ERP

The following major product attributes will be used as a basis for comparing the products:

a. GMP status of the manufacturing site - one of the eligibility criteria for ERP review

b. FPP manufacturing process and FPP specificationc. Stability datad. Evidence of therapeutic equivalencee. API source and API quality


Categorization of products reviewed by ERP

Products in Categories 1 and 2 may be considered for time-limited procurement.

Category 3 may be considered for procurement in an

exceptional basis only if there is no other option and the risk of not treating the disease is higher than the risk of using the product.

Products in Category 4 may not be considered for procurement under any circumstances.


Category 1 ProductsCategory Characteristics ERP

adviceApplication of

Global Fund QA Policy

1

The product is described by ALL OF the following:

Product may be considered, for time-limited procurement

Procurement of such product withGlobal Fund resourcesacceptable for a time limited period if less than 2 WHO PQ or SRA authorized products are available.

Product can be listed on the GF website for a time limited period

The product is manufactured at SRA or WHO or PICS GMP compliant site

The FPP is tested with verified compendial tests/methods and validated in-house tests /methods or is tested with acceptable in-house specification and validated test methods.

The submitted data support the claimed shelf life or a minimum of 24 months shelf-life can be assigned (except for products which are inherently unstable )

Acceptable BE study (incl comparator) or multi-media dissolution data (for biowaiver-eligible products) have been submitted.

The API is manufactured by a licensed site, and has acceptable specification. GMP certificate if available.





2

The product is manufactured at SRA or WHO or PICs GMP compliant site

Product may be considered, for time- limited procurement

Procurement of such product with Global Fund resources acceptable for a time limited period if less than 2 WHO PQ or SRA authorized products are available.

Product can be listed onthe Global Fund websitefor a time limited period only if there are less than3 products, including products categorized in category 1, available.

The FPP is tested with verified compendia tests/methods (without additional in-house tests such as related substances, limits of detection and ICH class III residual solvents)

Stability data is submitted for a sufficient test period but test parameters (such as related substancesand loss on drying) may not be complete. However the product is compendia and the related substances and limits of detection are not controlled in the monograph.

BE has been shown against a recommended comparator but source of the comparator is unknown or known to be outside of ICH, or comparator is itself a generic but prequalified by WHO or approved by SRA or PIC/S country.

API is manufactured by licensed site (+GMPcertificate, if available). The specification may not contain full set of tests and limits, but no major quality concern (e.g. residual solvents test for class III).





3

The product is manufactured at SRA or WHO or PICs GMP compliant site and is described by ANY OF the following;

Product may be considered for procurement onlyif there is no other option and the risk of not treating the disease is higher than the risk of using the

product.

Global Fund determines, inconsultation with WHO and other relevant technical partners,if there is no other option, takinginto account relevant factorssuch as country context, evidence of resistance etc. Procurement of such product with Global Fund resources may be permitted on an exceptional basis and for time-limited period only.To be considered on case bycase basis. Because of the exceptionalnature of this categorizationand the likely conditionality onuse, this product will not be listed in the website

Acceptable in-house specification butanalytical methods are not sufficiently

validated BE study not submitted for a product . Not eligible for biowaiver, but multi-media dissolution data show similarity .

BE shown but the comparator product is not acceptable (i.e. not included in PQ comparator list or is a generic which is neither prequalified nor SRA approved).





4

The product is described by ANY OF the following:

Product may not be considered forprocurement under any circumstances.

Procurement of such product not allowed with the Global Fund resources.

Product not listed in the GF website

After verification, it is determined that theproduct is not manufactured at WHO/SRA/PICs GMP compliant site

The specification/analytical validation Is not acceptable for critical test parameter

The current stability data are not satisfactory for products containing unstable APIs and does not allow any assignment of shelf life

Therapeutic equivalence not shown or BE study not acceptable/BE study data not submitted for a product not

eligible for biowaiver.The API specification is not acceptable for critical test parameter


Implementation of the revised QA Policy Progress update

Outcome of First ERP review

Products dossier

reviewed

Permitted Products

(time limited)

Malaria 18 3

Tuberculosis 12 10

HIV 30 15

• Since June 2009, 7 ERP products have been either WHO prequalified or SRA authorized

First Invitation to manufacturers of selected product formulations to submit product dossier for review by ERP for the three diseases

• Publication mid December 2008• Deadline First week of April 2009• ERP review meeting: fist week of May 2009• Outcome of the ERP review sent to Manufactuers: mid June 2009


Implementation of the revised QA Policy Progress update

Outcome of First ERP review

Products dossier

reviewed

Permitted Products

(time limited)

Malaria 8 0

Tuberculosis 3 1

HIV 4 0

Second Invitation to manufacturers of selected product formulations to submit product dossier for review by ERP for the three diseases

• Publication mid July 2009• Deadline for dossier submission: mid September 2009• ERP review meeting: first week of October 2009• Outcome of the ERP review sent to Manufacturers: first week of

November 2009


Next Steps

• Preparation of the Third EoI to be published in December 2009

• Based on the Amendment of the QA policy, additional medicines will be listed :

• Chloroquine• Primaquine• Quinine injectable products• Additional strengths of First line anti TB medicines



36 (36 % of total

ARVs formulations)

4 (17% of total

Anti-TB formulations)

3 (10% of total Antimalarial

formulations)

Product formulations at least 3 FPPs WHO PQ or SRA authorized

1283Product formulations with

ERP recommended product

1430Product formulations with 2

FPP WHO PQ or SRA authorized

34912Product formulations with 1

FPP WHO PQ or SRA authorized

1313 % of total

ARVs formulations

517 % of total Anti TB formulations

16 52% of total Anti-

malarial formulations

Product formulations with no FPP WHO PQ or SRA authorized

ARVs formulations listed on GF list or on GF EoI for ARVs: 98

Anti-TB formulations listed on GF list or on GF EoI for anti-TB products: 23

Antimalarial formulations listed on GF list or on GF EoI for antimalarial products: 31

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ERP mechanism Manufacturers meeting November 2009

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