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Prequalification of Medicines Overview & update. Wondiyfraw Z. Worku WHO Prequalification of Medicines Programme Assessors training, Copenhagen January 2011. Agenda. PQP and its activities Paths towards prequalification PQ process flow Some numbers and achievements

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prequalification of medicines overview update

Prequalification of Medicines Overview & update

Wondiyfraw Z. Worku

WHO Prequalification of Medicines Programme

Assessors training, Copenhagen

January 2011

PQP-overview & update January 2011

agenda
Agenda
  • PQP and its activities
  • Paths towards prequalification
  • PQ process flow
  • Some numbers and achievements
  • Our future and challenges
  • Summary

PQP-overview & update January 2011

un prequalification programme for priority essential medicines
UN Prequalification Programme for Priority Essential Medicines
  • A UN action plan since 2001 to expand access to priority essential medicines for
    • HIV, Malaria, TB,
    • RH, selected Influenza products and Zinc products for Acute diarrhoea
  • To ensure quality, safety and efficacy of medicines procured using international funds
    • Propose a list of prequalified products and manufacturers meeting international norms and standards

PQP-overview & update January 2011

un prequalification programme for priority essential medicines4
UN Prequalification Programme for Priority Essential Medicines
    • Also since recently, to propose list of prequalified APIs and their manufacturers
    • Ensure that international norms and standards are applied at all the steps of the Prequalification Programme.
  • Help the national medicine regulatory authorities to build up capacity in assessment, inspection and quality control meeting international norms and standards.
  • Develop local possibilities of manufacturing and clinical studies by offering customized technical assistance.

PQP-overview & update January 2011

un prequalification programme for priority essential medicines5
UN Prequalification Programme for Priority Essential Medicines
  • Principally for generic products
  • Similar programmes run by WHO:
    • Prequalification of Vaccines
      • http://www.who.int/immunization_standards/vaccine_quality/pq_system/en/index.html
    • Prequalification of diagnostic products
      • http://www.who.int/diagnostics_laboratory/evaluations/en/

PQP-overview & update January 2011

why pq
Why PQ?
  • Many of the UN and other procurement agencies lack sufficient means to ensure safety, efficacy and quality of procured medicines and other medical items.
  • Many of the receiving and exporting countries do not have/did not have well established regulatory system.
  • Increasing demand for generic medicines-several players- substandard products
    • A number of reports on sub standard Anti Tb and Malaria products
  • Need for common-international standard.

PQP-overview & update January 2011

similarities with nmras
Similarities with NMRAs
  • Like NMRAs, the prequalification programme performs

- Dossier assessments

- Inspections

- Quality control testing (mostly through post approval sampling)

- Also post approval pharmacovigilance activities (through sister units within EMP/QSM)

PQP-overview & update January 2011

differences from nmras
Differences from NMRAs
  • Priority therapeutic areas
  • Assessments and inspections by international experts
  • Marketing authorization is not issued.
  • Prequalification of APIs
  • Prequalification of quality control laboratories
  • Provides technical assistance to applicants
  • No fees

PQP-overview & update January 2011

prequalification activities
Prequalification activities
  • Prequalification of medicinal products and APIs
    • Review of quality and safety/efficacy documentation
    • Inspection of manufacturing sites and CROs
  • Prequalification of quality control laboratories
    • To identify suitable laboratories for quality testing of products procured using international funds
    • Also for quality survey of products
  • Technical assistance and capacity building
    • Help manufacturers to meet dossier and GMP requirements
    • To build capacity of national medicine regulatory authorities

PQP-overview & update January 2011

slide10

Organogram

PQP-overview & update January 2011

paths for inclusion of a product in the list of prequalified products
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 an 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

PQP-overview & update January 2011

the assessment process
The assessment process
  • Coordinated by Dr. Matthias Stahl,
    • Quality assessors
    • BE assessors
    • Clinical assessors
    • Support staff
  • Six full time in-house and one rotational assessor.
  • More than 50 temporary advisors (pool of external assessors)
  • Six sessions per annum (every other month) here in CPH.
  • More than 30 assessors per session.

PQP-overview & update January 2011

international standards for prequalification
International standards for prequalification
  • Primarily WHO guidance documents and standards
    • PQ main generic and variation guidelines
    • The WHO Bioequivalence and bio waiver guidelines
    • The WHO Stability guideline
    • International Pharmacopoeia
    • WHO GMP and GCP Guidelines
  • ICH guidelines
  • Other guides issued by SRAs such as USFDA and EMA
  • Other recognized pharmacopoeias
    • BP, EP, JP, USP

PQP-overview & update January 2011

process flow

Expression of interest (EOI)

Process flow

Application for prequalification

Dossier, Samples & SMF

Information

requested

Applicant

Screening

Application accepted for assessment

GMP

Review of GMP Certification,

Inspection reports,

Site Master Files (SMF).

Information

requested

Information

requested

Corrective and

preventative actions

Assessment

Applicant

Inspection

Manufacturer

Accepted

Accepted

WHOPIR

Final decision on prequalification

Variations

Complaints

Random sampling

Requalification

WHOPAR

Listing on WHO website

PQP-overview & update January 2011

invitation for expression of interest eoi
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 experts (HIV, TB, Malaria, RH, Influenza, Zinc)
    • Based on inclusion in treatment guidelines and/or WHO model list of essential medicines
  • Revised as needed to capture new developments

PQP-overview & update January 2011

whopar and whopir
WHOPAR and WHOPIR
  • PQ transparency
    • As per WHA Resolution WHA57.14, dated 22 May 2004
    • Also the pipeline (dossier status sheet)
  • WHOPAR
    • Assessment history
    • Discussion on the review outcomes
    • Approved SmPC, PIL and labels
    • Prepared by team of experts (Clinical, BE and Quality assessors)
  • WHOPIR
    • For FPP, API, CRO and QC lab inspections
    • Scope and dates of inspection
    • Summary of observations and findings
    • Conclusion

PQP-overview & update January 2011

variations
Variations
  • Part of the prequalification status maintenance activity
  • To ensure that changes will not negatively impact the product in terms of quality, safety and efficacy
  • Guideline primary based on the EU guide
    • Discussions ongoing on possible revision
  • Mostly handled by in-house assessors
    • Growing activity as the number of prequalified products has increased
    • Time lines shortened

PQP-overview & update January 2011

requalification
Requalification
  • Every 5 years or when requested, as per PQ procedure
  • Guideline adopted by the WHO Expert Committee in 2009
  • Verification of acceptability of the product in terms of
    • current norms and standards
    • consistency of the product quality
  • First set of products have been identified and applicants are requested to submit the necessary data

PQP-overview & update January 2011

prequalification of apis
Prequalification of APIs
  • Procedure approved by the WHO Expert Committee in 2009
    • Separate from the APIMF procedure
      • GMP compliance is mandatory
      • Does not require submission of the corresponding FPP dossier
      • A separate list of prequalified APIs and their manufacturers will be posted on our website
    • Same guideline- PQ Generic guide
  • Launched in October 2010 (as pilot programme)
    • Initially for those APIs for which we already have approved APIMFs
    • Will soon be expanded to invite other APIs included in our EOI
  • Expected to be of importance to NMRAs and procurement agencies

PQP-overview & update January 2011

major achievements in 2010
Major achievements in 2010
  • Revision of our main guideline for multi source generic products
    • To harmonize requirements and formats with other regulators (adoption of CTD)
    • To provide further details to requirements
    • Revision of development, process validation and stability requirements for prequalification
  • Growing number of PhInt monographs
  • Improvement in internal handling of variations
  • High number of prequalified products despite declining submission

PQP-overview & update January 2011

major achievements 2010 contd
Major Achievements 2010, contd
  • Undertook manufacturer survey
  • First manufacturers meeting took place in July 2010
  • Studies to determine the value of PQ to manufacturers (ongoing)
  • Joint assessment of one HIV and one second line TB product dossiers with EAC countries
    • Capacity building and promotion of regional harmonization
    • Facilitating national registration
    • No duplication of efforts
    • Incentive for manufacturers
  • Two products manufactured by Varichem were prequalified

PQP-overview & update January 2011

list of products included in who prequalified products list
List of products included in WHO prequalified products list
  • Prequalified generics and innovators as of December 31st 2010: 252 products (assessed and inspected by PQ)
  • Total listed as of December 31st 2010 (including those listed based on USFDA/EMA/HCnda approvals): 350 products

PQP-overview & update January 2011

inspections
Inspections

PQP-overview & update January 2011

prequalified interested quality control laboratories
Prequalified / interested quality control laboratories

Prequalified QCLs:

  • South Africa, RIIP+CENQAM (2005)
  • Algeria, LNCPP (2005)
  • South Africa, Adcock Ingram (2007)
  • Morocco, LNCM (2008)
  • Kenya, NQCL (2008)
  • India, Vimta Labs (2008)
  • France, CHMP (2008)
  • Vietnam, NIDQC (2008)
  • Kenya, MEDS (2009)
  • Singapore, HSA (2009)
  • Singapore, TÜV (2009)
  • Canada, K.A.B.S. Laboratories (2010)
  • Ukraine, CLQCM (2010)
  • Ukraine, LPA (2010)
  • Peru, CNCC (2010)
  • Uruguay, CCCM (2010)
  • Bolivia, CONCAMYT (2010)

PQP-overview & update January 2011

quality survey of antimalarial medicines in sub saharan africa 2010
Quality survey of Antimalarial medicines in Sub-Saharan Africa 2010

PQP-overview & update January 2011

To evaluate quality of ACTs and Sulfadoxine/Pyrimethamine

Cameroon, Ethiopia, Ghana, Kenya, Nigeria, Tanzania

To estimate quality at different points of the distribution system

To identify possible causes for any findings

To propose possible strategies and implementation plans to address the problems identified by the study

collected samples by products 935 samples
Collected samples by products935 samples

PQP-overview & update January 2011

results
Results

83 samples of PQ products

  • AL (Novartis, Ajanta, Ipca)
  • A&A co-pack (Cipla, Guilin, Ipca)

PQP-overview & update January 2011

quality survey of anti tb medicines
Quality survey of anti TB medicines
  • Armenia, Azerbaijan, Belarus, Kazakhstan, Ukraine, Uzbekistan
    • Countries with high multidrug-resistant and extensively drug-resistant TB
  • Rifampicin caps, Isoniazid tabl/inj, Rifampicin/Isoniazid tablets, Kanamycin inj powder, Ofloxacin tabl/infusion

PQP-overview & update January 2011

results continued
Results continued
  • 38 samples of WHO-prequalified products
  • Isoniazid/Rifampicin tablets
    • 75/150mg, Lupin India (18), Sandoz Private India (17)
    • 30/60mg (2) and 60/60mg (1) Macleods Pharmaceuticals India
  • None of WHO-prequalified products failed to comply with specifications

PQP-overview & update January 2011

technical assistance to applicants
Technical assistance to applicants
  • More than 60 technical assistance missions have been organized and delivered

PQP-overview & update January 2011

trainings
Trainings
  • More than 65 trainings have been delivered

PQP-overview & update January 2011

trainings contd
Trainings (contd)
  • More than 3130 assessors, inspectors and manufacturers have been trained

PQP-overview & update January 2011

rotational post within who pqp team
Rotational post within WHO PQP team
  • A full time P3 position, on rotational basis (one participant every three months)
  • A unique arrangement for assessors from national medicine regulatory authorities (developing countries)
  • Opportunity for further development in regulatory skills and exposure to the WHO Medicines area of work
  • Several assessors from Ethiopia, Kenya, Tanzania, Uganda, Zimbabwe, Zambia and Ukraine have participated.

PQP-overview & update January 2011

the future
The future
  • Additional therapeutic areas may be included
  • Prequalification of API continued
  • Requalification continued
  • Revision of our variation guide
  • Continue with capacity building and harmonization activities including joint assessments
  • Continue with our technical assistance missions

PQP-overview & update January 2011

challenges
Challenges
  • Declining number of submissions
  • Slow progress with respect to RH, TB and Malaria dossiers
  • Increasing demand vs limited capacities
    • Additional therapeutic areas
    • Prequalification of APIs
    • Additional support to procurement agencies (risk assessment for interim procurement decisions)
  • Increasing demand for technical assistance
    • From initial dossier compilation to prequalification
    • GMP compliance

PQP-overview & update January 2011

info rich user friendly website
Info rich & user friendly website
  • Notice of concerns & related info
  • Prequalification lists
  • Procedures & Guidelines
  • Prequalification of APIs
  • Inspection info
  • Trainings and meetings
  • Public assessment and inspection reports

www.who.int/prequal

PQP-overview & update January 2011

summary
Summary
  • Prequalification of priority essential medicines
    • Promoting access to safe, effective and quality medicines
    • Prequalification of APIs and
    • Prequalification of quality control laboratories
    • Provides technical assistance to applicants
    • NMRAs capacity building
  • International standards are applied
  • Assessment and inspections by international experts
  • Mainly for multisource generics and innovator products approved in ICH region
  • Has issued a revised CTD based guideline for multisource pharmaceutical products
    • Can serve as resource document for NMRAs
  • Active participation in regional regulatory harmonization efforts
    • Joint assessments
  • Complete information on the web, transparent
    • www.who.int/prequal

PQP-overview & update January 2011

thank you
Thank you

PQP-overview & update January 2011