Transcript The WHO Prequalification of Medicines Programme Capacity building agenda Dr Milan Smid WHO QSM Technical Briefing Seminar 1st November, 2012, Geneva.

The WHO Prequalification of
Medicines Programme
Capacity building agenda
Dr Milan Smid
WHO QSM Technical Briefing Seminar
1st November, 2012, Geneva
PQP capacity building - objectives
• Good quality submissions for PQ supported by compliance
with "good practices"
– platform for improvement of drug development, manufacturing,
documentation and quality control
• Fast regulatory approvals of PQ medicines in recipient
countries
– technical education of regulators as a platform for strengthening
expertise, regulatory efficiency and networking
• Reliable quality monitoring
– technical education of staff of QCLs to strengthen expertise,
effectiveness of quality monitoring and networking
PQP standards and PQP example support strengthening of
regulatory systems and capacity of manufacturers in
general
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Capacity building
team work: WHO HQ, RO, WCO + partners
1) Trainings of
different set-up
and PQ
advocacy
2) Technical
3)
Provision
of
information,
assistance &
standards
and
regulatory
advice
expertise
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1) Trainings - seminars and workshops
– General: PQ procedures and WHO requirements
– Problem oriented, e.g.:
– HIV/AIDS, TB, antimalarial or RH products
– Pharmaceutical development/paediatric dosage forms, BE/BCS
– Manufacture of sterile medicines
– Quality of APIs
– Bioequivalence testing
– Trainings of NRA staff and manufacturers frequently combined
– Collaboration with third parties frequent involved
– Support is given to trainings organized by others
– Focus on "training of trainers"
– WHO training materials used, when available (GMP, GPCL)
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Training by doing for regulators
• Training of regulatory staff by involvement in
PQP activities
– Involvement of assessors from NRAs in PQ
assessment
– Involvement of inspectors from NRAs in PQ
inspections
– Rotations of experts from NRAs in WHO HQ
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2) Technical Assistance
Manufacturers:
• Commitment to participate in the prequalification
programme
• Found to be capable and willing to improve
• Location in a developing country
• Not supported by other international organization
Products:
• Inclusion in the list of expression of interest
• Poor representation on the Prequalification list
• Prioritised for Public Health purpose
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Key objective: Facilitate prequalification
of priority medicines
• Provision of consultants to advice on
– GMP or GCP compliance
– Data development and compilation of dossier
• Assistances are separated from the assessment /
inspections
• Assistances may include specific trainings
• Assistance is provided in principle free of charge
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Assistances provided in individual
countries 2006-2011
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Project of assistance to Nigerian
manufacturers – why Nigeria?
• Pro-active
• Collaborating and committed state authorities
• In Africa one of strongest pharmaceutical sectors, companies
producing and exporting range of products relevant for PQ
• About 70% of medicines imported, donors require PQ
• Companies committed and having common representation
(PGMAN)
• Understanding of financial implications of prequalifying medicinal
products and suggesting solutions
• Able to agree upon 'Project of assistance'
– Strive for prequalification of specific medicines
– Cost sharing
– Follow improvement plans
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3) Provision of information and regulatory
expertise
• Information related to individual PQ products or
manufacturers / CROs http://www.who.int/prequal
–
–
–
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–
–
Product list and pending procedures
Public assessment reports (WHOPAR, SPC, PIL)
Public inspection reports (WHOPIR – APIs and FPPs)
Notice of concern / suspension
Guidelines and standards
PQ laboratories
Training materials
• Published training materials and standards / CDs
• Availability of non-WHO standards (Ph.Eur., ICH)
• Technical Briefing Seminars in Geneva
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Support to rational regulation and
development of regulatory systems
• Concentration on priority issues most relevant for public
health in countries relevant for PQP
• Mostly on invitation of WHO offices or national
governmental institutions
• Improved effectiveness and efficiency of work
• Co-operation with partners and work-sharing
– Facilitated by common standards and administrative
requirements
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WHO Projects Organized in Cooperation
with SFDA in China
Focus on quality and safety of medicines, sponsored by
• Bill and Melinda Gates Foundation (BMGF)
– To improve TB control in China by increasing national
capacity to produce fixed-dose combination (FDC) antiTB medicines of assured quality and to regulate TB
FDC drugs
• Global Fund to Fight HIV/AIDS, TB and Malaria (GFATM)
– To improve the quality of anti-TB, HIV/AIDS and malaria
medicine produced in China to ensure improved
accessibility and patient outcomes
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Generalized objectives of both projects
• Achieve quality assured production of TB FDC, HIV and
malaria drugs in China and strengthen their role on
domestic market and increase export opportunities
• Implement new GMP standards
• Move towards WHO prequalification. WHO prequalification
functions as a gate-keeping mechanism to enter
international tenders and procurement is growing
• No direct financial support to manufacturers through
this project but technical assistance
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Collaboration Procedure between the
WHO Prequalification Programme and
NMRAs
=
Accelerated procedure for registration
of WHO-prequalified medicines
Pilot initiated in June 2012
Procedure approved by WHO Expert Committee for Specifications
of Pharmaceutical Preparations in October 2012
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Background reasoning (1)
• Although WHO prequalified medicines are thoroughly
assessed and manufacturers are inspected according to
WHO/international standards, to be used in recipient
countries they have to be registered by NMRAs.
• Re-assessment and re-inspections of prequalified
medicines place demands on NMRAs.
• Slow registration delays availability to patients.
• Specific national registration requirements sometimes
discourage manufacturers to register and import needed
medicines.
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Background reasoning (2)
• Registration of prequalified medicines may be facilitated
by closer co-operation among WHO, NMRAs and
manufacturers and by provision of full outcomes of PQP
assessment and inspections.
• Prerequisite of facilitated national registration is the
communication of confidential data and therefore
procedure must be well defined and agreed by all
participating parties
• Common assessment and inspections are useful
practice, but not always are applicable
Bangkok, November 2012
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Principles of proposed process
1. Procedure voluntary for manufacturers and NMRAs
and providing benefits to both parties.
2. No interference with national legislation, decision
making process and regulatory fees – availability of
PQP expertise.
3. Being asked by PQP holder (manufacturer), full
PQP assessment and inspection outcomes and
advice will be shared with interested NMRAs to
facilitate national regulatory decisions making
(registrations, variations, withdrawals). Applicable
only for medicines assessed by PQP.
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Principles of proposed process
4. Co-operation among PQP holder (manufacturer),
NMRA in interested country and PQP necessary to
overcome confidentiality issues, assure information
flow and product identity. Registration dossier in
countries in principle the same as approved by PQP.
5. Each participating authority commits to adopt
registration decision within 90 days from having
available full PQP assessment and inspection
outcomes and has the right to
–
–
decline to adopt procedure for individual medicines
decide differently from PQP, but keep PQP informed and
clarify the reasons for deviation.
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Steps of the procedure: agreement
Interested NMRAs agree
to participate in the procedure
and designate focal persons
PQP lists committed NMRAs
on its website and gives to focal
persons access to
restricted-access website
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Steps of the procedure: registration
PQ product is submitted for national registration
to NMRA participating in the procedure
NMRA is informed about the interest to follow PQP
Manufacturer informs PQP about national submission
and
gives consent with information sharing
Participating NMRA confirms its interest to
participate in procedure for specific product
PQP shares with participating NMRA
outcomes of assessment and inspections
Participating NMRA reviews WHO PQP outcomes,
decides within 90 days decides upon the national
registration and informs PQP about its decision
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Steps of the procedure: postregistration
Variations
PQP informs NMRAs
about important variations
NMRAs inform PQP about
variations and decisions leading to
inconsistency with PQP conditions
De-registrations and de-listings
WHO PQP informs NMRA about
withdrawals, suspensions or de-listings
of prequalified medicinal products
NMRAs inform PQP about
national de-registration
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Procedure drafted in wide consultation and
available for comments:
http://www.who.int/entity/medicines/areas/quality_safety/
quality_assurance/PQProcedureassessmentandacceleratednationalreg-QAS12497_01062012.pdf
Pilot testing starting with 10 interested countries:
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Botswana
Ghana
Kenya
Namibia
Nigeria
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Tanzania
Uganda
Zambia
Zanzibar
Zimbabwe
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Win-win outcomes for all stakeholders
• NMRAs
– Availability of WHO assessment and inspection outcomes to
support national decisions and save internal capacities
– Opportunity to learn from PQP assessors and inspectors
– Demonstrating NMRA efficiency
– Having assurance about registration of 'the same' medicine
as is prequalified
– Quality control by same methods and specifications
– Easier post-registration maintenance and pharmacovigilance
• WHO
– Prequalified medicines are faster available to patients
– Feed-back on WHO prequalification outcomes
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Win-win outcomes for all stakeholders
• Procurers
– Faster start of procurement and wider availability of PQ
medicines
– Assurance about 'the same' medicine as is prequalified
• Manufacturers
– Harmonized data for PQ and national registration
– Facilitated interaction with NMRAs in assessment and
inspections
– Accelerated and more predictable registration
– Easier post-registration maintenance
• Ultimate beneficiaries are patients!
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Thank you for the attention
[email protected]
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