Transcript The WHO Prequalification of Medicines Programme Capacity building agenda Dr Milan Smid Technical Briefing Seminar October, 2013, Geneva.

The WHO Prequalification of
Medicines Programme
Capacity building agenda
Dr Milan Smid
Technical Briefing Seminar
October, 2013, Geneva
WHO Prequalification of Medicines
Programme
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To increase access to priority medicinal
products of acceptable unified standards
1. Prequalification of medicines (FPPs and APIs)
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Evaluation of quality, safety and efficacy based on submitted
data
Inspections of manufacturers and clinical testing sites
Listing and follow-up of prequalified medicinal products
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Variations, Inspections, Sampling and testing, Requalification
2. Prequalification of Quality Control Laboratories
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Inspections and evaluations
Testing projects
3. Capacity building
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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 - stakeholders
• WHO PQP supports generation of expertise for
development, manufacture, control or regulation
of medicines
Manufacturers
Contract Research Organizations (CROs)
Quality control laboratories (QCLs)
National Regulatory Authorities (NRAs)
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Capacity building – team work
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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Main partners in organization of trainings
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International Pharmaceutical Federation (FIP)
European Directorate for the Quality of Medicines & Healthcare (EDQM)
National Regulatory Authorities in South Africa, Tanzania, Estonia, Ethiopia,
Ukraine, Morocco, Brazil, Jordan, Ghana, Egypt, Indonesia, Kenya, Uganda,
China
National Quality Control Laboratories in Morocco and Tanzania
East Africa Community (EAC)
Association of Southeast Asian Nations (ASEAN)
Ministry of Health China, Pakistan, Iran, Morocco
Program for Appropriate Technology in Health (PATH)
United Nations Population Fund (UNFPA)
European Medicines Agency (EMEA)
Drug Information Association (DIA)
Therapeutic Goods Agency Australia (TGA)
Roche Pharmaceuticals
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Training by doing
• 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
• 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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Conditions for provision of technical
assistance
Manufacturers:
• Found to be capable and willing to improve
• Commitment to participate in the prequalification
programme
• Location in a developing country
Products:
• Inclusion in the list of expression of interest
• Poor representation on the Prequalification list
• Prioritised for Public Health purpose
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Assistances provided in individual
countries 2006-2012
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Technical assistances in WHO regions
2006-2012
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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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Zazibona – ‘look to the future’
(Zambian ‘nyanja’ language)
Pilot of collaborative registration procedure in
four mutually co-operating regulatory authorities
Zambia, Zimbabwe, Botswana and Namibia
Testing the applicability of collaboration in exchange
of assessment and inspection reports on generic
medicines (not submitted for WHO-PQP) among
NMRAs in participating countries
WHO Collaborative Procedure to facilitate and
accelerate registrations of prequalified medicines
Procedure drafted in wide consultation and approved by WHO
advisory expert committee in October 2012. Approved by
WHO Executive Board in May 2013.
Pilot ongoing from June 2012, currently 14 participating
NMRAs from 13 countries.
Europe/Asia
• Uganda
Africa
• Madagascar
•Georgia
• Zambia
• Botswana • Namibia
•Kyrgyzstan
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Zanzibar
• Ghana
• Nigeria
•Ukraine
• Zimbabwe
• Kenya
• Tanzania
www.who.int/prequal/info_applicants/collaborative_registration_main.htm
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Principles of the process
1)
Being asked by PQP holder (manufacturer), PQP
shares full PQP assessment and inspection
outcomes with NMRAs participating in the scheme
and provides advice to facilitate national regulatory
decisions (registrations, variations, withdrawals).
Applicable only for medicines assessed by PQP.
PQP holder provides consent with information
sharing.
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Principles of the process
2)
It is up to discretion of participating NMRAs how
to benefit from shared information. However,
participating NMRAs commit to adopt registration
decision within 90 days from having available full
PQP assessment and inspection outcomes.
NMRAs have the right to
– decline to adopt procedure for individual medicines
– decide differently from PQP, but keep PQP informed
and clarify reasons for deviation.
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Options for participating regulators
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Recognize
Verify
Organize RB second review and inspections
Consider in decision making
Use as quality assurance of national assessment
and decision
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Principles of the process
• Voluntary for manufacturers and NMRAs and does not
interfere with national decision making process and
regulatory fees
• Product and registration dossier in countries are 'the
same' as approved by PQP. Co-operation among PQP
holder (manufacturer), NMRA in interested country and
PQP is necessary to overcome confidentiality issues,
assure information flow and product identity
• 'Harmonized product status' is monitored and maintained
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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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Experience with the procedure
• 13 procedures successfully terminated by
registration in 6 countries:
Ghana 5
Zimbabwe 3
Namibia 2
Kenya 1
Uganda 1
Nigeria 1
• 10 different prequalified products
(9 ARVs, 1 RH)
• 3 companies involved (all Indian)
• None procedure 100% typical
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Learning and challenges
• What is 'the same product' ?
• Applicability for pending national registrations?
• Submissions of reduced registration dossiers in resource
limited settings?
• Use of other languages than English?
• Quality control of registration samples?
• NMRAs administrative capacity and competence?
• Role of NMRAs and Drug Boards?
• Mednet as information system: suitable, but not optimal.
• Synchronization of national and PQ variations?
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Win-win outcomes for all stakeholders
• 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
• Procurers
– Faster start of procurement and wider availability of
PQ medicines
– Assurance about 'the same' medicine as is
prequalified (website)
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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
• WHO
– Prequalified medicines are faster available to patients
– Feed-back on WHO prequalification outcomes
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Status Quo
• The collaborative registration of PQed medicines is in
its infancy, but starts to produce results
• Procedure provides model for inter-regulatory
information exchange to those NMRAs and
manufacturers, who want to cooperate
• Extension of mechanism to SRA approved PQed
products to be explored in co-operation with SRAs
and manufacturers. Extension to 'originators' in
principle not impossible.
Newcomers to the network are
welcome!
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Thank you for the attention
[email protected]
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