Transcript Good Manufacturing Practice, WHO Prequalification Scheme and

How the African NMRAs are benefiting from the
WHO medicines prequalification programme
(PQP)
Mr. Apollo Muhairwe
Executive Secretary/ Registrar, NDA
Geneva, SWITZERLAND
11tH February 2010
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11 February 2010, Geneva, Switzerland
Scope of Presentation
Introducing NDA Uganda
Why African NMRAs need the PQP
Benefits from PQP
PQP capacity building activities for
NMRAs
Outcomes from PQP collaboration
Future plans
Conclusion
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Introduction of NDA - Uganda
 National Drug Authority (NDA) is an autonomous Medicines Regulatory
Authority for Uganda, established by in 1993 by an Act of parliament.
 It is governed by a board, called the Authority, which operates through
several Expert Committees and the Secretariat.
 The Secretariat is headed by the Executive Secretary who is the Registrar
and secretary to the Authority and all Authority committees.
 The Secretariat is composed of:
– 6 Departments :
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Drug Assessment and Registration (DAR)
Drugs Inspectorate (INSP)
National Drug Quality Control Laboratory (NDQCL)
Drug Information Department (DID) - National Pharmacovigilance centre
Finance Department
Food Safety Desk (New)
– 4 Units: Legal, Human Resource, Audit, Procurement and Quality Management
 NDA has cooperated with the WHO Prequalification of medicines Programme
(PQP) since 2004. We therefore have enough experience to share with you
the benefits of the programme.
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Why African NMRAs need the PQP
 There is still limited access to treatment by millions of
people living with HIV/AIDS, tuberculosis and malaria
 Most countries still experience appearance of substandard
and counterfeit products on their markets
 A number of countries have weak or no Quality Assurance
systems for medicines due to limited resources and
qualified personnel/ Experts
 A lot of money has been invested in procurement but there
are no harmonized quality assurance systems for
procurement organizations involved.
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Benefits from PQP (1)
 PQP provides expertise:
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Detailed and user friendly easy to use Guidelines
In depth review of APIs
Inspection of API manufacturers, not done by some strong NMRAs
In-depth review of clinical/BE data including Inspection of CROs
 Capacity building:
– On the job training:
• NMRA staff participate in assessments together with experts from
PICS/ICH Regions
• 3-months placements in Geneva for hands-on experience in everyday
work of the PQ Programme and WHO.
• Participation as observers in PQ inspections of CROs, API and FPP sites
– Training of NMRA staff through workshops and seminars
– Pre-visit to QC labs to advise on improvements necessary for
prequalification.
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Benefits from PQP (2)
 Stimulates harmonization among
– NMRAs: group assessments have passed on skills and built trust among regulatory
staff from same region. This is the experience in the East African Community (EAC).
– Manufacturers: Experience in submitting PQ dossiers improves appreciation of
regulatory requirements, the quality of dossiers received by NMRAs has improved –
same dossiers as submitted to PQP.
 Platform for mutual recognition and networking
– Has provided hands-on experience on how to collaborated between regulators in
Africa and from ICH or PIC/S countries.
– NMRAs using guidelines adopted from WHO-PQ and who have undergone similar
training are finding it easy to share regulatory information.
 Enhance reputation and public image of NMRAs
– Participation of NMRAs staff in PQ has enhanced the profile of the participating NMRA
and their staff.
– WHO-PQ list has been used to offer exemptions or abbreviated approval by NMRAs
when called for, facilitating quick access to good quality medicines.
 Utilisation of reliable regulatory decisions
– WHOPARs and WHOPIRs are used as references in expedited evaluation
– PQ has provided lessons on how to utilise decisions from other agencies, institutions
and experts without compromising independence and capacity building objectives.
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Benefits from PQP (3)
 Improved capacity for post-marketing quality
monitoring:
– Prequalified labs and related Quality Monitoring Projects has
provided skills in sampling and testing of marketed products,
Development of laboratory quality systems, Training of laboratory
staff , Networking among laboratory analysts in the region.
 Improved capacity and quality of local production
– Training of manufacturers through seminars, workshops.
– Advice through repeated assessment of dossier and GMP
deficiencies at no cost.
– Technical assistance provided to NMRAs and manufacturers
– All training course materials are posted on the web site to assist
manufacturers to prepare quality dossiers and readiness for inspections.
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How have we utilized collaboration with
PQP
 Reviewed and strengthened registration and variation guidelines in
the areas of the requirements for the Active Pharmaceutical
Ingredient (API), Pharmaceutical Development, Efficacy (Clinical
trials and Bioequivalence).
 Reviewed and strengthened assessment procedures including
assessment templates, details in reports and quality assurance
measures (second review).
 Pre-assessment of QC labs in preparation for WHO prequalification
enabled us to improve Quality management Systems in our lab.
 Helped in motivating for strengthening Pharmacovigilance systems
 Improved communication and sharing of medicines information with
other regulators and clients using the website
 Improved our abbreviated assessment procedure for products
already Prequalified and/or registered in ICH regions
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Future plans (1)
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Further strengthen cooperation between NMRAs and PQP
– Work with PQP to disseminate understanding of PQP and
strengthen PQP network by training of local and regional
resource persons to be involved in Prequalification networking
and trainings
– Commitment to continued co-operation with PQP through
involvement of our staff in PQP activities
– To create networks among individual experts in the region
participating in PQ assessment sessions and inspections
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To discuss how PQP can be used as a catalyst for strengthening
the capacity of NMRAs to regulate other medicines (Registration,
GMP enforcement, Quality Control, Market surveillance,
Pharmacovigilance) not under PQP.
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Collaborate with PQP to catalyse harmonisation of regulatory
activities in the EAC and in Africa in general.
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Future plans (2)
 Utilization of risk analysis principles applied by PQ in assessment of
application for registration of products and variations, inspection of
manufacturing sites and analysis of samples
 Strengthen consideration and utilization of reliable regulatory decisions of
other agencies, institutions and experts without compromising national
obligations and the objective of capacity building.
 Work with PQ to establish mechanisms of regular exchange of information
on GMP status of manufacturing sites and assessment outcomes of
products.
 Explore how more NMRA staff can participate in the WHO Prequalification
project.
 Proceed with the process of getting our laboratory prequalified.
 Collaborate with PQP in monitoring the performance of products approved
by WHO and supplied under UN agencies and provide feedback on Drug
quality (Post Marketing Surveillance) and Drug safety (Pharmacovigilance)
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Conclusion
WHO prequalification of medicines programme:
 Is responding to a real need – access to good quality
medicines amidst gaps in QA systems
 Is a vehicle for capacity building of NMRAs in
developing countries
 Is stimulating harmonization among DRAs,
manufacturers and procurement agencies
 Has stimulated improved GMP compliance among
manufacturers – clear target standards with an
assured international market
 Will facilitates international pooled procurements
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END
 Quality must be built into a
medicine and assured
throughout the distribution
and use chain.
 Let us ALL work together to
ensure that only safe,
efficacious and good quality
medicines are available for
use by the patients.
 We are committed to do our
part in this partnership but
we still need your support.
MANY
THANKS TO
PQP
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11 February 2010, Geneva, Switzerland