Good Manufacturing Practice, WHO Prequalification Scheme and

Download Report

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
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 1 of 12
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
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 2 of 12
11 February 2010, Geneva, Switzerland
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 :
•
•
•
•
•
•
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.
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 3 of 12
11 February 2010, Geneva, Switzerland
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.
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 4 of 12
11 February 2010, Geneva, Switzerland
Benefits from PQP (1)
 PQP provides expertise:
–
–
–
–
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.
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 5 of 12
11 February 2010, Geneva, Switzerland
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.
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 6 of 12
11 February 2010, Geneva, Switzerland
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.
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 7 of 12
11 February 2010, Geneva, Switzerland
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
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 8 of 12
11 February 2010, Geneva, Switzerland
Future plans (1)

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

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.

Collaborate with PQP to catalyse harmonisation of regulatory
activities in the EAC and in Africa in general.
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 9 of 12
11 February 2010, Geneva, Switzerland
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)
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 10 of 12
11 February 2010, Geneva, Switzerland
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
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 11 of 12
11 February 2010, Geneva, Switzerland
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
NATIONAL DRUG AUTHORITY - UGANDA
|
Slide 12 of 12
11 February 2010, Geneva, Switzerland