Transcript Involvement of countries in the Prequalification Programme

Evaluation of Quality and Interchangeability
of Medicinal Products
Training Workshop for Evaluators
from National Medicines Regulatory
Authorities in East African
Community
Dar Es Salaam, Tanzania
Date: 10 to 14 September 2007
Slide 1 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Evaluation of Quality and
Interchangeability of Medicinal Products
Experience from Participation in the WHO-PQ
Rotational Position
Presenter:
Deus K. Mubangizi, pharmacist, MSc(Pharm.)
[email protected], [email protected]
Chief Inspector of Drugs, National Drug Authority
WHO expert
Slide 2 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Objectives (1)
 Strengthen national regulatory capacity by provision of
training and personal development to experts from
NMRAs
 Strengthen the confidence into PQP and evaluation of
prequalified products by provision of deep insight into
prequalification processes and expertise
 Disseminate understanding of PQP and strengthen
Prequalification network by training of local and regional
resource persons to be involved in Prequalification
networking and trainings
Slide 3 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Objectives (2)
 Identify new contributors to PQP from wide spectrum of
Member States, especially from those Member States
that are using or producing Prequalified products
 Strengthen PQP by trainees who may temporarily
contribute to Prequalification expertise and who may
provide unbiased view on Prequalification processes and
documents
 Motivate and stimulate NRAs and trainees to commit
themselves to future co-operation with PQP and initiate
such co-operation
Slide 4 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
The approach to/method of training and
capacity building

hands on training through doing work which is then peer reviewed

group and one-to-one discussions
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preparation and review of guidelines, SOPs, Templates and Forms

participation in internal and external meetings (The Global Fund, The Global TB
Drug Facility, Roll Back Malaria, MSF)

participation in and/or making presentation at seminars, workshops and expert
committee meetings:
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Introduction of the Model Regulatory Package by TCM
Expert Committee on the Essential Medicine List
Expert Committee on International Non-proprietary Names
Expert Committee on Pharmaceutical Standards, Specification and Guidelines
Expert Committee on Drugs of Dependence
Preparation of responses to and correspondences with countries, companies,
organizations and individuals
Slide 5 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Activities
 Physical and geographical orientation
 Administrative structures and Human Resource matters
 Computer orientation and training
 Orientation meeting/briefings with focal persons of all units in QSM
cluster and related to the PQP (Assessment, Inspection,
Prequalification and Capacity building for QC Laboratories,
Development of Guidelines/Standards/Norms, INN, Essential
Medicine List, Pharmacovigilance, Drugs of Dependence, Capacity
building and Liaison with Counties and other agencies, Fundraising
and liaison with funding agencies, etc)
 Review of Guidelines, SOPs and Templates: the quality system of
the PQP
Slide 6 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Lessons and Recommendations (1)

Review and strengthen our registration guidelines in the areas of the
requirements for the Active Pharmaceutical Ingredient (API), Pharmaceutical
Development, Efficacy (Clinical trials and Bioequivalence)

Review and strengthen our assessment procedures including assessment
templates, details in reports and quality assurance measures (second review).

Develop a Registration Certificate with details that can facilitate the proper
identification of the registered product and facilitate evaluation of
variations/amendments.

Utilization of risk analysis principles in:
– assessment of application for registration of products and variations
– inspection of manufacturing sites
– analysis of samples
Slide 7 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Lessons and Recommendations (2)
 Consideration and utilization of reliable regulatory decisions of
other agencies, institutions and experts without compromising
independency and the objective of capacity building.
 Working towards establishment of a documented quality system
and appointment of a Quality Assurance officer.
 Collaborate with WHO in monitoring the performance of
prequalified products and provide feedback.
 Use WHO-PQ guidelines and experts to enhance and facilitate
harmonization in the EAC and COMESA.
Slide 8 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Lessons from Assessment Meetings
 Stimulates harmonization:
– Among DRAs thru:
 group assessment pass on skills
 readily available, user friendly guidelines easy to adopt/adapt
– Among manufacturers thru:
 Use of similar guidelines for application and assessment
 Joint training seminars and workshops
 Can be platform for mutual recognition and networking:
– Between ICH or PIC/S countries and WHO-PQ
– WHO-PQ reference for DRA assessments in DCs
– Among DRAs using same guidelines adopted from WHO-PQ and have undergone
similar training
 Enhance reputation and public image of DRAs
– Procurement through UN agencies – importation still cleared by DRAs
– WHO-PQ list can be used to offer any exemptions by DRA when called for
– WHOPARs and WHOPIRs used in expedited evaluation
Slide 9 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
THANK YOU
Slide 10 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007