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and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Challenges of Medicine Regulation in Africa
Global Pharmaceutical RegulationMP Matsoso
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Evaluation ®istration
TECHNICAL ELEMENTS
Standards
Norms
Specifications
Guidelines
Procedures
Infrastructure
Finance
Human resources
Policy, legislation, regulations
STRUCTURES ANDADMINISTRATIVE ELEMENTS
Licensing
•Manufacturing•Import•Wholesale•Retail•Dispensing
PremisesPracticesPersons
•Generic drugs•New drug molecules•Clinical trial
Inspection
•Manufacturing•New drug molecules•Clinical trial
Qualitycontrol
•Physico-chemical•Microbiological•Pharmaceutical
Information &Promotioncontrol
Safety & Efficacysurveillance
District
Drugs for human use
Functions& Processes
LEVEL
Central
State/province
Community
Dimensions of Drug Regulation
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Pre-marketing phasePre-marketing phase Post Marketing phasePost Marketing phase
Marketsurveillance
Marketsurveillance
InspectionsInspections
Market distribution
Clinical trialsEthics, GLP;GMP,GCP)
Clinical trialsEthics, GLP;GMP,GCP)
QualityQuality
SafetySafety
EfficacyEfficacy
ProductEvaluation
ProductEvaluation
GMP compliance
GMP compliance
Licensingfacility
Licensingfacility
Laboratory testing
Laboratory testingDossierDossier
Licensing/Registration= evaluation process
Applicants Dossier
Applicants Dossier
Marketing AuthorizationMarketing Authorization
Complexity of Regulatory Processes
Safetymonitoring
Safetymonitoring
VariationsVariations
ApprovalApproval
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Regulatory Gaps: A Global Picture
Developed
Developing a
Developing c1
Developing b
LDC/CPA - a
LDC/CPA - b
1/6 Developed regulatory systems1/2 Varying levels of development & operational capacity1/3 limited or no capacity
193 Member States:
Developing c2
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Regulatory Challenges
• Complexity of Regulatory Processes and requirements has increased
• Limited regulatory capacities in countries• Regulatory delays and backlogs• Lack of specific timelines by MRAs• Lack of requirements that are publicly available
(rapidly evolving technologies, new drug delivery and vaccine delivery technologies)
• Lack of access to appropriate technology
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Integration among regions: An approach
Regional and subregional approaches and global initiatives are considered for:
• Pooling resources, to deal with capacity challenges,• Reducing duplication of effort, redirecting resources • Standardizing requirements• Streamlining regulatory processes• Legal mechanisms to jointly negotiate• Promotion of good governance
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
The case for harmonisation
• Initiatives that are considered for pooling resources• Global Initiatives :
– WHO Prequalification (supports procurement, but has strong regulatory focus)
– DCVRN (vaccine regulatory network of 9 countries established by WHO)
– EU Article 58, Scientific Opinion for medicines exported from EU but not for sale in EU, partnership with WHO
– FDA Tentative approval of PEPFAR linked products, confidentiality agreement with WHO
– ICH GCG- Participation of some subregional blocs, SADC, ASEAN, PANDRA
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Technical Package: Registration
Submission of ApplicationProduct X
Authority A Authority B
Product development
Registration Process
Decision
Registration Process
Decision
ApplicationProduct X
12
Technicalpackage
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Post Marketing: Redirecting resources
– Scientific information after the authorization (variations)
– Post marketing information on quality– Post marketing information on safety and
efficacy– Continuous risk benefit assessment– Strengthened law enforcement capacity
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Opportunities: Harmonisation of Medicine regulation
1. Regulatory package based on WHO guidelines. Assess country and regional capacities and determine roles and functions.
2. Joint assessments, inspections, dossier evaluation and information exchange.
3. Twinning arrangements with more stringent authorities e.g. EMEA, FDA. Maximization of benefits of global initiatives, i.e. Prequalification
4. Harmonize standards and guidelines and medicines lists (paediatrics, reproductive health etc)
5. Strengthen management and administration of regional structures, promote good governance and practices
6. Regional Enforcement activities to fight counterfeits
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
DRA 4
DRA 3
DRA 2
DRA 1
SADC/WHO
DRA 2
DRA 3
DRA 1
SADC/WHO
Sharing basic information: a common data and file repositoryhas been created for participating countries. Limited number of countries for registration package
Adding scope and functionality: additional countries participate and make available selected national medicines registration data
Shared information repository on regulatory and pharmaceutical activities and data
Angola
Botswana
Democratic Republic of Congo
Lesotho
Malawi
Madagascar
Mauritius
Mozambique
Namibia
South Africa
Swaziland
Tanzania
Zambia
Zimbabwe
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
SADC
ACAME
UEMOA COMESA
CEMAC
ECOWAS
EAC
AFDRAN
CEMAC
COMESA
EAC
ECOWAS
SADC
UEMOA
Shared information repository & query system on national registration status of medicines. Connectivity between national registration systems
Facilitating harmonization: countries participate in various subregional activities. Some have developed guidelines, subregional harmonisation plans. Subregional assessments give status of a country within a subregion
and PharmaceuticalsHealth Technology Technical Cooperation for Essential
Drugs and Traditional Medicine
Integration among African countriesProgress• Some countries have removed barriers to trade (e.g. tariffs). May be good to
advocate for removal of taxes and tariffs for essential medicines• Interconnectivity in terms of transport links and telecommunication
(ECOWAS, SADC,CEMAC, UEMOA)• Common purpose and collective action• Main support from WHO working with PartnersDrawbacks• Conflicts• High disease burden• Multiplicity of regional economic communities (duplication, overlaps, waste
of scarce resources)• Transport costs still too high• Slow pace