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Challenges of Medicine Regulation in Africa

Global Pharmaceutical RegulationMP Matsoso

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Drugs and Traditional Medicine

Evaluation &registration

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

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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

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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

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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

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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

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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

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Technical Package: Registration

Submission of ApplicationProduct X

Authority A Authority B

Product development

Registration Process

Decision

Registration Process

Decision

ApplicationProduct X

12

Technicalpackage

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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

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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

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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

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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

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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