Transcript WEAB034 – Regulation Of Health Products And Technologies In

Regulation of Pharmaceuticals in
Kenya
Anthony Toroitich,
Pharmacy and Poisons Board (PPB)
Directorate of Product Evaluation & Registration
Presentation Overview

Introduction

Regulatory Framework and Principles

Scope of Health Product Regulation
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Regulation of Clinical trials
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Marketing Authorization Process
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Comparative Overview of Current Pharmaceutical Laws in
EAC
Areas for Legal Harmonization
Introduction
(1)
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Medical Products and Health Technologies (MPHT’s) is an integral part of
the health system in Kenya
An effective healthcare system should
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Provide the public with access to medicines that are of good
quality, safety and efficacy and that are economically affordable.
Must be captured clearly in the national health and
pharmaceutical policies.
Access to medicines becomes even more critical given that
majority of our population live below poverty line and face
serious pandemics such as HIV/AIDS, malaria, drought and
famine.
Introduction
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(2)
Regulation of Medical Products and Health Technologies
(MHPT’s) has developed over the past 50 years in response
to crises.
The initial regulatory standards were primarily related to
ensuring the supply of quality of MHPT’s
Current regulatory developments involve development of
standards for quality, efficacy and safety .
Future EAC Harmonization initiatives
Introduction
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(3)
Pharmaceutical and Health Policy
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Goal and Objective: Universal access to essential health
products and technologies
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by ensuring availability and rational use of safe, good quality,
efficacious/effective and affordable health products and
technologies through appropriate regulation
A key strategy: Pharmaceutical Sector Regulation
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Requires a harmonized regulatory system based on sound science
and evidence
Should cover: human Medicines; vaccines, blood & biologics;
diagnostics, medical devices & technologies; animal & veterinary
Medicines; food products, cosmetics and emerging health
technologies.
Regulatory Principles and Framework (2)
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Pharmacy and Poisons Board was established in 1957 under the
Pharmacy and Poisons Act- Cap 244 of the Laws of Kenya, with the
mandate:
 “to make better provision for the practice and profession of
pharmacy and the trade in pharmaceutical products.”
Principles of Regulation
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Law (CAP 244): are usually written in fairly general terms to meet present and
possibly future needs. Passing new laws is a lengthy process hence enforced by
regulation.
Rules (Regulation): Requiring approval by Cabinet Secretary, more rapidly to
respond to changes and can be altered more easily.
PPB Gazette notices: Public Information for operationalisation of rules
Guidelines: Do not carry the force of law, can be more easily modified and
updated and offer informal information on PPB’s thinking in regard to
implementation of regulations. Guidelines help avoid misinterpretation of and
facilitate compliance with laws and regulations.
Regulatory Principles and Framework (3)
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Critical elements for regulation
depend on Product, usage and
presentation to user.
Stages of regulatory control
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Pre-market control ensure that the
product to be placed on the
market complies with regulatory
requirements i.e. Quality, Safety
and Efficacy/Effectiveness.
Post-market Control
Conception &
Development
Manufacture
Pre-market Control
Labeling
Advertising
Ethical
Marketing
Use
Post-Market Control
Disposal
Key Regulatory Functions of PPB
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Premarket of Medical
Products
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Clinical Trials
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Marketing Authorization
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Medical Products
Evaluation & Registration
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Inspection (+ GMP)
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Good Distribution
Practice

Licensing of pharmaceutical
manufacturers, importers and
distributors
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Post-market of Medical
Products
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Control of importation
of pharmaceuticals
Post Market Surveillance
and Enforcement
Quality Control
Laboratory testing
Pharmacovigilance
(Adverse Drugs
Reactions)
Scope of MPHTs Regulated
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Medicines
 Convectional medicines (Human, Veterinary and
Biological products)
 Complementary/Alternative/Herbal medicines
Dietary Supplements
Medical devices and Borderline products
Legal Framework and Policies Required
 National Policies
 Development & issuance of guidelines
 Pre-market evaluation & approval
Regulation of Clinical trials
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Done during medicine
discovery process
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To determine whether
indications, dosage or even
the age group.
To provide data that
support the registration of
medicines
All clinical trials need to
be carried out according
to the approved
protocols
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Monitored to ensure the
integrity of the data
generated.
Conducted in accordance
with Good Clinical Practice GCP standards: ethical
principles from Helsinki
Declaration
List of PPB Approved clinical
trials @
www.ctr.pharmacyboardkenya.org
Marketing Authorization
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Marketing authorisation (MA) or Registration:
 Permission for a medicinal product to be marketed or
distributed in a country
 Requires pre-market evaluation of Dossier
 Entry in a register and gazetting in a government Gazette
Objective: Protection of consumers against effects of unsafe
and ineffective products
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Availability of the drug is in the public interest
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safety, efficacious and of acceptable quality
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The site and manufacturing operations complies with current
GMP (adapted WHO guidelines)
Marketing Authorization Process
Submission
Yes
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No
Screening
No
Yes
Scheduling
Yes
Review
Yes
Approval
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Yes
Queries
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No
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Yes
Post Marketing Actions
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Receipt of application and
administrative data
recording
Scheduling of Dossiers on
First In-First Out (FIFO)
basis.
Evaluation of dossier – First
and Second or Review by
technical committee/Peer
Review
Re-submission for reevaluation.
Inspection of
manufacturers.
Good Distribution Practice
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Manufacturers, importers and distributors of
MPHTs in must be licensed.
All medicines released onto the market into
Kenya are certified both for quality and GMP
compliance.
Inspectors are available for enforcement and
inspection of premises
Emerging Experts
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A specialized pool of experts in regulatory science is
growing in Kenya, thereby enhancing regulation MPHTs.
They allow best possible scientific decision for the
regulation of MPHTs in Kenya
Experts are chosen on the basis of their scientific expertise
Experts participate as
 members of its scientific advisory committees or
 as members of the assessment teams carrying out the
evaluation of medicines.
Pharmacovigilance and Post market
Surveillance of MPHTs
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All suspected side effects that are reported by patients
and healthcare professionals must be entered into PPB PV
portal,
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PPB web-based information system that collects, manages reports
of suspected side effects of medicines. These data are continuously
monitored in order to identify any new safety information.
PPB has a committee dedicated to the safety of MPHTs. If
there is a safety issue with an MPHTs that is authorised,
patients and healthcare professionals are given guidance
by the committee and regulatory action taken.
In addition to its role in risk assessment, advice and
recommendations to risk management planning and postmarketing surveillance for MPHTs.
Harmonization Update
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The future: we hope to have common legislation, common procedures for
inspection, technical support, meetings, trainings in EAC.
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Pharmaceutical Policy: Different among partner states
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Pre-Market:
 Clinical Trials regulation
 Product Registration and Inspection esp. API/FPP manufacturer regulation
and Inspection; Pre-market Laboratory for Quality Testing
 Product Information and scheduling: Legal Categories for Products, POM
adverts, Internet and electronic media
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Post-Market
 Pharmacovigilance and Post market Surveillance
 National Formulary Development
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Price control
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Regulatory Actions for non compliance
EAC Harmonization Update
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Harmonized Technical Requirements Developed: MER, GMP, IMS & QMS.
Capacity Building for Assessors, GMP ad QMS;
- # of Regional Training: GMP inspectors (1), Dossier Assessment (1) & QMS
(1).
- Joint Assessments
- Joint Inspections in collaboration between WHO and NMRA
NMRA Adoption of Risk Based review approaches: Mutual recognition for
access of essential medicines.
Other Parallel Regional Activities
- FPP focused PIC/S certification inspections of local manufacturers.
- GIZ/PTB project improvement of GMP for local manufacturers.
- Future Harmonized EAC Pharmaceutical Policy, Law, Mutual Recognition
Framework and Information Sharing Agreements for NMRA.
- Future Establishment of EAC Medicine & Food Safety Commission
Questions/Comments
Contacts
 Pharmacy and Poisons Board; Directorate of
Product Evaluation and Registration
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Thank you