1. Regulation of Pharmaceuticals in Kenya
Anthony Toroitich,
Pharmacy and Poisons Board (PPB)
Directorate of Product Evaluation & Registration

2. Presentation Overview
Introduction
Regulatory Framework and Principles
Scope of Health Product Regulation
Regulation of Clinical trials
Marketing Authorization Process
Comparative Overview of Current Pharmaceutical Laws in EAC
Areas for Legal Harmonization

3. Introduction (1) An effective healthcare system should
Medical Products and Health Technologies (MPHT’s) is an integral part of the health system in Kenya
An effective healthcare system should
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.

4. Introduction (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

5. Introduction (3) Pharmaceutical and Health Policy
Goal and Objective: Universal access to essential health products and technologies
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
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.

6. Regulatory Principles and Framework (2)
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
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.

7. Regulatory Principles and Framework (3)
Critical elements for regulation depend on Product, usage and presentation to user.
Stages of regulatory control
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
Labeling
Advertising
Ethical Marketing
Use
Disposal
Pre-market Control
Post-Market Control

8. Key Regulatory Functions of PPB
Premarket of Medical Products
Clinical Trials
Marketing Authorization
Medical Products Evaluation & Registration
Inspection (+ GMP)
Good Distribution Practice
Licensing of pharmaceutical manufacturers, importers and distributors
Post-market of Medical Products
Control of importation of pharmaceuticals
Post Market Surveillance and Enforcement
Quality Control Laboratory testing
Pharmacovigilance (Adverse Drugs Reactions)

9. Scope of MPHTs Regulated
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

10. Regulation of Clinical trials
Done during medicine discovery process
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
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

11. Marketing Authorization
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
Availability of the drug is in the public interest
safety, efficacious and of acceptable quality
The site and manufacturing operations complies with current GMP (adapted WHO guidelines)

12. Marketing Authorization Process
Submission
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 re- evaluation.
Inspection of manufacturers.
Yes No
Screening No
Yes
Yes
Scheduling
Queries
Yes
Review No
Yes
Approval
Yes
Post Marketing Actions

13. Good Distribution Practice
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

14. Emerging Experts
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.

15. Pharmacovigilance and Post market Surveillance of MPHTs
All suspected side effects that are reported by patients and healthcare professionals must be entered into PPB PV portal,
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 post- marketing surveillance for MPHTs.

16. Harmonization Update
The future: we hope to have common legislation, common procedures for inspection, technical support, meetings, trainings in EAC.
Pharmaceutical Policy: Different among partner states
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
Post-Market
Pharmacovigilance and Post market Surveillance
National Formulary Development
Price control
Regulatory Actions for non compliance

17. EAC Harmonization Update
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

18. Questions/Comments Thank you Contacts
Pharmacy and Poisons Board; Directorate of Product Evaluation and Registration
Thank you