REGULATION OF HERBAL MEDICINE IN GHANA FOOD AND DRUGS AUTHORITY (FDA) GHANA

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PRESENTATION OUTLINE Background Mandate Functions General overview Regulation of Herbal Medicine Cooperation in the ECOWAS region Desired areas for cooperation Achievements

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BACKGROUND-GHANA Land borders: 2,093km Population: 26.79 million GDP (2014): $38.65 billion Local herbal manufacturers: 210 Foreign herbal importers: 36 Registered drugs: 851 Life expectancy: 64.22 years 3

BACKGROUND-FDA FDA formerly the Food and Drugs Board (FDB) was established in August 1997 by PNDC Law 305B, 1992 which has been replaced by Public Health Act, 2012 (Act 851) The FDA’s mandate in Act 851

• Parts 6 (Tobacco Control) • Part 7 (Food and Drugs) • Part 8 (Clinical Trials)

FDA is under the Ministry of Health with a Governing Board and two Technical Advisory Committees (Safety Monitoring and Clinical Trials)

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MANDATE The Authority is mandated to regulate

Food, Herbal Medicinal Products, Food supplements, Drugs and Biological Products, Veterinary Products, Homeopathic Medicines, Cosmetics, Medical Devices and Household Chemical Substances Tobacco and Tobacco Products Clinical Trials

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FUNCTIONS 1/4

• Advise the Minister of Health on the preparation of effective Regulations for the implementation of Part 6, 7 and 8 of the Public Health Act, 2012 (ACT 851)

• Monitor through the District Assemblies and any other agency of State compliance with the provisions of Part 6, 7 and 8 of the Public Health Act,2012 (ACT 851)

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FUNCTIONS 2/4

• Ensure adequate and effective standards for regulated products

• Approve the initiation and conduct as well as Monitoring of Clinical Trials

• Perform any other functions that are ancillary to attaining the objects of the Authority

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FUNCTIONS 3/4

Product Evaluation and Registration

Quality Control Laboratory Analysis

Good Manufacturing Practice Inspections

Import and Export Control

Post Marketing Surveillance

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FUNCTIONS 4/4

• Pharmacovigilance

• Promotion and Advertisement

• Crisis Management and Public Education

• Safe Disposal of Unwanted and Expired Products

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GENERAL OVERVIEW 1/2

Food Divisions •Food Inspectorate •Food Safety

Drugs Divisions •Drug Registration and Inspectorate •Safety Monitoring and Clinical Trials •Medical Devices, Cosmetics and Household Chemicals

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Laboratory Services Department Regional Monitoring and Evaluation

• Regional Offices (9)

Import and Export Control Department • Port Offices (2)

• Border Posts Support Services

• Communication and Public Education, Legal Services, Information Technology, Human Resource and Administration

Staff strength 489

General Overview 2/2

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HERBAL MEDICINE REGULATION

Herbal Medicinal Product Regulation Mandated by the Public Health Act 2012, Act 851, Section 118; Definition; Herbal Medicinal Product; Includes plant-derived material preparations with therapeutic or any other human health benefits which contain raw or processed organic ingredients from one or more plant materials with or without animal ingredient.

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GENERAL REQUIREMENTS FOR REGISTRATION 1/2

• Certificate to do business in Ghana Issued by the Registrar Generals Department

• Application letter addressed to the Chief Executive Officer, FDA

• Completed Application Forms with required supporting documentation in CTD format for Allopathic medicine, (in the process of adopting for HMP)

• Samples of the product as per FDA’s sample schedule

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GENERAL REQUIREMENTS FOR REGISTRATION 2/2

• A non-refundable application fee as per Approved Fee Schedule

• Preliminary evaluation and Premises Inspection

For imported products • the exporting company shall notify the

FDA of its local agent in Ghana, • Registration with FDA as Importer.

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QUALITY REQUIREMENTS The quality requirements for herbal medicines should include specifications for the following; Identity (raw material or on Finished product) Microbial purity (at the finished product stage) Chemical purity

QUALITY REQUIREMENTS Identification of the medicinal ingredients should be conducted at the raw material stage as outlined in the pharmacopoeia monographs . Tests conducted include; Physical identification tests (organoleptic evaluation chemical identification test (HPTLC, HPLC) Microbial Testing for the following; Limit of microbial contaminants at the finished product stage

QUALITY REQUIREMENTS Microbial Contaminants should be done according to pharmacopoeia (USP, Ph. Eur. Etc.), WHO methods or any other internationally recognized methods on the following parameters Total viable aerobic plate count Contaminating fungus (yeast & mould) Salmonella spp. Escherichia coli Staphylococcus aureus

QUALITY REQUIREMENTS Chemical Contaminants; Heavy Metal i.e., arsenic (inorganic), cadmium, lead and mercury Pesticide Residues Foreign matters

PRE-CLINICAL REQUIREMENTS

Toxicological Requirement Acute toxicity Sub acute toxicity Chronic toxicity Sub-chronic toxicity COLLABORATING AGENCIES

COLLABORATING INSTITUTIONS

TOXICOLOGICAL STUDIES REPORT

CENTRE FOR SCIENTIFIC RESEARCH INTO PLANT MEDICINE MAMPONG

KWAME NKRUMAH UNIVERSITY OF SCIENCE AND TECHNOLOGY. SCH. OF PHARM/HERBAL

UNIVERSITY OF LEGON. PHARMACOLOGY DEPT. KORLEBU

NUNGUCHI MEMORIAL INSTITUTE OF MEDICAL RESEARCH

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GMP To verify and ensure the right raw materials are used To ensure that the facility complies with minimum cGMP (basic hygiene and sanitary conditions Ensure batch to batch conformity Documentation of processes Recommendations for compliance & follow up

REGISTRATION PROCEDURE1/2

Full Marketing Authority (FMA); based on the safety, quality and efficacy as with any regular medicine when a Herbal preparation contains active ingredients; • That are for life-threatening conditions • That are first time use • That no scientific evidence exist for its use • That are toxic, and requiring special handling NB: justification for efficacy, safety via relevant clinical studies. (Refer to FDA guidelines on clinical trial)

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REGISTRATION TRENDS

479

83

363

578

105

554

678

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391

0

100

200

300

400

500

600

700

800

LOCAL HERBAL FOREIGN HERBAL FOOD SUPP

201420152016

COOPERATION IN THE ECOWAS REGIONS

• Development of West African Herbal Pharmacopeia

• Has been recognized by the WHO as a training centre

• Trained officers from Uganda and Ethiopia under the sponsorship of the WHO

Members in the sub-region (Cote De l’vory coast, Niger, Burkina Faso and Nigeria) for attachment

CHALLENGES; RESEARCH HERBAL LAB.

• To improve and strengthen laboratory capacity to increase testing of Herbal products on the market.

• Capacity to train local industry in herbal Quality control and testing

• Build capacity and skill of FDA laboratories to be able to share technical knowledge and experience with the sub-region

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CHALLENGES; VANISHING HERBAL MATERIAL SOURCES

• ENVIRONMENTAL DEGRADATION – ILIGAL MINING Contamination of herbs with chemical

• CLIMATE CHANGE - vanishing rain forest • OVER HARVESTING – growing number of

manufactures without plantations

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VANISHING HERBAL TRADITIONAL KNOWLEDGE

• Lack of TRUST and confidence in Confidentiality issues

• Property Right and Antitrust issues • Traditional knowledge is not researched

custodians of the Herbal Medicinal Knowledge are not prepared to make available for research

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CHALLENGES; SAFETY MONITORING IN THE HERBAL INDUSTRY

• The believe that Herbal medicines are not harmful

• Recent Stakeholder meeting to stress the need to monitor the safety of HMP by the Industry

• Training in ADR reporting Waiting to see the possible effect

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THANK YOU VERY MUCH

VIELEN DANK