FOOD AND DRUGS AUTHORITY (FDA) GHANA

Transcription

1 REGULATION OF HERBAL MEDICINE IN GHANA FOOD AND DRUGS AUTHORITY (FDA) GHANA 1

2 PRESENTATION OUTLINE Background Mandate Functions General overview Regulation of Herbal Medicine Cooperation in the ECOWAS region Desired areas for cooperation Achievements 2

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

4 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FDA formerly the Food and Drugs Board (FDB) was established in August 1997 by PNDC Law 305B, 1992 which has been replaced by Public Health Act, 2012 (Act 851) The FDA s mandate in Act 851 Parts 6 (Tobacco Control) Part 7 (Food and Drugs) Part 8 (Clinical Trials) FDA is under the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) 4

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6 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 6

7 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) 7

8 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 8

9 FUNCTIONS 3/4 Product Evaluation and Registration Quality Control Laboratory Analysis Good Manufacturing Practice Inspections Import and Export Control Post Marketing Surveillance 9

10 FUNCTIONS 4/4 Pharmacovigilance Promotion and Advertisement Crisis Management and Public Education Safe Disposal of Unwanted and Expired Products 10

11 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 11

12 Laboratory Services Department Regional Monitoring and Evaluation Regional Offices (9) Import and Export Control Department Port Offices (2) Border Posts General Overview 2/2 Support Services Communication and Public Education, Legal Services, Information Technology, Human Resource and Administration Staff strength

13 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. 13

14 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 14

15 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. 15

16 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

17 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

18 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

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

20 PRE-CLINICAL REQUIREMENTS Toxicological Requirement Acute toxicity Sub acute toxicity Chronic toxicity Sub-chronic toxicity COLLABORATING AGENCIES

21 COLLABORATING INSTITUTIONS CENTRE FOR SCIENTIFIC RESEARCH INTO PLANT MEDICINE MAMPONG KWAME NKRUMAH UNIVERSITY OF SCIENCE AND TECHNOLOGY. SCH. OF PHARM/HERBAL TOXICOLOGICAL STUDIES REPORT NUNGUCHI MEMORIAL INSTITUTE OF MEDICAL RESEARCH UNIVERSITY OF LEGON. PHARMACOLOGY DEPT. KORLEBU 21

22 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

23 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) 23

24 REGISTRATION TRENDS LOCAL HERBAL FOREIGN HERBAL FOOD SUPP

25 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

26 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 26

27 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 27

28 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 28

29 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 29

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31 THANK YOU VERY MUCH VIELEN DANK