Reformation in the Ethiopian Food, medicines and health care Administration and Control Authority

The Ministry of Health is responsible for the accessibility of quality health service to all citizens throughout the country. Although, a number of special programs have been operational, in the last few years, the Primary Health Care quality still requires due attention. However, various challenges, assumptions and bureaucratic hurdles have been hampering the progress in quality health care delivery system. Because of this the health care service was haphazardly regulated inefficiently.
In recognition to the health sector reform in Ethiopia, the regulation of all health care elements are clearly delineated from the provider and purchaser, and is redesigned to provide the public a dramatic result with respect to low cost, short time, high quality, and large amount of service. Accordingly, health and health related services and products quality regulation core process is redesigned in the purpose of protecting the public from any emerging health risks. The core process comprises of four sub-processes and one version. These are:-

  • Regulatory Standards Setting
  • Inspection and Licensing
  • Product Quality Assessment Registration
  • Regulatory Information Delivery
  • Medico Legal Version process
In accordance with Food, Medicine and Health Care Administration and Control Proclamation No. 661/2009, the Authority is provided with a mandate to regulate the 4Ps (Practice, Premises, Professionals and Products). In addition to this, all elements that need to be regulated are mentioned here. All these regulatory activities are decentralized and functional throughout all regions and woredas of the country.
  • Practice: Health care practices
  • Premises: Which includes, Healthcare facilities, Food establishments, Medicine Facilities, Health related Facilities, Port inspection sites and Health related facilities
  • Professional: all Health professionals
  • Product: From production up-to consumption of Medicines, Medical equipments and devices, Food and Food supplements, Herbal products, Cosmetics, Complimentary and traditional Medicines.
The staff composition in the Authority includes public health professionals, nurse, medical laboratory technologist, environmental health professional, general medical practitioner, health science professional, pharmacist, data administrator, librarian, Agro-chemist, health science technician, medical equipment maintenance engineer and Information technologist. The authority is structured into Managerial and Enforcement wings which helps to promote the check and balance between different directorates. Its mandates are clearly stated in a proclamation 661/2009. The council of Ministers has approved the naming of the regulatory Authority as the “Ethiopian Food, Medicine and Health care Administration and Control Authority” The vision; mission, objectives, and powers and duties of the authority are shown below. Vision “Quality health services and products to all citizens.” Mission “To promote and protect the public health by ensuring safety and quality of products and health service through registration, licensing and inspection of health professionals, pharmaceuticals food establishments and health institutions and provision of up-to-date regulatory information while promoting rational medicine use.”

Objectives

  • To establish and maintain an effective and efficient quality assurance, market authorization, inspection and licensing system.
  • To ensure safety, efficacy and quality of medicines including complimentary and traditional medicines
  • To ensure that food consumed are safe, quality, sanitary and free of contaminants
  • To standardize health services and protect the public from unqualified and unethical professionals and substandard health institutions
  • To ensure an uninterrupted regulatory information provision and promote Rational Medicines use

Power and Duties

  • Set standards for food safety and quality; safety, efficacy, quality and proper use of medicines; competence and practice of health professionals; hygiene and environmental health; competence of health and health related institutions and ensure their implementation and observance
  • Issue, renew, suspend, revoke or deny certificate of competence for specialized health institutions, food or medicines processing plants, quality control laboratories, importer, exporters, storage or distributors and trans-regional health service institutions
  • Initiate policy to strengthen food, medicines, health professionals and health institutions quality and efficiency; initiate draft legislation and forward the same for approval;
  • Serve as medicines, food, health professionals and health and health related institutions information center
  • Identify ingredients that caused death or ill health due to medicines residue or adulteration of medicines and food and take appropriate measures by conducting investigation on sample ingredients
  • Organize quality control laboratories as needed to carry out its duty;
  • Give import or export permit for food, medicines, raw materials and packaging materials and undertake dead bodies control and give entry or exit permit
  • Prepare list of medicines for the country, structure the medicines in the list into different categories, revise the list whenever necessary
  • Evaluate and issue, renew, suspend, revoke or deny registration certificate for medicines
  • Undertake and coordinate post marketing surveillance in order to ensure the safety and quality of food and safety, efficacy and quality of medicines that are put into use and take appropriate measures
  • Authorize conducting clinical trial, monitor the process, evaluate the results and authorize the use of the result in such a way that it benefits the public; as well as cause to suspend or stop the clinical trial
  • Monitor and control manufacture, import, export, distribution, prescribing, dispensing, use, recording and reporting of narcotic drugs, psychotropic substance and precursor chemicals, prevent their abuse as well as report the same to the International Narcotic Control Board
  • Regulate the content, manufacture, import, export, distribution, sales, use, packaging and labeling, advertisement and promotion, and disposal of tobacco products
  • Undertake inspection on plane entering the country and undertake fumigation and give certificate for plane departing the country
  • Undertake control of communicable diseases at entry and exit port on international travelers, prohibit entry, exit or to be quarantined where relevant, and ensure the relevant prevention and control of trans-regional communicable diseases is done
  • Evaluate and issue, renew, suspend, revoke or deny license for scarce health professionals, complementary or alternative medicines practitioners and health professionals coming privately or in group from abroad to deliver health service
  • Ensure proper disposal of expired and unfit for use food, medicines and their raw materials
  • Ensure handling and disposal of trans-regional solid and liquid wastes from different institutions are not harmful to public health
  • Monitor and control illegal food, medicines and health services and take appropriate measures
  • ensure the quality of trans-regional water supply for the public is up to the standard
  • Control, monitor and ensure the availability of necessary hygienic requirements in health related institutions under the federal government;
  • Provide appropriate capacity support to regions on food, medicines and healthcare regulatory bodies with a view to harmonizing federal and regional regulatory system
  • Perform other lawful activities as may be necessary for the attainment of its objectives

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