1. Jordan Food & Drug Administration Administration

2. Background As of April, 2003, the Jordan Food and Drug Administration (JFDA) was created by law. As of April, 2003, the Jordan Food and Drug Administration (JFDA) was created by law. The new independent institution (JFDA) took over the following functions: The new independent institution (JFDA) took over the following functions: Drug regulatory and quality control functions. Drug regulatory and quality control functions. Food safety and hygiene. Food safety and hygiene.

3. Background To achieve its function, the following took place: To achieve its function, the following took place: 1- The following departments were separated from MOH and became under JFDA jurisdictions Drug Directorate (DD) Drug Directorate (DD) Food Directorate (FD) Food Directorate (FD) Quality Control Laboratory (QCL) Quality Control Laboratory (QCL) Food Laboratories including:- Food Laboratories including:- Amman Amman Aqaba Aqaba Irbid Irbid

4. Background Continued 2. Bilateral agreement signed with the Ministry of Health that outlines the duties and responsibilities of each institution. According to the agreement food and drug inspection functions remain under the administrative responsibility of the MOH and technical supervision by the JFDA. According to the agreement food and drug inspection functions remain under the administrative responsibility of the MOH and technical supervision by the JFDA.

5. Consultants* Director General Asst. to GD for DrugLegal Office Health Minister External Relations office Asst. to GD for Food Director of Drug Secretary General for Technical affairs Director of Food Private sector Secretary General for administrative affairs Director of DrugDirector of DrugsInternal Audit Information, Research & QA Director of Food Admin and FinanceDirector of Lab services Information technology Quality improvement. Research Consumer awareness Narcotics & Psychotropic Registration Import/Export Pricing Inspection & monitoring Clinical Research Technical affairs Asst. Lab affairs Asst. Technical affairs Asst. Imported Food Domestic Food Food Establishments Food Additives & special formulas Human Resources Finance & Accounting Transportation Supply & Logistics Drug Lab Food Lab Cosmetics & Medical Devices Pharmacovigilance Drug Registration Pharmacies & Drug Wholesaler Drug Factories Board of Directors Directories Departments Units * The D.G may appoint Consultants on part time or full time basis Jordan Food and Drug Administration Organizational Chart

6. National Drug Policy Goal To develop, within the available financial and human resources, the potential that drugs have to improve and maintain the health of the population.

7. National Drug Policy Objectives: 1- Ensure that medical needs are covered by the availability at all times of essential drugs, vaccines, medical devices, and consumables for the prevention, alleviation and cure of diseases at a cost that the individual citizen and the state can afford.

8. National Drug Policy Objectives: 2- Ensure the safety, efficacy and quality of all medicines, vaccines, medical devices and consumables, which are available to the general public in both the public and private sectors.

9. National Drug Policy Objectives: 3- Support the national pharmaceutical industry and encourage it to develop activities in line with the essential drugs concept and also in the research related activities.

10. National Drug Policy Objectives: 4- Improve the rational use of drugs by health professional, mid-level health care workers and the general public.

11. Standing Committees

12. Short term plans 1- Archiving and Automation: Through the World Bank Health Sector Reform Project, document management systems software, computer hardware and heavy duty scanners will be purchased to archive the huge records available at the DD. Through the World Bank Health Sector Reform Project, document management systems software, computer hardware and heavy duty scanners will be purchased to archive the huge records available at the DD.

13. Short term plans 2- Development of a Dynamic Website that will enable consumers to: 1. download documents and forms directly from the JFDA website. 2. Submit application for processing. 3. Track applications and print approved documents.

14. Short term plans 3- Expansion of the Risk Based System (RBS), which is currently applied in Aqaba, to Queen Alia International Airport and Amman Custom Department. 3- Expansion of the Risk Based System (RBS), which is currently applied in Aqaba, to Queen Alia International Airport and Amman Custom Department.

15. Short term plans 4- Bar Code System and National Drug Code along with a drug-drug interaction software in pharmacies. Pharmacies can link to JFDA website and download updated lists of drugs along with their prices.

16. Short term plans 5- Establishment of a recall and alert system using cell phone short text messages (SMS). Establishment of a consumer awareness program through SMS messages targeted to users of prescription drugs. Establishment of a consumer awareness program through SMS messages targeted to users of prescription drugs.

17. International Cooperation

18. Series of DVCs Series of DVCs Law Law Good Manufacturing Practices Good Manufacturing Practices Inspectorate Inspectorate Conduct of inspections Conduct of inspections Laboratory Laboratory Visit of Minister of Health and JFDA Director General to the US Department of Health and Human Services Visit of Minister of Health and JFDA Director General to the US Department of Health and Human Services US FDA assessment team visited Jordan US FDA assessment team visited Jordan A plan of action was developed and will be implemented over the coming two years A plan of action was developed and will be implemented over the coming two years 1- United States Food & Drug Administration

19. 2- Australian Health Insurance Commission 1- Reorganization and management of the JFDA. 2- Organization and management of the JFDA Drug Laboratory. 3- Impact of Generic substitution and scenarios for improved generics use. 4- Scenarios for a change in the pricing structure for drugs. 5- Methodology for the development of Standard Treatment Guidelines. 6- Quantification for drug and supplies in the public sector, and improved procurement. 7- Improvement of the analysis of annual drug statistics. 8- Analysis of drug utilization in Jordan, and projections for the future. 9- Study for prescription practice. 10-Study of patient compliance. 11-Study of the present and future role of the pharmacist.

20. 3- Australian Food Safety Authority Signed a bilateral agreement (May, 2004) through which a system of electronic certification system is used. Signed a bilateral agreement (May, 2004) through which a system of electronic certification system is used. Thus it replaces the need for printed documents to be validated to confirm authenticity by the Jordanian Embassy in Australia prior to departure of the goods. Thus it replaces the need for printed documents to be validated to confirm authenticity by the Jordanian Embassy in Australia prior to departure of the goods.

21. 4- European Community Twining Grant Agreement in the area of reforming food inspection services and the food chain laboratories in Jordan. Twining Grant Agreement in the area of reforming food inspection services and the food chain laboratories in Jordan. Objectives: Objectives: to enable the JFDA to function effectively as a supervisory and coordinating body. to enable the JFDA to function effectively as a supervisory and coordinating body. To enable the inspectorate to function effectively and efficiently. To enable the inspectorate to function effectively and efficiently. To enhance the effectiveness of food chain laboratories. To enhance the effectiveness of food chain laboratories.

22. 5- Republic of Iraq Signed July 2004 Signed July 2004 1. Iraqi authorities delegate to JFDA to apply Jordanian food safety standards and procedures to Iraqi food shipments. 2. Assist Iraqi authorities in the area of drug registration, policies, and regulations. 2. Assist Iraqi authorities in the area of drug registration, policies, and regulations.

23. 6- WHO Iraq Under preparation: Training of Iraqi authorities in the area of food safety and inspection at: Training of Iraqi authorities in the area of food safety and inspection at: - Senior managerial level. - Food inspectors.

24. 7- New Zealand Food Safety Authority Official Assurances provided by the Competent Authorities in the respective countries in relation to trade in animal and plant products intended as food will be accepted as meeting all requirements for the importation and trade in such goods. Official Assurances provided by the Competent Authorities in the respective countries in relation to trade in animal and plant products intended as food will be accepted as meeting all requirements for the importation and trade in such goods.