JFDA & HAI Workshop Towards equitable and affordable medicine prices policy in Jordan 4-5 December 2007

1. JFDA & HAI WorkshopTowards equitable and affordable medicine prices policy in Jordan4-5 December 2007 Strategies to increase the use of low priced quality generics

2. بسم الله الرحمن الرحيمJordan Food and Drug AdministrationDrug DirectorPharmacist Laila Ghazi Jarrar

3. Drug Directorate Mission Drug Directorate is part of the JFDA which is an independent public sector regulatory institution whose main objectives are to ensure:- • that drugs are safe, efficacious and of good quality. • the safety of products including infants milk formula and their special formula, supplementary food, medicinal plants, natural products, disinfectants and detergents, medical equipment and supplies, pharmaceutical preparations containing vitamins and minerals, cosmetic preparations and any other substances related to treatment or cure of human beings from diseases. The Directorate strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products

4. Drug Directorate • The Drug Directorate was founded year 1973 as one of the Ministry of Health’s main departments, Since then it pursued it’s obligations in compliance with the effective Drug & Pharmacy law. • Drug Directorate works on providing and maintaining proper public health through allocating all possible means and tools to obtain both innovative and generic medicines within a reasonable period of time after ensuring their safety, quality and efficacy.

5. Drug Directorate • Regulation by the JFDA of the marketing, manufacture and distribution of medicinal products plays a very significant role in ensuring that appropriate standards are maintained in this sector. This includes post marketing surveillance, which encompasses pharmacovigilance, investigation of reports of quality defects, and a programme of sampling and analysis (drug Test Bylaw # 48 year 2006). • So Drug Directorate is the only official body that is responsible of medicines which extends throughout the full lifecycle of all products from the starting from Active Pharmaceutical Ingredient until it is ready to be used by the patient as a Finished Product.

6. Drug Directorate • Health professionals and consumers can be assured that JFDA-approved generic drugs have met the same rigid standards as the innovative. All generic drugs are put through a rigorous, multi-step review process that includes a review of scientific data on the generic drug's ingredients and performance.

7. Laws, Bylaws & Guidelineshttp://www.jfda.jo/ar/Laws/LawInfo.aspx?id=748 Drug & Pharmacy Law Stemming Criteria:- Drug Registration Criteria - Pharmacovigilance Criteria - Monitoring of Raw material Criteria Drug Pricing Criteria Manufacturing Sites accreditation Criteria Herbal Medicine Registration Criteria Herbal Product Registration Criteria Vitamins & Minerals Registration Criteria Radiopharmaceuticals Registration Criteria Medical Device Registration Criteria including Disinfectants & Detergents Cosmetics & Cosmeceuticals Registration Criteria Infants Milk Formula and their Special Formula Biological, Vaccines & Sera Products Registration Criteria Drug Testing Bylaw

8. Drug Directorate Includes 8 departments:- • Registration Department (Registration Unit, Medical Device & Cosmetics Unit, Pharmacovigilance Unit, Herbal Medicines Unit) • Pricing Department • Inspection & Monitoring Department (Pharmacies & Drug Stores Unit, Manufacturing Sites Unit, Quality Control Unit) • Clinical Studies Department • Rational Drug Use Department • Narcotic and Psychotropic Substance Control • Import Department • Export Department

9. Drug Directorate • A major strength in managing JFDA is the scientific expertise available to us from several technical committees assigned by the Drug & Pharmacy law #80 and composed of highly qualified technical scientists from both, public and private sectors. • JFDA will continue to utilize this to the best advantage of all stakeholders and to develop a knowledge network of specialists available to advise JFDA in their relevant discipline.

10. Drug DirectorateTechnical Committees • Technical committee for the registration of new drugs. • Technical committee for the registration of generic drugs.       • Pricing committee. • Accreditation of manufacturing sites committee. • Medicinal plants and herbs committee. • Cosmetics committee • Vitamins & Minerals committee. • Vaccines and Sera committee. • Medical Devices committee. • Bioequivalence studies committee. • Clinical studies committee. • Re-registration of drugs.  

11. LAB Test QCL 3 Approve Line of Production Accreditation of pharmaceutical sites committee 1 Approval of Bioequivalence Study Bioequivalence studies committee Approval of Bioequivalence Study Bioequivalence studies committee 2 Approve Line of Production Accreditation of pharmaceutical sites committee Post marketing Pharmacovigilance & Lab Test 7 CPP 6 Drug Pricing Pricing committee 5 Ensuring the use of Quality Generics Approval of : Technical committee for the registration of generic drugs 4 Active substance Manufacturing process of the medicinal product Impurities (Specifications, analytical procedures and analytical validation) Excipients Packaging Stability

12. Inspection Department GMP mandatory for all pharmaceutical production and maintained by JFDA’s well trained inspectors. • Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.. • Registration of a Manufacturing line of production only after ensuring that it is GMP compliant either through documentation or by inspection.( by JFDA inspectors). To assure drug quality, since testing finished product only is not enough anymore.

13. Registration Department • Approving Bioequivalence * studies. - A generic must contain the same active ingredients as the original formulation. - It is considered bioequivalent to the brand name counterpart with respect to phamacokinetic and pharmacodynamic properties. - It is identical in dose, strength, route of administration, safety, efficacy, and intended use. • Approving API/s. • Approving stability profile. NB: Drugs should pass lab testing Carried by JFDA QCL prior to registration

14. Clinical Studies Department has been established to efficiently manage & facilitate all studies needed for granting marketing authorization for both Generics & NCE Regarding clinical studies JFDA/CTU is considered leader in both regional & international levels since it implements all needed elements that ensure the safety and good health of the participating volunteers in any clinical study (therapeutic or non-therapeutic Bioequivalence ) those are:- • Provisional Law No. (97),For the Year 2001,Law of Clinical Studies http://www.jfda.jo/custom/law/23.doc • Institutional Review Board Committee IRB • Clinical Studies Committee • Authorization of the conducting authority • Advanced volunteers Data Base. • Inspection visits to ensure that CRO’s are complying with the requirements in terms of their license. • Signed consent form • Insurance contract

15. Registration DepartmentPost Marketing Role Monitoring post marketing side effects (Pharmacovigilance) Pharmacovigilance unit works on collecting, monitoring, researching, assessing and evaluating information from healthcare providers, patients, local and international Pharmacovigilance centers on the adverse effects of medicines & medical devices with a view to:- - identifying new information about hazards associated with medicines - preventing harm to patients.

16. Quality Control LabPre & Post Marketing Role • Drug Testing Bylaw #48 issued in year 2006 ensured good quality coverage through out the shelf life of drugs since drugs are susceptible for testing at any time unlike the former bylaw. • Also drugs should be tested for two consecutive years and for Seven consecutive batches after which drug will be tested three times yearly upon importation in addition to random sampling (computerized) from the shelves of different outlets (Public or Hospital Pharmacies & Drug stores)

17. Pricing differential

18. Pricing Department Continuous revision of the Jordanian public prices of drugs taking into consideration the following:- • Changes in the currency exchange rates. • Changes in the factors used for calculating the Jordanian public prices of drugs. • Changes in the export prices of drugs to Saudi Arabia. • Reduction in the drug prices in its country of origin. • Reduction in the export price and/or drug prices in its country of origin specified in the imports invoice. • Reduction of the originator drug's price which is reflected on the reduction of its generics so as to maintain their prices less than or equal to 80% of the originator's new price.

19. Import Department • Import department ensures that all imported drugs & JFDA licensed products including Raw Materials Comply with the legal requirements and specification upon which it was granted marketing authorization in Jordan. • Pharmacists audit invoices to verify the compliance of the following information:- • Name and address of the manufacturing company. • Invoice Number and date of issue. • Name and address of the importing party. • Name of the drug, its pharmaceutical form, the container and the concentration, determining if it were a Sample. • Batch Number, production and expiry date and its quantity. • Export currency and rate and method of imports based on Inco Terms. • Country of Origin prices of the Public, the ex-factory and the hospital wherever it may be applicable upon registration. • Issues import statistics which aids local drug manufacturers and drug importers to set their future plans.

20. Export Department Since the Jordanian pharmaceutical industry plays an important role in our national economy and labor market, it is an export driven industry providing high quality, safe and effective pharmaceuticals at affordable prices for millions of people world wide.JFDA board of directors decided to establish a new department specialized in drug exportation by way of resolution number 10 dated 23-2-2006. Export Department duties & responsibilities:- • Issues export statistics which aids local manufacturers to set their future manufacturing plans. • This department will deal with all export measures and related matters. • Facilitate and handle all correspondence with the Jordanian pharmaceutical industry. • Follow and activate bilateral agreements between Jordan and other countries to maintain and develop new markets for our drug exports.

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