Presentation on theme: "Strategies to increase the use of low priced quality generics"— Presentation transcript:
1Strategies to increase the use of low priced quality generics JFDA & HAI Workshop Towards equitable and affordable medicine prices policy in Jordan 4-5 December 2007Strategies to increase the use of low priced quality generics
2بسم الله الرحمن الرحيم Jordan Food and Drug Administration Drug Director Pharmacist Laila Ghazi Jarrar
3Drug 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
4Drug DirectorateThe 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.
5Drug DirectorateRegulation 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.
6Drug DirectorateHealth 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.
7Laws, Bylaws & Guidelines http://www. jfda. jo/ar/Laws/LawInfo. aspx Drug & Pharmacy Law Stemming Criteria:-Drug Registration Criteria- Pharmacovigilance Criteria- Monitoring of Raw material CriteriaDrug Pricing CriteriaManufacturing Sites accreditation CriteriaHerbal Medicine Registration CriteriaHerbal Product Registration CriteriaVitamins & Minerals Registration CriteriaRadiopharmaceuticals Registration CriteriaMedical Device Registration Criteria including Disinfectants & DetergentsCosmetics & Cosmeceuticals Registration CriteriaInfants Milk Formula and their Special FormulaBiological, Vaccines & Sera Products Registration CriteriaDrug Testing Bylaw
8Drug Directorate Includes 8 departments:- Registration Department (Registration Unit, Medical Device & Cosmetics Unit,Pharmacovigilance Unit, Herbal Medicines Unit)Pricing DepartmentInspection & Monitoring Department(Pharmacies & Drug Stores Unit, Manufacturing Sites Unit, Quality Control Unit)Clinical Studies DepartmentRational Drug Use DepartmentNarcotic and Psychotropic Substance ControlImport DepartmentExport Department
9Drug DirectorateA 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.
10Drug Directorate Technical 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 committeeVitamins & Minerals committee.Vaccines and Sera committee.Medical Devices committee.Bioequivalence studies committee.Clinical studies committee.Re-registration of drugs.
11Ensuring the use of Quality Generics Approval of Bioequivalence StudyBioequivalence studies committee2Approval of Bioequivalence StudyBioequivalence studies committeeApprove Line of ProductionAccreditation of pharmaceuticalsites committeeApprove Line of ProductionAccreditation of pharmaceuticalsites committee1Post marketingPharmacovigilance& Lab Test7CPP6LAB TestQCL3Drug PricingPricing committee5Ensuring the use of Quality GenericsApproval of :Technical committee for theregistration of generic drugs4Active substanceManufacturing process of the medicinal productImpurities(Specifications, analytical procedures and analytical validation)ExcipientsPackagingStability
12Inspection 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.The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
13Registration 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 registrationThe purpose of stability testing is to provide evidence on how the quality of an active substance or finished product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the active substance or a shelf life for the finished product and recommended storage conditions.
14Clinical Studies Department has been established to efficiently manage & facilitate all studies needed for granting marketing authorization for both Generics & NCERegarding 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 StudiesInstitutional Review Board Committee IRBClinical Studies CommitteeAuthorization of the conducting authorityAdvanced volunteers Data Base.Inspection visits to ensure that CRO’s are complying with the requirements in terms of their license.Signed consent formInsurance contracthas to be obtained from the Minister of health upon a recommendation from the Clinical Studies Committee for entities complying with the principles of Good Clinical Practice GCP and Good Laboratory Practice GLP.
15Registration Department Post 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.
16Quality Control Lab Pre & 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)
18Pricing DepartmentContinuous 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.
19Import DepartmentImport 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.
20Export DepartmentSince 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 datedExport 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.
21Thank You Ajloun Castle. Qusair Amra. The Fort at Aqaba Shobak Castle The Mosaic at St. GeorgesChurch in MadabaAjloun Castle.The Treasury at PetraThe Temple of Artemis at JerashThe Temple of Artemis at JerashThe Temple of Artemis at JerashThe Temple of Artemis at JerashThank YouThe Roman Theatre in Amman.Qusair Amra.The Fort at AqabaShobak CastleRuins at Umm QaysKarak Castle.