JFDA

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JFDA HAI WorkshopTowards equitable and
affordable medicine prices policy in Jordan4-5
December 2007

• Strategies to increase the use of low priced
  quality generics

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??? ???? ?????? ?????? Jordan Food and
Drug AdministrationDrug DirectorPharmacist
Laila Ghazi Jarrar
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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

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Drug Directorate

• The Drug Directorate was founded year 1973 as one
  of the Ministry of Healths main departments,
  Since then it pursued its 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.

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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.

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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.

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Laws, Bylaws Guidelines http//www.jfda.jo/ar/L
aws/LawInfo.aspx?id748

• 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

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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

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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.

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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.  

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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
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Active substance Manufacturing process of the
medicinal product Impurities (Specifications,
analytical procedures and analytical
validation) Excipients Packaging Stability
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Inspection Department

• GMP mandatory for all
  pharmaceutical production and maintained by
  JFDAs 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.

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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

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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 CROs are
  complying with the requirements in terms of their
  license.
• Signed consent form
• Insurance contract

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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.

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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)

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Pricing differential
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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.

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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.

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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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The Mosaic at St. Georges Church in Madaba
The Treasury at Petra
Ajloun Castle.
The Temple of Artemis at Jerash
The Temple of Artemis at Jerash
The Temple of Artemis at Jerash
The Temple of Artemis at Jerash
Thank You
The Roman Theatre in Amman.
Qusair Amra.
The Fort at Aqaba
Shobak Castle
Karak Castle.
Ruins at Umm Qays