1. No category

JFDA & HAI Workshop
Towards equitable and affordable
medicine prices policy in Jordan
4-5 December 2007
Strategies to increase the use
of low priced quality
generics
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‫بسم هللا الرحمن الرحيم‬
Jordan Food and Drug Administration
Drug Director
Pharmacist 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 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.
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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/Laws/LawInfo.aspx?id=748
Drug & Pharmacy Law Stemming Criteria:1.
Drug Registration Criteria
- Pharmacovigilance Criteria
- Monitoring of Raw material Criteria
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
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:1. Registration Department
(Registration Unit, Medical Device & Cosmetics Unit,
Pharmacovigilance Unit, Herbal Medicines Unit)
2.
3.
Pricing Department
Inspection & Monitoring Department
(Pharmacies & Drug Stores Unit, Manufacturing Sites Unit, Quality
Control Unit)
4.
5.
6.
7.
8.
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 Directorate
Technical Committees
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
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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Approve Line of Production
Approve Line of Production
Accreditation of pharmaceutical
Accreditation of pharmaceutical
sites committee
sites committee
1
CPP
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Approval of Bioequivalence Study
Approval of Bioequivalence Study
Bioequivalence studies committee
Bioequivalence studies committee
2
Post marketing
Pharmacovigilance
& Lab Test
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Drug Pricing
Pricing committee
5
LAB Test
QCL
3
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 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.
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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:1. Provisional Law No. (97),For the Year 2001,Law of Clinical Studies
http://www.jfda.jo/custom/law/23.doc
2. Institutional Review Board Committee IRB
3. Clinical Studies Committee
4. Authorization of the conducting authority
5. Advanced volunteers Data Base.
6. Inspection visits to ensure that CRO’s are complying with the requirements in
terms of their license.
7. Signed consent form
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8. Insurance contract
Registration 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.
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Quality 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)
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Pricing differential
Generics
Locally Manufactured
Local Market
Price is set to compete
With equivalents
available in the market
For Export
Price is set to the
Maximum to provide
a high reference price
Imported
The ceiling is either the
Price in the country of
Origin * or 80% of the
originator Price
whichever is less 17
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. 20
Ajloun Castle.
The Mosaic at St. Georges
Church in Madaba
The Treasury at Petra
The Temple of Artemis at Jerash
Thank You
The Roman Theatre in Amman.
Shobak Castle
The Fort at Aqaba
Ruins at Umm Qays
Qusair Amra.
Karak Castle.
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