1 JFDA & HAI Workshop Towards equitable and affordable medicine prices policy in Jordan 4-5 December 2007 Strategies to increase the use of low priced.

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JFDA & HAI WorkshopTowards 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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الرحيم الرحمن الله بسم

Jordan Food and Drug Administration

Drug Director

Pharmacist Laila Ghazi Jarrar

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Drug Directorate MissionDrug 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 Regulation by the JFDA of the marketing, manufacture and

distribution of medicinal products plays a very significant role in distribution of medicinal products plays a very significant role in

ensuring that appropriate standards are maintained in this sector. This ensuring that appropriate standards are maintained in this sector. This

includes post marketing surveillance, which encompasses includes post marketing surveillance, which encompasses

pharmacovigilance, investigation of reports of quality defects, and a pharmacovigilance, investigation of reports of quality defects, and a

programme of sampling and analysis (drug Test Bylaw # 48 year 2006)programme of sampling and analysis (drug Test Bylaw # 48 year 2006)..

• So Drug Directorate is the only official body that is responsible of So Drug Directorate is the only official body that is responsible of

medicines which extends throughout the full lifecycle of all products medicines which extends throughout the full lifecycle of all products

from the starting from Active Pharmaceutical Ingredient until it is from the starting from Active Pharmaceutical Ingredient until it is

ready to be used by the patient as a Finished Product.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. Drug Pricing Criteria

3. Manufacturing Sites accreditation Criteria

4. Herbal Medicine Registration Criteria

5. Herbal Product Registration Criteria

6. Vitamins & Minerals Registration Criteria

7. Radiopharmaceuticals Registration Criteria

8. Medical Device Registration Criteria including Disinfectants & Detergents

9. Cosmetics & Cosmeceuticals Registration Criteria

10. Infants Milk Formula and their Special Formula

11. Biological, Vaccines & Sera Products Registration Criteria

12. 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. Pricing Department3. Inspection & Monitoring Department (Pharmacies & Drug Stores Unit, Manufacturing Sites Unit, Quality

Control Unit)

4. Clinical Studies Department5. Rational Drug Use Department 6. Narcotic and Psychotropic Substance Control 7. Import Department8. 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

1. Technical committee for the registration of new drugs.2. Technical committee for the registration of generic drugs.      3. Pricing committee.4. Accreditation of manufacturing sites committee.5. Medicinal plants and herbs committee.6. Cosmetics committee7. Vitamins & Minerals committee.8. Vaccines and Sera committee.9. Medical Devices committee.10. Bioequivalence studies committee.11. Clinical studies committee.12. Re-registration of drugs.  

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Approve Line of ProductionAccreditation of pharmaceutical

sites committee

Approve Line of ProductionAccreditation of pharmaceutical

sites committee1

Approval of Bioequivalence StudyBioequivalence studies committee

Approval of Bioequivalence StudyBioequivalence studies committee

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LAB TestQCL

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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)ExcipientsPackaging Stability

Drug PricingPricing committee

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CPP6

Post marketingPharmacovigilance

& Lab Test7

Ensuring the use of Quality Generics

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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 8. 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

Generics

Locally Manufactured Imported

Local MarketPrice is set to compete

With equivalents available in the market

For ExportPrice is set to the

Maximum to provide a high reference price

The ceiling is either the Price in the country of Origin * or 80% of the

originator Price whichever is less

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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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Ajloun Castle. The Mosaic at St. Georges Church in Madaba The Treasury at Petra

The Temple of Artemis at Jerash

The Roman Theatre in Amman. The Fort at Aqaba Qusair Amra.

Karak Castle. Shobak Castle Ruins at Umm Qays

The Temple of Artemis at Jerash The Temple of Artemis at Jerash The Temple of Artemis at Jerash

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