Transcript National Drug Policy Objectives

Jordan Food & Drug
Administration
Background
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As of April, 2003, the Jordan Food and
Drug Administration (JFDA) was
created by law.
The new independent institution (JFDA)
took over the following functions:
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Drug regulatory and quality control
functions.
Food safety and hygiene.
Background
To achieve its function, the following took
place:
1- The following departments were separated
from MOH and became under JFDA
jurisdictions
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Drug Directorate (DD)
Food Directorate (FD)
Quality Control Laboratory (QCL)
Food Laboratories including:
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Amman
Aqaba
Irbid
Background Continued
2. Bilateral agreement signed with the
Ministry of Health that outlines the duties
and responsibilities of each institution.
According to the agreement food and
drug inspection functions remain under
the administrative responsibility of the
MOH and technical supervision by the
JFDA.
Jordan Food and Drug Administration Organizational Chart
Director General
Director of Drug
Legal Office
Asst. to GD for Drug
Information, Research
& QA
Information technology
Director of Drugs
Technical affairs Asst.
Lab affairs Asst.
External Relations office
Asst. to GD for Food
Director of Food
Admin and Finance
Technical affairs Asst.
Human Resources
Drug Lab
Lab affairs Asst.
Finance & Accounting
Food Lab
Research
Narcotics & Psychotropic
Imported Food
Transportation
Consumer awareness
Clinical Research
Domestic Food
Supply & Logistics
Pricing
Cosmetics & Medical Devices
Import/Export
Drug Registration
Registration
Food Establishments
Inspection & monitoring
Drug Factories
Pharmacies & Drug Wholesaler
* The D.G may appoint Consultants on part time or full time basis
Food Additives & special formulas
Units
Pharmacovigilance
Director of Lab services
Departments
Quality improvement.
Consultants*
Director of Food
Directories
Internal Audit
Secretary General for
administrative affairs
Health Minister
Board of Directors
Secretary General
for Technical affairs
Private sector
National Drug Policy Goal
To develop, within the available
financial and human resources,
the potential that drugs have to
improve and maintain the
health of the population.
National Drug Policy Objectives:
1- Ensure that medical needs are covered by
the availability at all times of essential drugs,
vaccines, medical devices, and consumables
for the prevention, alleviation and cure of
diseases at a cost that the individual citizen
and the state can afford.
National Drug Policy Objectives:
2- Ensure the safety, efficacy and
quality of all medicines, vaccines,
medical devices and consumables,
which are available to the general
public in both the public and
private sectors.
National Drug Policy Objectives:
3- Support the national
pharmaceutical industry and
encourage it to develop activities
in line with the essential drugs
concept and also in the research
related activities.
National Drug Policy Objectives:
4- Improve the rational use of drugs
by health professional, mid-level
health care workers and the
general public.
Standing Committees
Director General
Drug Directorate
Higher Drug
Committee
Generic Drug
Registration
Clinical Research
Food Directorate
Originator Drug
Registration
Vitamins and Minerals
Pharmaceutical
Accreditation
Baby Formula
Higher Food
Committee
Permanent committee
On Food Safety
Special Food
and Food Supplements
Medical Devices
Food additives
Medicinal Plants
Pricing
BSE
Cosmetics
Bio-equivalence
RE-Registration
Appeal
Short term plans
1- Archiving and Automation:
Through the World Bank Health Sector
Reform Project, document management
systems software, computer hardware
and heavy duty scanners will be
purchased to archive the huge records
available at the DD.
Short term plans
2- Development of a Dynamic Website that
will enable consumers to:
1. download documents and forms
directly from the JFDA website.
2. Submit application for processing.
3. Track applications and print
approved documents.
Short term plans
3- Expansion of the Risk Based
System (RBS), which is currently
applied in Aqaba, to Queen Alia
International Airport and Amman
Custom Department.
Short term plans
4- Bar Code System and National Drug
Code along with a drug-drug interaction
software in pharmacies. Pharmacies can
link to JFDA website and download
updated lists of drugs along with their
prices.
Short term plans
5- Establishment of a recall and alert
system using cell phone short text
messages (SMS).
Establishment of a consumer awareness
program through SMS messages
targeted to users of prescription drugs.
International Cooperation
1- United States Food & Drug
Administration
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Series of DVCs
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Law
Good Manufacturing Practices
Inspectorate
Conduct of inspections
Laboratory
Visit of Minister of Health and JFDA Director
General to the US Department of Health and
Human Services
US FDA assessment team visited Jordan
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A plan of action was developed and will be implemented
over the coming two years
2- Australian Health Insurance
Commission
1- Reorganization and management of the JFDA.
2- Organization and management of the JFDA Drug Laboratory.
3- Impact of Generic substitution and scenarios for improved generics
use.
4- Scenarios for a change in the pricing structure for drugs.
5- Methodology for the development of Standard Treatment Guidelines.
6- Quantification for drug and supplies in the public sector, and
improved procurement.
7- Improvement of the analysis of annual drug statistics.
8- Analysis of drug utilization in Jordan, and projections for the future.
9- Study for prescription practice.
10-Study of patient compliance.
11-Study of the present and future role of the pharmacist.
3- Australian Food Safety Authority
Signed a bilateral agreement (May,
2004) through which a system of
electronic certification system is used.
 Thus it replaces the need for printed
documents to be validated to confirm
authenticity by the Jordanian
Embassy in Australia prior to
departure of the goods.
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4- European Community
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Twining Grant Agreement in the area of
reforming food inspection services and the
food chain laboratories in Jordan.
Objectives:
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to enable the JFDA to function effectively as a
supervisory and coordinating body.
To enable the inspectorate to function
effectively and efficiently.
To enhance the effectiveness of food chain
laboratories.
5- Republic of Iraq
Signed July 2004
1. Iraqi authorities delegate to JFDA to
apply Jordanian food safety standards and
procedures to Iraqi food shipments.
2. Assist Iraqi authorities in the area of drug
registration, policies, and regulations.
6- WHO Iraq
Under preparation:
Training of Iraqi authorities in the area
of food safety and inspection at:
- Senior managerial level.
- Food inspectors.
7- New Zealand Food Safety
Authority
Official Assurances provided by the
Competent Authorities in the
respective countries in relation to
trade in animal and plant products
intended as food will be accepted
as meeting all requirements for the
importation and trade in such
goods.