Drug Directorate
******************
The most important directorate that deals with the drug from its early
stages as raw materials synthesizing ,through all manufacturing processes and
ending up with a finished product ready to be used by the patient.
The main aim of the drug directorate is to guarantee safety, quality, efficacy
and availability of the drugs at affordable prices in the local market.
The drug directorate is responsible for registering and pricing the drug
(according to approved laws, regulations and guidelines published in the
official gazette and on the JFDA website).
The drug directorate is responsible for the clinical studies and monitors
them through all stages according to the clinical studies law no. 2 for the year
2011, which is a permanent law for the provisional law no. 67 for the year
2001.
The Exporting and the Importing Departments also fall under the
jurisdiction of the Drug Directorate.
It includes the Monitoring and Inspection department that follows up the
inspection of all pharmaceutical institutions. It also includes the Narcotics
Department which deals with monitoring narcotics and precursors, and the
issuance of licenses for concerned parties.
Finally, the drug directorate is responsible for the rational use of drugs and for
issuing the import, export and release statistics to all the drugs in Jordan.
There are many working committees in the drug directorate (according to the
drug &pharmacy law and the clinical studies law no. 2 for the year 2011).
Their main responsibility is to take the right decision concerning different
issues.
The most important ones are:1- The Higher committee for Drug and Pharmacy
2- Technical committee for the registration of new drugs (originators)
3- Clinical Studies Committee
4- Technical committee for studying the generic drugs
5- Pricing committee
1
6- Manufacturing sites accreditation committee
7- Bioequivalence studies committee
8- Re registration committee (2002-2003)
9- Re registration committee (2004-2005)
10- Infant milk formula, special formula and food supplement (related to
them)
11- Sera and vaccines committee
12- Pharmaceutical
committee
preparations
containing
vitamins
and
minerals
13- Medicinal plants and natural extracts committee
14- Quality Control on Drugs committee
15- Classification committee for products applied for registration
16- Committee for evaluation of validation studies for method of analysis
applied for registration of products in Quality Control Laboratory
17- Committee of studying samples specification for packaging and filling
materials
18- Post approval changes evaluation committee
19- Committee of health hazards
20- Objections evaluation committee
Departments of the Drug Directorate
1) Registration Division :
Responsible for the process of drugs registration and release of the
following: composition of infant formula, special formula and supplementary
foods for them, medicinal plants & herbal products, pharmaceutical
preparations containing vitamins and minerals, through implementation of the
drug and pharmacy law& the published regulations, to ensure the safety,
quality and efficacy of these products, whether locally manufactured or
imported, and their follow-up after registration.
2
2) Pricing Division :
Pricing department was established in 21/5/2002 after issuing the Drug
& Pharmacy law ( temporary law no.80 year 2001) ,accordingly the Drugs
Pricing committee was formed from persons of specialty whose role is to
implement the Criteria & Standards related to drugs pricing ,re pricing and
objections to pricing decisions issued in the official gazette no.4641 dated
29/1/2004 and updated on 15/3/2012 , from that date onwards, the pricing
department was keen to implement these criteria which revealed a transparent
,clear and standardized pricing procedures.
3) Inspection& Monitoring Department
Responsible for the inspection of all pharmaceutical institutions
(pharmacies, drug stores, hospitals and manufacturing facilities….etc.).
Issuing legal actions against violations.
4) Import & Export Division:
 Approval of the importation of drugs, sera & vaccines, infant formula &
infant milk for the local market & tenders.
 Approval of the importation of dietary supplements, vitamins, minerals
& natural products.
 Approval of the importation of raw materials for local manufacturers.
 Approval of medicinal products, medical devices, antiseptics,
disinfectants.
 Approval of the importation of drugs & dietary supplements delivered
by mail for personal use.
 Approval of the importation of radio pharmaceuticals.
 Approval of the importation of culture media & IVF media.
 Follow up the export procedures related to exported drugs and related
materials according to article 3-b of Drug &Pharmacy law.
 Facilitate and handle all correspondences with the Jordanian
pharmaceutical industry.
 Issue annual statistics for imported medicines.
5) Narcotic, Psychotropic Substances and precursors Control Department
(NPPCD)
This department is the responsible authority on the licit trade control of
narcotic, psychotropic substances and controlled chemical precursors in Jordan
to ensure the availability of these substances for medical & scientific purposes
and prevention of its diversion from licit International Trade into illicit
Channels.
3
The control of these substances based on the provisions of the
international conventions and Jordan laws acts and regulations. The control
system is classified into the International control system which includes import
& export/system, reporting system (annual, quarterly statistical reports) the
assessment of annual medical & scientific requirements, the national control
system as licensing/system for physicians, pharmacists and scientific
institutions, distribution control system, reporting system ,recording system and
the inspection system to ensure the licit use and to monitor the application of
control measures required by the laws and regulations.
6) Clinical Studies Division :
Clinical studies division follows up clinical studies and monitors them
through all stages and this includes:
Receiving and evaluating all clinical studies protocols carried in Jordan.
Supervising and following up the clinical studies decisions.
Inspecting all the licensed institutions, centers (CROs), and related parties.
Holding workshops and submitting presentations to the medical services
providers sector.
Following-up the latest regulations, by contacting the International
Authorities.
It is highly important to mention that Jordan has a permanent law for clinical
studies, which is: Clinical studies law no. 2 for the year 2011 (which is an
amended copy of the provisional law no. 67 for the year 2001) that regulates
all the clinical studies conducted in Jordan.
7) Information Department :
This department was established by JFDA in October 2012 in order to
supervise all the statistics, action plan, departments' achievements, Sops,
job description and all the information related to the drug directorate. Its
main duties are :
- Supervises the electronic link with the departments to collect their target
achievements and release related statistics.
- Supervises the establishment of a database, to archive all the SOPs, job
descriptions and strategic & action plans of the directorate.
- Supervises the record keeping of the statistics issued by the departments of
4
Export & Import and Laboratory release.
- Relays emails to their relative department(s).
- Follow up the strategic stock for drugstores and local manufacturers.
8) Rational Drug Use Division (RDU) :
- Spreads the concept of rational use of drugs and issuing the Jordan National
Drug Formulary.
- Organizing and preparing for the meetings of the technical and national
committees that approve the Rational Drug List.
- Follow up issuing the updated rational drug List and posting it on the JFDA
website.
- Supervises META and GGM projects by organizing continuous meetings of
the committees and drafting the documents.
Organizing and arranging GGM and META workshops.
5