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Clinical Trials

 
A.    Approval of Clinical Trials in Lebanon

This section has been developed for individuals and organizations involved in health-related research with human participants. In particular, this document is intended to provide guidance to design and carry out health research studies to provide guidance on the requirements of the Lebanese Ministry of Public Health to approve a clinical trial in Lebanon.
 

B.    Authorization of Institutional Review Boards (IRBs)/Research Ethics Commitees (RECs)

This section has been developed to give guidance to hospitals and universities who have their own IRBs/RECs on the requirements needed by the Lebanese Ministry of Public Health to be officially authorized to be allowed to review and oversee the ethical aspects of research that involve human subjects. Hospitals and centers who do not have their own IRBs/RECs are allowed to be affiliated with authorized IRBs/RECs per the requirements of the Ministry.
 
List of Authorized IRBs
تؤكد وزارة الصحة العامة على جميع المستشفيات و المراكز التي ترغب باجراء دراسات سريرية و ابحاث تستهدف الانسان بضرورة الالتزام بالقرار رقم 141/1 تاريخ 27 كانون الثاني 2016  لجهة التقدم بطلب لوزارة الصحة العامة للاعتراف رسمياً بلجنة اخلاقيات الابحاث  Institutional Review Board (IRB)التابعة لها او التعاقد مع مستشفى او مركز  لديه  IRB معترف بها رسمياً من الوزارة.
و تود وزارة الصحة العامة التذكير بان المهلة المعطاة لتقديم المستندات المطلوبة تنتهي في 27 كانون الثاني 2017, و بناءاً عليه لن توافق الوزارة على اي دراسة سريرية خارج هذا الاطار بعد هذا التاريخ.
 
تجدون ربطاً لائحة الجامعات والمستشفيات التي قدمت طلبات للإعتراف بلجان الأخلاقيات  للتجارب السريرية التابعة لها والطلبات التي تمت دراستها و الطلبات التي تمت الموافقة عليها.
 
 
 
C.     Exportation of Biological Samples as part of clinical trials

This section is developed to give guidance to researchers and sponsors who wish to export biological samples (blood, urine, etc) to be tested outside the country as part of clinical trials protocols on the requirements needed to obtain the approval from the ministry.
 

D.     Lebanon Clinical Trials Registry (LBCTR)

The Lebanese Clinical Trials Registry (LBCTR) is an online register of clinical trials being undertaken in Lebanon. The LBCTR will include trials that target humans; from the full spectrum of therapeutic areas of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies and complementary therapies.

The LBCTR will allow registration for interventional as well as observational studies.
  • The MOPH is the owner and the sole manager of the LBCTR.
  • All details of trials registered on the LBCTR will be made publicly available.
  • The registration of Interventional studies will be mandatory and observational studies will be voluntary.
  • The registration of studies is free of charge.
  • The responsibility for registration lies with the sponsor.
  • The sponsor is defined as:  an individual, company or institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.
  • It is the sponsor's responsibility to ensure that the information submitted is accurate and up-to-date.
LBCTR PUBLIC & APPLICANT USER GUIDE
 
Go to LBCTR website
 
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ATC Name B/G Ingredients Dosage Form Price
G03AB03 MICROGYNON '30' B Ethinylestradiol - 0.03mg, Levonorgestrel - 0.15mg Tablet, sugar coated 145,135 L.L
M01AB05 CATAFLAM B Diclofenac potassium - 50mg 50mg Tablet, sugar coated 262,049 L.L
N06AA02 TOFRANIL 10 B Imipramine HCl - 10mg 10mg Tablet, sugar coated 579,772 L.L
N06AA02 TOFRANIL 25 B Imipramine HCl - 25mg 25mg Tablet, sugar coated 1,002,123 L.L
N06AA21 LUDIOMIL B Maprotiline - 10mg 10mg Tablet, sugar coated 867,738 L.L
N06AA21 MEFIDIOMIL B Maprotiline - 25mg 25mg Tablet, sugar coated 909,973 L.L
N06AA21 MEFIDIOMIL B Maprotiline - 75mg 75mg Tablet, sugar coated 958,608 L.L
A03BB01 BUSCOPAN B Butylscopolamine bromide - 10mg 10mg Tablet, sugar coated 692,079 L.L
A03BB01 BUSCOPAN B Butylscopolamine bromide - 10mg 10mg Tablet, sugar coated 291,614 L.L
A03CA02 LIBRAX DRAGEES B Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet, sugar coated 435,405 L.L
A03CA02 BIPAX G Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet, sugar coated 363,477 L.L
A06AB02 DULCOLAX B Bisacodyl - 5mg 5mg Tablet, sugar coated 520,067 L.L
A06AB02 DULCOLAX B Bisacodyl - 5mg 5mg Tablet, sugar coated 219,046 L.L
B03AD03 GYNO-TARDYFERON B Folic acid - 0.35mg, Ferrous (sulfate) - 80mg Tablet, sugar coated, slow release 682,672 L.L
C04AD03 PENTOXIFYLLINE SR G Pentoxifylline - 1160 400mg Tablet, sustained release 1,478,227 L.L
M01AB05 DICLO-DENK 100 RETARD G Diclofenac sodium - 100mg 100mg Tablet, sustained release 1,756,402 L.L
A12BA01 EURO-K G Potassium chloride - 1.5g 1.5g Tablet, sustained release 573,821 L.L
C08CA05 NIFELAT R G Nifedipine - 20mg 20mg Tablet, sustained release 388,370 L.L
C03BA11 FLUDEX B Indapamide - 1.5mg 1.5mg Tablet, sustained release 517,379 L.L
G02AD02 PROPESS B Dinoprostone - 10mg 10mg Vaginal delivery system 5,838,996 L.L
N01AB06 ISOFLURANE HIKMA G Isoflurane - Volatil liquid 1,583,046 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,240,367 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,034,759 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 795,555 L.L
V07AB01 EAU POUR PREPARATIONS INJECTABLES RENAUDIN G Water for injection - Water for injection, irrigation 266,081 L.L
V07AB01 EAU POUR PREPARATION INJ. G Water for injection - Water for injection, irrigation 3,385,139 L.L
V07AB01 WATER FOR INJECTION/ DEMO G Water for injection - Water for injection, irrigation 1,339,811 L.L
V07AB01 WATER FOR INJECTION/ DEMO G Water for injection - Water for injection, irrigation 1,103,295 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 188,772 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 203,481 L.L
    ...
    177
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