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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
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 189,262 L.L
C08CA04 NICARDIPINE ARROW G Nicardipine chlorhydrate - 10mg/10ml 10mg/10ml Injectable solution 2,590,928 L.L
C09DX01 VIOSTAN AM PLUS 160/5/25 G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,196,020 L.L
D05AA VASELINE ICHTYOLEE G Ichthyamol - 10% 10% Ointment 103,668 L.L
J01DH51 IMILASTIN G Imipenem - 500mg, Cilastatin - 500mg Injectable powder for solution 5,869,189 L.L
J05AF10 ENTRILIV G Entecavir - 0.5mg 0.5mg Tablet, film coated 19,165,898 L.L
M01AB05 OLFEN 75MG G Diclofenac sodium - 75mg 75mg Injectable solution 334,617 L.L
N01AH06 REMIFENTANIL MEDIS G Remifentanil (HCl) - 1mg 1mg Injectable powder 1,101,951 L.L
N03AX12 PMS-GABAPENTIN G Gabapentin - 400mg 400mg Capsule 1,071,042 L.L
N05BA12 ALPROX G Alprazolam - 0.5mg 0.5mg Tablet 383,955 L.L
R05X COLDIN-H G Paracetamol - 300mg, Mepyramine maleate - 15mg, Noscapine - 10mg Capsule 386,515 L.L
V03AF03 CALCIUMFOLINAT EBEWE G Calcium folinate - 100mg/10ml 100mg/10ml Injectable solution 1,289,872 L.L
A03FA03 FARCOTILIUM G Domperidone - 5mg/5ml 5mg/5ml Suspension 115,570 L.L
A10BB12 AMEPRIDE G Glimepiride - 4mg 4mg Tablet 215,015 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C08CA04 NICARDIPINE MEDIS G Nicardipine chlorhydrate - 10mg/10ml 10mg/10ml Injectable solution 1,295,464 L.L
D05AX52 BETA-CAL G Calcipotriol (monohydrate) - 50mcg/g, Betamethasone (dipropionate) - 0.5mg/g Ointment 1,574,983 L.L
G03DB08 DIENOSIS G Dienogest - 2mg 2mg Tablet 2,822,069 L.L
J01AA07 TETRACYCLINE G Tetracycline HCl - 250mg 250mg Capsule 3,906,998 L.L
J01DH51 IMIPENEM-CILASTATIN LABATEC G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable powder for solution 8,922,845 L.L
J05AF10 HEPCAVIR 0.5 G Entecavir monohydrate - 0.5mg 0.5mg Tablet, film coated 18,998,515 L.L
L01DC01 BLEO-CELL G Bleomycin (sulfate) - 15mg 15mg Injectable powder for solution 3,054,554 L.L
M01AB05 VOLDEN G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 422,351 L.L
N03AX12 GABATREX G Gabapentin - 100mg 100mg Capsule 292,958 L.L
N05BA12 PAZOLAM G Alprazolam - 0.5mg 0.5mg Tablet 563,070 L.L
P02CA03 ALBENDA G Albendazole - 100mg/5ml 400mg/20ml Suspension 129,009 L.L
R06AA02 DIPHENIST G Diphenhydramine HCl - 50mg/ml 50mg/ml Injectable solution 6,977,230 L.L
V03AF03 EUROFOLIC G Folic acid as Calcium Folinate Hydrate - 100mg/10ml 10mg/ml Injectable solution 5,872,592 L.L
A03FA03 MOTIDOL ODT G Domperidone - 10mg 10mg Tablet, orodispersible 259,810 L.L
A10BB12 DIAMERIL G Glimepiride - 4mg 4mg Tablet 322,522 L.L
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