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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
B05BB01 R-SOL G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 205,933 L.L
A02BC04 RABEC G Rabeprazole (sodium) - 10mg 10mg Tablet, film coated 212,327 L.L
A02BC04 RABEC G Rabeprazole (sodium) - 20mg 20mg Tablet, film coated 212,327 L.L
A02BC04 RABEZOL 20 G Rabeprazole sodium - 20mg 20mg Tablet, enteric coated 282,847 L.L
A02BC04 RABEZOL 20 G Rabeprazole sodium - 20mg 20mg Tablet, enteric coated 639,925 L.L
J06BB05 RABISHIELD-100 (RABIES HUMAN MONOCLONAL ANTIBODY rDNA) BioHuman Rabies, Human IgG1 Monoclonal Antibody - 100IU/2.5ml 100IU/2.5ml 8,455,824 L.L
J07BG01 RABIVAX-S (RABIES VACCINE INACTIVATED) BioTech Freeze dried inactivated purified rabies antigen (Pitman Moore PM3218 as virus strain) - Injectable freeze dried material 1,552,138 L.L
A07XA04 RACECADOTRIL ARROW G Racecadotril - 100mg 100mg Capsule 583,228 L.L
A07XA04 RACECADOTRIL BGR G Racecadotril - 100mg 100mg Capsule 575,165 L.L
A07XA04 RACECADOTRIL BIOGARAN CONSEIL G Racecadotril - 100mg 100mg Capsule 287,582 L.L
H02AB02 RADOLINE G Dexamethasone sodium phosphate - 8mg/2ml 8mg/2ml Injectable solution 3,711,565 L.L
G03XC01 RALOXIFENE ARROW G Raloxifene HCl - 60mg 60mg Tablet, coated 1,425,817 L.L
P01AB01 RAMAZOL G Metronidazole - 500mg 500mg Tablet 216,359 L.L
A02BC04 RAMEP G Rabeprazole (sodium) - 10mg 10mg Tablet, gastroresistant 752,891 L.L
A02BC04 RAMEP G Rabeprazole (sodium) - 20mg 20mg Tablet, gastroresistant 472,429 L.L
C09AA05 RAMIPRIL-REMEDICA G Ramipril - 5mg 5mg Tablet 623,543 L.L
C09AA05 RAMIPRIL-REMEDICA G Ramipril - 10mg 10mg Tablet 896,343 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 2.5mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 5mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 10mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 10mg, Amlodipine - 10mg Capsule, hard 1,358,625 L.L
C01EB18 RANEXA B Ranolazine - 375mg 375mg Tablet, prolonged release 3,985,837 L.L
C01EB18 RANEXA B Ranolazine - 500mg 500mg Tablet, prolonged release 3,985,837 L.L
C01EB18 RANEXA B Ranolazine - 750mg 750mg Tablet, prolonged release 3,985,837 L.L
L04AA10 RAPAMUNE B Sirolimus - 1mg 1mg Tablet L.L
L04AA10 RAPAMUNE B Sirolimus - 1mg 1mg Tablet 12,907,489 L.L
R05DB13 RAPICOD G Butamirate citrate - 0.15% 0.15% Syrup 296,989 L.L
M01AB05 RAPIDUS G Diclofenac potassium - 50mg 50mg Tablet, coated 287,582 L.L
N04BD02 RASAGILINE BIOGARAN G Rasagiline - 1mg 1mg Tablet 5,214,109 L.L
G04BE08 RAVANA G Tadalafil - 20mg 20mg Tablet 500,421 L.L
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