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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
B03BB01 FOLICIL G Folic acid - 5mg 5mg Tablet 584,571 L.L
C01BC04 FLECAINE B Flecainide acetate - 100mg 100mg Tablet, scored 878,873 L.L
C01BC04 FLECAINIDE ARROW LAB G Flecainide acetate - 100mg 100mg Tablet, scored 588,603 L.L
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 100mg 100mg Capsule, extended release 1,154,361 L.L
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 50mg 50mg Capsule, extended release 1,154,361 L.L
C03BA11 FLUDEX B Indapamide - 1.5mg 1.5mg Tablet, sustained release 517,379 L.L
C03CA01 FURESIX 40 G Furosemide - 40mg 40mg Tablet 166,381 L.L
C03CA01 FUROSETIC G Furosemide - 40mg 40mg Tablet, scored 121,586 L.L
C03CA01 FRURETIC G Furosemide - 20mg/2ml 20mg/2ml Injectable solution 2,600,655 L.L
C03CA01 FUROLIX G Furosemide - 20mg/2ml 20mg/2ml Injectable solution 1,612,611 L.L
C03CA01 FUROSEMIDE RENAUDIN G Furosemide (sodium) - 20mg/2ml 20mg/2ml Injectable solution 451,531 L.L
C03CA01 FUROSEMIDE SALF G Furosemide - 20mg/2ml 20mg/2ml Injectable solution 216,359 L.L
C03CA01 FUROSEMIDE RENAUDIN G Furosemide - 250mg/25ml 250mg/25ml Injectable solution 1,791,342 L.L
C03CA01 FUROSEMIDE S.A.L.F. G Furosemide - 250mg/25ml 250mg/25ml Injectable solution 919,188 L.L
C10AB05 FENOFIBRATE ARROW G Fenofibrate - 160mg 160mg Tablet 639,669 L.L
C10AB05 FENOSUP LIDOSE G Fenofibrate - 160mg 160mg Capsule 774,053 L.L
C10AB05 FINOFIB BENTA G Fenofibrate - 160mg 160mg Tablet, film coated 788,388 L.L
C10AB05 FINACOR G Fenofibrate micronised - 160mg 160mg Capsule 774,309 L.L
C10AB05 FENOGAL G Fenofibrate micronised - 200mg 200mg Capsule, micronized 392,402 L.L
D04AA13 FENISTIL B Dimethindene maleate - 1mg/g 1mg/g Gel 196,201 L.L
D06AX01 FUCIDIN B Fusidic acid - 20mg/g 2% Cream 259,362 L.L
D06AX01 FUCIDIN CREAM B Fusidic acid - 2% 2% Cream 491,846 L.L
D06AX01 FUCIDIN CREAM B Fusidic acid - 2% 2% Cream 345,368 L.L
D06AX01 FUTASOLE G Fusidic acid - 20mg/g 2% Cream 145,135 L.L
D06AX01 FUCIDIN B Fusidic acid (sodium salt) - 20mg/g 2% Ointment 259,362 L.L
D06AX01 FUCIDIN OINTMENT B Fusidic acid (sodium salt) - 2% 2% Ointment 491,846 L.L
D06AX01 FUCIDIN OINTMENT B Fusidic acid (sodium salt) - 2% 2% Ointment 345,368 L.L
D06AX01 FUCIKALT G Fusidic acid (sodium salt) - 2% 2% Ointment 209,895 L.L
D07AC04 FLUOCINOLONE ACETONIDE G Fluocinolone acetonide - 0.25mg/g 0.25mg/g Cream 296,925 L.L
D07CC01 FUCICORT B Fusidic acid - 20mg/g, Betamethasone (valerate) - 1mg/g Cream 376,276 L.L
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