Hotline for Health Services for Displaced Lebanese 1787
Hotline for the Patient Admission to Hospitals 01/832700
COVID-19 Vaccine Registration Form covax.moph.gov.lb
MoPH Hotline 1214
Are you a new member? Sign up now
 
Let us help you
Read about the latest topics.

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
 
    1
ATC Name B/G Ingredients Dosage Form Price
A05AA04 OCALIVA B Obeticholic acid - 10mg 10mg Tablet, film coated 224,503,943 L.L
A05AA04 OCALIVA B Obeticholic acid - 5mg 5mg Tablet, film coated 224,503,943 L.L
L04AA36 OCREVUS BioTech Ocrelizumab - 300mg/10ml 300mg/10ml Injectable concentrate for solution 547,517,314 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 2.5g/50ml Injectable solution 19,540,934 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution 37,672,334 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 10g/200ml Injectable solution 67,853,624 L.L
J06BA02 OCTAGAM 10% BioHuman Human normal immunoglobulin G - 10% 5g/50ml Injectable solution 37,672,334 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 250IU 250IU Injectable lyophilised powder for solution+diluent 13,247,110 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 500IU 500IU Injectable lyophilised powder for solution+diluent 26,495,478 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 1,000IU 1,000IU Injectable lyophilised powder for solution+diluent 46,817,511 L.L
B02BD04 OCTANINE F BioHuman Plasma coagulation factor IX, human - 500IU 500IU Injectable freeze dried powder + diluent 31,425,075 L.L
B02BD01 OCTAPLEX BioHuman Prothrombin complex, human (PPSB) - 500IU 500IU Injectable powder for solution+diluent 35,672,956 L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 880,217 L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 952,784 L.L
G03CA03 OESTRACLIN G Estradiol - 0.6mg/g 0.6mg/g Gel 448,843 L.L
G03CA03 OESTRODOSE B Estradiol (17 bêta estradiol anhydre) - 0.06% 0.06% Gel 642,357 L.L
L01EX09 OFEV B Nintedanib - 150mg 150mg Capsule, soft L.L
L01EX09 OFEV B Nintedanib - 100mg 100mg Capsule, soft 108,775,087 L.L
L01EX09 OFEV B Nintedanib - 150mg 150mg Capsule, soft 227,340,482 L.L
J01MA01 OFLACIN G Ofloxacin - 200mg 200mg Tablet, film-scored 602,041 L.L
S02AA16 OFLOMED G Ofloxacin - 3mg/ml 3mg/ml Drops solution 317,403 L.L
J01MA01 OFLOMED G Ofloxacin - 200mg 200mg Tablet, film-scored 601,530 L.L
S01AE01 OFLOX B Ofloxacin - 3mg/ml 0.3% Drops solution 366,869 L.L
S01AE01 OFLOX B Ofloxacin - 0.3% 0.3% Drops solution 366,869 L.L
L01FD01 OGIVRI BioTech Trastuzumab - 440mg 440mg Injectable lyophilised powder 80,027,615 L.L
N05AH03 OLANZAMED G Olanzapine - 5mg 5mg Tablet 665,522 L.L
N05AH03 OLANZAMED G Olanzapine - 20mg 20mg Tablet 3,941,938 L.L
N05AH03 OLANZAMED G Olanzapine - 10mg 10mg Tablet 902,294 L.L
N05AH03 OLANZAPINE ARROW G Olanzapine - 5mg 5mg Tablet 670,577 L.L
N05AH03 OLANZAPINE ARROW G Olanzapine - 10mg 10mg Tablet 822,432 L.L
    1
Sitemap
© Copyrights reserved to Ministry of Public Health 2025