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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
J02AC01 FLOCAZOLE G Fluconazole - 150mg 150mg Capsule 172,012 L.L
L04AX04 REVLIMID B Lenalidomide - 10mg 10mg Capsule 110,200,672 L.L
A07XA04 RACECADOTRIL BIOGARAN CONSEIL G Racecadotril - 100mg 100mg Capsule 287,582 L.L
A11CC05 D-VITAL G Vitamin D3 - 10,000IU 10,000IU Capsule 561,342 L.L
J02AC01 FUNGIMID 150 G Fluconazole - 150mg 150mg Capsule 172,012 L.L
L04AX04 LEDOBOOK 10 G Lenalidomide - 10mg 10mg Capsule 62,230,245 L.L
A07XA04 RACECADOTRIL BGR G Racecadotril - 100mg 100mg Capsule 575,165 L.L
A11CC05 BENTA D 10.000 G Vitamin D3 - 10,000IU 10,000IU Capsule 895,895 L.L
C10AX06 VASCEPA B Eicosapentaenoic acid (Ethyl ester) - 1g 1g Capsule 21,464,912 L.L
J02AC01 ORAMAX G Fluconazole - 150mg 150mg Capsule 170,668 L.L
L04AX04 SOTIRA G Lenalidomide - 10mg 10mg Capsule 72,248,183 L.L
N07CA02 CINARIN G Cinnarizine - 75mg 75mg Capsule 490,183 L.L
A07XA04 RACECADOTRIL ARROW G Racecadotril - 100mg 100mg Capsule 583,228 L.L
A11CC05 MAXI-D 10.000 G Vitamin D3 - 10,000IU 10,000IU Capsule 895,895 L.L
N07CA02 CINNARIZINE G Cinnarizine - 75mg 75mg Capsule 386,515 L.L
L04AX04 LIDAMID 10 G Lenalidomide - 10mg 10mg Capsule 75,120,146 L.L
A11CC05 ONE BIG-D 10.000 G Vitamin D3 - 10,000IU 10,000IU Capsule 895,895 L.L
J02AC01 FLUCOKEY G Fluconazole - 150mg 150mg Capsule 81,974 L.L
L04AX04 LENALIDOMIDE OHRE PHARMA G Lenalidomide - 10mg 10mg Capsule 30,336,491 L.L
A08AB01 XENICAL B Orlistat - 120mg 120mg Capsule 4,036,903 L.L
A11CC05 ALTO D 10.000 G Vitamin D3 - 10,000IU 10,000IU Capsule 895,895 L.L
L04AX04 LENALIDOMIDE NEAPOLIS G Lenalidomide - 10mg 10mg Capsule 72,248,183 L.L
A08AB01 UNI-CAL G Orlistat - 120mg 120mg Capsule 1,174,518 L.L
A11CC05 VIT-X-FORTE G Vitamin D3 - 10,000IU 10,000IU Capsule 895,895 L.L
J02AC01 FLUNAZOL G Fluconazole - 150mg 150mg Capsule 149,742 L.L
A08AB01 ONLEFIT G Orlistat - 120mg 120mg Capsule 1,537,356 L.L
A11CC05 ALTUM-D3 G Vitamin D3 - 10,000IU 10,000IU Capsule 561,342 L.L
L04AX04 REVLIMID B Lenalidomide - 15mg 15mg Capsule 116,241,703 L.L
A08AB01 ORLISTAT-SIGMA G Orlistat - 120mg 120mg Capsule 847,965 L.L
A11CC05 SUN-D3 G Vitamin D3 - 10,000IU 10,000IU Capsule 935,570 L.L
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