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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
N03AX12 NEUROPLEX G Gabapentin - 300mg 300mg Capsule 1,107,326 L.L
N03AX12 GABATREX G Gabapentin - 300mg 300mg Capsule 1,585,734 L.L
N03AX12 APO-GABAPENTIN G Gabapentin - 300mg 300mg Capsule 2,527,768 L.L
N03AX12 VOLAR G Gabapentin - 300mg 300mg Capsule 1,100,607 L.L
L01XJ01 ERIVEDGE B Vismodegib - 150mg 150mg Capsule 465,368,012 L.L
N03AX12 GABAPENTINE ARROW GENERIQUES G Gabapentin - 300mg 300mg Capsule 1,342,499 L.L
J01DD15 OMNICEF 300 B Cefdinir - 300mg 300mg Capsule 2,238,842 L.L
J01DD15 OMNICEF B Cefdinir - 300mg 300mg Capsule 2,238,842 L.L
M09AX NUCLEO C.M.P. FORTE G UTP+UDP+UMP - 3mg, CMP - 5mg Capsule 448,843 L.L
N03AX12 GABAPENTINE ARROW GENERIQUES G Gabapentin - 300mg 300mg Capsule 1,342,499 L.L
J01DD15 SEFARIN G Cefdinir - 300mg 300mg Capsule 1,494,353 L.L
L01XK04 TALZENNA B Talazoparib - 1mg 1mg Capsule 401,512,167 L.L
N03AX12 GABANET 400 G Gabapentin - 400mg 400mg Capsule 1,607,236 L.L
J01DD15 MINOCET G Cefdinir - 300mg 300mg Capsule 1,407,003 L.L
L01XK04 TALZENNA B Talazoparib - 0.25mg 0.25mg Capsule 133,836,699 L.L
N03AX12 PMS-GABAPENTIN G Gabapentin - 400mg 400mg Capsule 1,071,042 L.L
J01DD15 XEVANEER G Cefdinir - 300mg 300mg Capsule 1,350,562 L.L
N03AX12 NEUROPLEX G Gabapentin - 400mg 400mg Capsule 1,290,089 L.L
N03AX12 GABATREX G Gabapentin - 400mg 400mg Capsule 1,846,440 L.L
L01XX05 CYTODROX G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 3,301,821 L.L
N03AX12 GABAPENTINE ARROW GENERIQUES G Gabapentin - 400mg 400mg Capsule 1,342,499 L.L
L01XX05 CUREAML G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 1,228,272 L.L
A02BC05 ESOCAP-UBSA G Esomeprazole - 20mg 20mg Capsule 511,940 L.L
N03AX12 GABAPENTINE ARROW GENERIQUES G Gabapentin - 400mg 400mg Capsule 1,342,499 L.L
N03AX12 GABATREX G Gabapentin - 100mg 100mg Capsule 292,958 L.L
A11EX BECOZYM FORTE B Nicotinamide - 50mg, Calcium Pantothenate - 25mg, Biotin - 0.15mg, Vitamin B12 - 10mcg, Vitamin B6 - 10mg, Vitamin B2 - 15mg, Vitamin B1 - 15mg Capsule 290,270 L.L
L01XX35 ANAGRELIDE BIOGARAN G Anagrelide - 0.5mg 0.5mg Capsule 15,754,068 L.L
A02BC05 ESOCAP-UBSA G Esomeprazole - 40mg 40mg Capsule 646,324 L.L
G03DA04 UTROGESTAN B Progesterone micronised natural - 100mg 100mg Capsule 525,442 L.L
G03DA04 UTROGESTAN B Progesterone micronised natural - 100mg 100mg Capsule 525,442 L.L
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