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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
L01FF01 OPDIVO BioTech Nivolumab - 100mg/10ml 100mg/10ml Injectable solution L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 105mg/0.7ml 105mg/0.7ml Injectable solution 577,741,643 L.L
L04AA36 OCREVUS BioTech Ocrelizumab - 300mg/10ml 300mg/10ml Injectable concentrate for solution 547,517,314 L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution L.L
L01FG02 CYRAMZA BioTech Ramucirumab - 500mg/50ml 500mg/50ml Injectable solution L.L
A10AB01 ACTRAPID BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 752,552 L.L
L04AC05 STELARA BioTech Ustekinumab - 90mg 90mg Injectable solution L.L
A10AB01 ACTRAPID BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 752,552 L.L
B02BD02 XYNTHA BioTech Moroctocog alfa - 500IU 500IU Injectable lyophilised powder for solution+diluent L.L
A10AB01 HUMULIN R U-100 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 701,486 L.L
L01FA01 MABIXEN 100 BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 22,183,393 L.L
A10AB01 JUSLINE R BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 401,809 L.L
L01FA01 MABIXEN 100 BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 11,091,696 L.L
L04AA52 KESIMPTA BioTech Ofatumumab - 20mg/0.4ml 20mg/0.4ml Injectable solution 96,542,598 L.L
L01FC01 DARZALEX BioTech Daratumumab - 400mg/20ml 400mg/20ml Injectable concentrate for solution L.L
A10AB04 HUMALOG KWIKPEN BioTech Insulin lispro - 100IU/ml 100IU/ml Injectable solution 3,950,897 L.L
L01FA01 MABTHERA BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrated solution 35,722,424 L.L
L04AB01 ALTEBREL BioTech Etanercept - 50mg/1ml 50mg/1ml Injectable solution 14,833,767 L.L
A10AB04 PROLOG BioTech Insulin lispro - 100U/ml 100U/ml Injectable solution 637,365 L.L
L01FA01 RITUXIREL BioTech Rituximab - 100mg 100mg/10ml Injectable concentrated solution 11,708,063 L.L
L04AB01 ENBREL BioTech Etanercept - 50mg 50mg Injectable solution 52,197,598 L.L
A10AB04 PROLOG BioTech Insulin lispro - 100U/ml 100U/ml Injectable solution 2,126,343 L.L
L01FA01 RIXATHON BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 27,354,833 L.L
L04AB01 ENBREL BioTech Etanercept - 50mg 50mg Injectable solution 52,197,598 L.L
A10AB04 PROLOG BioTech Insulin lispro - 100U/ml 100U/ml Injectable solution 883,480 L.L
L01FA01 RUXIENCE BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 13,157,756 L.L
L04AB01 ERELZI BioTech Etanercept - 50mg 50mg Injectable solution 56,780,638 L.L
A10AB04 HUMALOG BioTech Insulin lispro - 100IU/ml 100IU/ml Injectable suspension 1,988,887 L.L
L01FA01 TRUXIMA BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 31,060,158 L.L
L04AB01 ERELZI BioTech Etanercept - 50mg 50mg Injectable solution 39,269,439 L.L
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