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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
L01XG01 BORTEZOMIB ACCORD G Bortezomib - 3.5mg 3.5mg Injectable powder for solution 13,007,658 L.L
L04AX04 LENALIDOMIDE OHRE PHARMA G Lenalidomide - 25mg 25mg Capsule 32,045,727 L.L
N05AX12 ATYPRAL G Aripiprazole - 15mg 15mg Tablet 712,237 L.L
N07CA02 CINARIN G Cinnarizine - 75mg 75mg Capsule 490,183 L.L
R05CB06 FLUIBRON G Ambroxol - 15mg/5ml 15mg/5ml Syrup 459,594 L.L
S02CA05 CETRAXAL PLUS G Ciprofloxacine HCl monohydrate - 3mg/ml, Fluocinolone acetonide - 0.25mg/ml Drops solution 795,555 L.L
A03FA03 FARCOTILIUM G Domperidone - 5mg/5ml 5mg/5ml Suspension 115,570 L.L
B05BB01 SERUFLEX RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 204,554 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:111.5 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C08CA01 LUSTRA G Amlodipine - 5mg 5mg Tablet 485,127 L.L
C09DB07 CANDAM G Candesartan cilexetil - 8mg, Amlodipine - 5mg Capsule, hard 1,376,095 L.L
D03AX RENEBO G ?-sitosterol - 0.25% w/w 0.25% w/w Ointment 456,906 L.L
J05AB11 VALACICLOVIR ARROW G Valaciclovir - 500mg 500mg Tablet, film coated, breakable 753,896 L.L
L01CD02 DOCETAXEL EBEWE G Docetaxel - 20mg/2ml 20mg/2ml Injectable solution 5,313,553 L.L
L01XG01 BORTEZOMIB GP PHARM G Bortezomib - 3.5mg 3.5mg Injectable powder for solution 13,007,658 L.L
L04AX04 LENALIDOMIDE SPC G Lenalidomide - 25mg 25mg Capsule, hard 87,161,381 L.L
N03AX09 LAMOTRIGINE ARROW LAB G Lamotrigine - 100mg 100mg Tablet, dispersible/ chewable 1,050,885 L.L
N05AX12 JOSWE ARIPAL 15 G Aripiprazole - 15mg 15mg Tablet 2,413,541 L.L
N07CA02 CINNARIZINE G Cinnarizine - 75mg 75mg Capsule 386,515 L.L
R05CB06 MUCUM G Ambroxol HCl - 15mg/5ml 15mg/5ml Syrup, sugar free, alcohol free 98,101 L.L
S02CA06 POLYDEXA G Dexamethasone sodium metasulfobenzoate - 1.000.000IU/100ml, Polymyxin B sulfate - 100mg/100ml, Neomycin sulfate - 650.000IU/100ml Drops solution 231,141 L.L
A03FA03 MOTIDOL ODT G Domperidone - 10mg 10mg Tablet, orodispersible 259,810 L.L
A10BB12 AMEPRIDE G Glimepiride - 4mg 4mg Tablet 215,015 L.L
B05BB01 SOLUFLEX RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 221,792 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS2 G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.5 mmol/l, Sodium acetate - Cl-:111 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C08CA01 TORANS G Amlodipine (besylate) - 5mg 5mg Tablet 518,339 L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 8mg, Amlodipine - 5mg Capsule, hard 1,368,032 L.L
J01DH02 ARCHIFAR G Meropenem - 500mg 500mg Injectable powder for solution 6,443,725 L.L
J05AB11 VALACICLOVIR ARROW G Valaciclovir - 500mg 500mg Tablet, film coated, breakable 2,889,261 L.L
L01CD02 DOCETAXEL GP PHARM G Docetaxel - 40mg/ml 20mg/0.5ml Injectable concentrated solution+diluent 4,567,721 L.L
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