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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
D11AX18 LABDIC RELIEF G Diclofenac sodium - 1%w/w, Methyl salicylate - 8%w/w, Menthol - 2%w/w Gel 263,393 L.L
C07AG01 LABETALOL HYDROCHLORIDE INJECTION G Labetalol HCl - 100mg/20ml 100mg/20ml Injectable solution 2,955,110 L.L
R06AX29 LABIXTEN B Bilastine - 20mg 20mg Tablet 584,571 L.L
R06AX29 LABIXTEN B Bilastine - 2.5mg/ml 2.5mg/ml Solution 463,626 L.L
C09CA01 LACINE 50 G Losartan potassium - 50mg 50mg Tablet, film coated 671,921 L.L
N03AX18 LACOSAMIDE/GENEPHARM G Lacosamide - 50mg 50mg Tablet 614,136 L.L
N03AX18 LACOSAMIDE/GENEPHARM G Lacosamide - 100mg 100mg Tablet 4,856,647 L.L
N03AX18 LACOSAMIDE/GENEPHARM G Lacosamide - 200mg 200mg Tablet 8,284,105 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 147,095 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 218,681 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.02g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 239,275 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 234,862 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 268,908 L.L
B05BB01 LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 158,587 L.L
B05BB01 LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 216,046 L.L
B05BB01 LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 232,134 L.L
J01MA02 LADININ G Ciprofloxacine (HCl) - 500mg 500mg Tablet, film coated 541,863 L.L
J01MA02 LADININ G Ciprofloxacine (lactate) - 200mg/100ml 200mg/100ml Injectable solution 812,795 L.L
N03AX09 LAMICTAL B Lamotrigine - 100mg 100mg Tablet 2,646,122 L.L
N03AX09 LAMICTAL B Lamotrigine - 25mg 25mg Tablet 1,050,520 L.L
N03AX09 LAMICTAL B Lamotrigine - 50mg 50mg Tablet 1,693,055 L.L
N03AX09 LAMICTAL LIQUI-TABS B Lamotrigine - 5mg 5mg Tablet 348,522 L.L
D01AE15 LAMIFEN G Terbinafine HCl - 1% 1% Cream 321,178 L.L
D01BA02 LAMIFEN G Terbinafine HCl - 250mg 250mg Tablet 245,923 L.L
D01AE15 LAMINOX G Terbinafine HCl - 10mg/g 10mg/g Cream 453,067 L.L
D01BA02 LAMINOX G Terbinafine HCl - 250mg 250mg Tablet 725,675 L.L
D01AE15 LAMISIL B Terbinafine HCl - 10mg/g 1% Cream 616,824 L.L
D01AE15 LAMISIL B Terbinafine HCl - 10mg/g 1% Cream 616,824 L.L
D01AE15 LAMISIL B Terbinafine HCl - 10mg/ml 1% Solution 506,629 L.L
D01BA02 LAMISIL B Terbinafine HCl - 250mg 250mg Tablet, scored 813,025 L.L
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