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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
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 2,228,091 L.L
A10BD02 ORBIZIDE M FORTE G Metformin HCl - 500mg, Gliclazide - 80mg Tablet 771,750 L.L
B01AC04 CERUVIN G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 240,548 L.L
B05BB02 MIXTE SIMPLE (2) G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 207,894 L.L
C01BC04 FLECAINIDE ARROW LAB G Flecainide acetate - 100mg 100mg Tablet, scored 588,603 L.L
C08CA05 NIFELAT 30 LA G Nifedipine - 30mg 30mg Tablet, prolonged release 1,007,882 L.L
C09DX01 VIOSTAN AM PLUS 160/10/12.5 G Valsartan - 160mg, Amlodipine - 10mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,196,020 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 90,869 L.L
G03DA04 PROGEST 200 G Progesterone micronised - 200mg 200mg Capsule, soft gelatin 411,216 L.L
J01DH02 AROPEM G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 995,723 L.L
J05AF05 LAMIVUDINE ARROW G Lamivudine - 150mg 150mg Tablet, coated, scored 7,850,907 L.L
L01CE02 IRINOGEN G Irinotecan HCl - 100mg 100mg Injectable solution 5,239,642 L.L
L04AX07 MAROVAREX G Dimethyl Fumarate - 120mg 120mg Capsule, hard, gastro-resistant 9,838,676 L.L
M05BA07 PMS-RISEDRONATE G Risedronate sodium - 35mg 35mg Tablet 674,609 L.L
N03AX09 LAMOTRIGINE ARROW LAB G Lamotrigine - 25mg 25mg Tablet, dispersible/ chewable 556,351 L.L
N05AX12 JOSWE ARIPAL 5 G Aripiprazole - 5mg 5mg Tablet 1,389,533 L.L
R05CB06 SOLVAMUC SR G Ambroxol - 75mg 75mg Capsule 276,448 L.L
S03CA04 MYCICORT G Hydrocortisone acetate - 5mg, Neomycin sulfate - 5mg Drops suspension 166,381 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron - 4mg/2ml 4mg/2ml Injectable solution 978,317 L.L
B01AC04 CLODOR G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 1,148,025 L.L
B05BB02 SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 194,211 L.L
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 100mg 100mg Capsule, extended release 1,154,361 L.L
C08CA05 NIFELAT 60 LA G Nifedipine - 60mg 60mg Tablet, prolonged release 1,290,089 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 174,060 L.L
J01DH02 AROPEM G Meropenem - 1g 1g Injectable powder for solution 995,723 L.L
J05AF05 VICONDINE G Lamivudine - 150mg 150mg Tablet, film coated 3,573,725 L.L
L01CE02 IRINOTECAN GP PHARM G Irinotecan HCl trihydrate - 100mg/5ml 100mg/5ml Injectable concentrated solution 5,239,642 L.L
L04AX07 MAROVAREX G Dimethyl Fumarate - 240mg Capsule, hard, gastro-resistant 60,848,734 L.L
M05BA07 RISEDRONATE ARROW G Risedronate sodium - 35mg 35mg Tablet, film coated 671,921 L.L
N03AX09 LAMOTRIGINE BIOGARAN G Lamotrigine - 25mg 25mg Tablet, dispersible 595,322 L.L
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