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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
D08AX01 EAU OXYGENEE 10/120 G Hydrogen peroxide - 10V 10V Solution 119,026 L.L
V07AB01 EAU POUR PREPARATION INJ. G Water for injection - Water for injection, irrigation 3,385,139 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,240,367 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,034,759 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 795,555 L.L
V07AB01 EAU POUR PREPARATIONS INJECTABLES RENAUDIN G Water for injection - Water for injection, irrigation 266,081 L.L
R06AX22 EBASTEL B Ebastine - 10mg 10mg Tablet, film coated 722,987 L.L
R06AX22 EBASTINE ARROW G Ebastine - 10mg 10mg Tablet, coated 524,099 L.L
L01CA04 EBERELBIN G Vinorelbine (tartrate) - 50mg/5ml 50mg/5ml Injectable concentrated solution 6,834,783 L.L
L01CD01 EBETAXEL G Paclitaxel - 30mg/5ml 30mg/5ml Injectable concentrated solution 2,983,330 L.L
L01CD01 EBETAXEL G Paclitaxel - 150mg/25ml 150mg/25ml Injectable concentrated solution 15,457,059 L.L
L01BA01 EBETREXAT G Methotrexate - 50mg/5ml 50mg/5ml Injectable solution 1,507,821 L.L
L04AX03 EBETREXAT G Methotrexate - 5mg 5mg Tablet, scored 1,347,874 L.L
L04AX03 EBETREXAT G Methotrexate - 15mg/1.5ml 15mg/1.5ml Injectable solution 2,135,366 L.L
N06DX01 EBIXA B Memantine HCl - 10mg 10mg Tablet, film coated 2,143,429 L.L
N06DX01 EBIXA B Memantine - 20mg 20mg Tablet, film coated 4,004,651 L.L
J02AX06 ECALTA B Anidulafungin - 100mg 100mg Injectable concentrated powder for solution 16,977,343 L.L
G01AF05 ECOGYN G Econazole nitrate - 150mg 150mg Pessary 447,948 L.L
G01AF05 ECONAZ G Econazole nitrate - 150mg 150mg Ovule 415,951 L.L
D01AC03 ECONAZ G Econazole nitrate - 1% 1% Cream 307,164 L.L
G01AF05 ECOREX 150 G Econazole nitrate - 150mg 150mg Ovule 280,863 L.L
D07XB05 ECOZONE G Dexamethazone sodium phosphate - 0.1%, Econazole nitrate - 1% Cream 364,757 L.L
C09CA09 EDARBI B Azilsartan medoxomil - 40mg 40mg Tablet 1,846,440 L.L
C09CA09 EDARBI B Azilsartan medoxomil - 80mg 80mg Tablet 2,023,827 L.L
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 12.5mg Tablet, film coated 1,846,440 L.L
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 25mg Tablet, film coated 1,846,440 L.L
S01BC04 EDOLFENE B Flurbiprofen sodium - 0.03% 0.03% Drops solution 388,370 L.L
N06AX16 EFEXOR XR B Venlafaxine (HCl) - 75mg 75mg Capsule, sustained release 732,394 L.L
N06AX16 EFEXOR XR B Venlafaxine (HCl) - 150mg 150mg Capsule, sustained release 817,056 L.L
N02BE01 EFFERALGAN B Paracetamol - 500mg 500mg Tablet, effervescent scored 129,009 L.L
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