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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
A11DB NEUROBION B Vitamin B12 - 1000mcg, Vitamin B6 - 100mg, Vitamin B1 - 100mg Injectable solution 545,600 L.L
J01DD04 ROCEPHIN IV B Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 757,927 L.L
J01XA02 TARGOCID B Teicoplanin - 400mg 400mg Injectable lyophilised powder for solution+diluent 1,331,748 L.L
M01BX DORIXINA B1B6B12 B Lysine clonixinate - 125mg, Vitamin B1 - 50mg, Vitamin B6 - 30mg, Vitamin B12 - 50mcg Tablet, film coated 804,962 L.L
N05AH03 ZYPREXA B Olanzapine - 5mg 5mg Tablet 1,197,364 L.L
N06BA04 RITALIN B Methylphenidate HCl - 10mg 10mg Tablet 376,276 L.L
S01BC04 EDOLFENE B Flurbiprofen sodium - 0.03% 0.03% Drops solution 388,370 L.L
A02BC05 NEXIUM B Esomeprazole sodium - 40mg 40mg Injectable powder for solution 5,254,424 L.L
A11DB NEUROBION B Vitamin B12 - 1000mcg, Vitamin B6 - 100mg, Vitamin B1 - 100mg Injectable solution 287,582 L.L
C09DA03 CO-DIOVAN B Valsartan - 80mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 602,041 L.L
J01DD04 ROCEPHIN IM B Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 731,050 L.L
M02AA AIRTAL DIFUCREM 1.5% B Aceclofenac - 1.5g/100g 1.5% Cream 536,193 L.L
N05AH03 ZYPREXA B Olanzapine - 5mg 5mg Tablet 1,197,364 L.L
N06BA04 CONCERTA B Methylphenidate HCl - 27mg 27mg Tablet, extended release 4,393,021 L.L
R03BA05 FLIXOTIDE EVOHALER B Fluticasone propionate - 250mcg/actutaion 250mcg/actutaion Inhalation suspension 1,484,946 L.L
J01XA02 TARGOCID B Teicoplanin - 200mg 200mg Injectable lyophilised powder for solution+diluent 714,924 L.L
N06BA04 CONCERTA B Methylphenidate HCl - 36mg 36mg Tablet, extended release 4,393,021 L.L
R03BA05 FLIXOTIDE EVOHALER B Fluticasone propionate - 125mcg/actuation 125mcg/actuation Inhalation suspension 794,211 L.L
L01EX08 LENVIMA B Lenvatinib - 10mg 10mg Capsule, hard L.L
A11DB NEUROBION B Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet, coated 364,181 L.L
C09DA03 CO-DIOVAN B Valsartan - 160mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 846,621 L.L
C10AB05 LIPANTHYL 200 M B Fenofibrate - 200mg 200mg Capsule 1,072,878 L.L
G04CB02 AVODART B Dutasteride - 0.5mg 0.5mg Capsule 2,660,787 L.L
M02AA10 FASTUM B Ketoprofen - 2.5g/100g 2.5% Gel 177,387 L.L
N06BA04 CONCERTA B Methylphenidate HCl - 54mg 54mg Tablet, extended release 6,049,979 L.L
R03BA05 FLIXOTIDE EVOHALER B Fluticasone propionate - 50mcg/actuation 50mcg/actuation Inhalation suspension 671,921 L.L
L01EX08 LENVIMA B Lenvatinib - 4mg 4mg Capsule, hard L.L
A11DB NEUROBION B Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet, coated 550,975 L.L
C07AB03 TENORMIN B Atenolol - 100mg 100mg Tablet, film coated 279,519 L.L
M02AA10 FASTUM B Ketoprofen - 2.5g/100g 2.5% Gel 337,304 L.L
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