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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
C01CA24 ADRENALINE RENAUDIN G Epinephrine (tartrate) - 1mg/ml 1mg Injectable solution 444,812 L.L
C01CA24 ADRENALINE SALF G Adrenaline - 1mg/ml 1mg/ml Injectable solution 220,390 L.L
C01CA24 ADRENALINE AGUETTANT G Adrenaline - 0.1mg/ml 0.1mg/ml Injectable solution 13,990,891 L.L
N01BB58 ARTINIBSA 4% WITH EPINEPHRINE 1/100000 B Articaine HCl - 4%, Epinephrine - 1/100.000 Injectable solution 1,968,729 L.L
N01BB58 ARTICAINE MEDIS ADRENALINE G Articaine HCl - 40mg/ml, Adrenaline - 0.07mg/ml Injectable solution 1,881,380 L.L
J06BA02 ARAGAM BioHuman Human normal immunoglobulin - 5g/100ml 5g/100ml Injectable solution 38,549,017 L.L
L04AB01 ALTEBREL BioTech Etanercept - 50mg/1ml 50mg/1ml Injectable solution L.L
A04AA05 ALOXI B Palonosetron HCl - 0.25mg/5ml 0.25mg/5ml Injectable solution 3,656,595 L.L
J01GB06 AMICINE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 1,749,683 L.L
J01GB06 AMIKACIN SULPHATE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 372,244 L.L
L03AB07 AVONEX BioTech Interferon beta-1a - 30mcg/0.5ml 30mcg/0.5ml Injectable solution 70,488,764 L.L
N05AX12 ABILIFY MAINTENA B Aripiprazole - 400mg 400mg Injectable powder for suspension, prolonged release+solvent 29,491,998 L.L
L01BC07 AZACITIDINE EVER PHARMA G Azacitidine - 100mg/100ml 25mg/ml Injectable powder for suspension 10,967,854 L.L
B02BD08 ARYOSEVEN RT BioTech Eptacog alfa - 1mg 1mg Injectable powder for solution+diluent 16,902,713 L.L
J01DD04 AXONE 1G IM G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution+diluent 438,093 L.L
J01DD04 AXONE 500MG IM G Ceftriaxone (sodium) - 500mg 500mg Injectable powder for solution+diluent 393,746 L.L
B02BD08 ARYOSEVEN RT BioTech Eptacog alfa - 1mg 1mg Injectable powder for solution+diluent L.L
J01DC02 AXETINE G Cefuroxime sodium - 750mg 750mg Injectable powder for solution 1,193,332 L.L
J01DC02 AXETINE G Cefuroxime sodium - 1.5g 1.5g Injectable powder for solution 2,273,782 L.L
J01DD04 AXONE G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution 4,053,029 L.L
L01XG01 ALVOCADE G Bortezomib - 3.5mg 3.5mg Injectable powder for solution 14,169,600 L.L
J01DH02 ARCHIFAR G Meropenem - 500mg 500mg Injectable powder for solution 6,443,725 L.L
J01DH02 AROPEM G Meropenem (trihydrate) - 0.5g 0.5g Injectable powder for solution 995,723 L.L
J01DH02 AROPEM G Meropenem - 0.5g 0.5g Injectable powder for solution 995,723 L.L
J01DH02 ARCHIFAR G Meropenem - 1g 1g Injectable powder for solution 6,443,725 L.L
J01DH02 AROPEM G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 995,723 L.L
J01DH02 AROPEM G Meropenem - 1g 1g Injectable powder for solution 995,723 L.L
J01CA01 AMPICILLINE PANPHARMA G Ampicillin (sodium) - 500mg 500mg Injectable powder for solution 1,944,540 L.L
J01CA01 AMPICILLINE PANPHARMA G Ampicillin (sodium) - 1g 1g Injectable powder for solution 2,857,009 L.L
J01CA04 AMOXICILLINE INJ. G Amoxicillin (sodium) - 1g 1g Injectable powder for solution 1,173,175 L.L
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