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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
A01AB09 MICOZOLE G Miconazole - 20mg/g 20mg/g Gel 104,820 L.L
A01AB09 MYCOHEAL G Miconazole nitrate - 20mg/g 20mg/g Gel 210,983 L.L
D01AC02 MICONAZ G Miconazole nitrate - 20mg/g 20mg/g Gel 427,470 L.L
L03AX16 MOZOBIL B Plerixafor - 20mg/ml 20mg/ml Injectable solution 413,801,327 L.L
A11CC05 MEGAVIT-D 25 G Vitamin D3 - 25000IU 25000IU Capsule 1,130,108 L.L
A11CC05 MEGAVIT-D 25 G Vitamin D3 - 25000IU 25000IU Capsule 2,147,588 L.L
P01AB01 METROLAG G Metronidazole - 250mg 250mg Tablet 130,353 L.L
P01AB01 METRONIDAZOLE G Metronidazole - 250mg 250mg Tablet 6,540,034 L.L
P01AB01 METRONIDAZOLE 250 G Metronidazole - 250mg 250mg Tablet 131,825 L.L
R05CB03 MUCOTAL ADULTE G Carbocysteine - 250mg/5ml 250mg/5ml Syrup 308,444 L.L
A02BB01 MISOFAR G Misoprostol - 25mcg 25mcg Tablet 1,855,846 L.L
N06AA21 MEFIDIOMIL B Maprotiline - 25mg 25mg Tablet, sugar coated 909,973 L.L
L04AX03 METOJECT G Methotrexate disodium - 25mg/0.5ml 25mg/0.5ml Injectable solution 2,582,865 L.L
L04AA42 MAYZENT B Siponimod - 2mg 2mg Tablet, film coated 124,258,444 L.L
C01DX12 MOLSIDOMINE BIOGARAN G Molsidomine - 2mg 2mg Tablet, scored 256,674 L.L
C01DX12 MOLSIDOMINE BIOGARAN G Molsidomine - 2mg 2mg Tablet, scored 713,580 L.L
D06AA04 MEPHICYCLINE DERMIQUE G Tetracycline HCl - 3% 3% Ointment 145,903 L.L
N01BB03 MEDICAINE 3% SANS VASOCONSTRICTEUR G Mepivacaine HCl - 3% 3% Injectable solution 954,128 L.L
J01DD15 MINOCET G Cefdinir - 300mg 300mg Capsule 1,407,003 L.L
C08DB01 MONO-TILDIEM LP/SR B Diltiazem HCl - 300mg 300mg Capsule, sustained release 658,483 L.L
N06AX11 MIRTA TAD G Mirtazapine - 30mg 30mg Tablet, film coated 1,138,235 L.L
R05CB06 MUKORAL G Ambroxol - 30mg 30mg Tablet 201,576 L.L
N02AA01 MST CONTINUS B Morphine sulfate - 30mg 30mg Tablet, film coated, prolonged release 2,289,908 L.L
G04BD06 MICTONORM XL B Propiverine HCl - 30mg 30mg Capsule, modified release 1,648,895 L.L
R05CB06 MUCOSOLVAN B Ambroxol HCl - 30mg/5ml 30mg/5ml Syrup 380,307 L.L
R05CB06 MUCOVIC FORTE G Ambroxol HCl - 30mg/5ml 30mg/5ml Solution, sugar free 293,086 L.L
R05CB06 MUCOVIC FORTE G Ambroxol HCl - 30mg/5ml 30mg/5ml Solution, sugar free 440,268 L.L
R05CB06 MUKORAL G Ambroxol HCl - 30mg/5ml 30mg/5ml Syrup 341,336 L.L
J01CR02 MOXICLAV FORTE G Amoxicillin (trihydrate) - 250mg/5ml, Clavulanic Acid (potassium) - 62.5mg/5ml 312.5mg/5ml Powder for suspension 298,333 L.L
M05BA07 MADRONATE G Risedronate sodium - 35mg 35mg Tablet, film coated 724,907 L.L
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