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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
 
ATC Name B/G Ingredients Dosage Form Price
N05BA12 ALPRAZOLAM BIOGARAN G Alprazolam - 0.5mg 0.5mg Tablet, scored 169,324 L.L
N05BA12 ALPRAZOLAM BIOGARAN G Alprazolam - 0.25mg 0.25mg Tablet, scored 115,570 L.L
A10BB01 GLIBENCLAMIDE G Glibenclamide - 5mg 5mg Tablet, scored 340,440 L.L
R06AE07 CETIMED G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, scored 360,918 L.L
N06AA01 DESIPRAMINE G Desipramine (HCl) - 50mg 50mg Tablet, scored 656,563 L.L
C01BC04 FLECAINE B Flecainide acetate - 100mg 100mg Tablet, scored 878,873 L.L
C08CA08 LUSOPRESS B Nitrendipine - 20mg 20mg Tablet, scored 757,927 L.L
C01BC04 FLECAINIDE ARROW LAB G Flecainide acetate - 100mg 100mg Tablet, scored 588,603 L.L
C01BD01 CORDARONE B Amiodarone (HCl) - 200mg 200mg Tablet, scored 349,399 L.L
M01AC01 BREXIN B Piroxicam-?-cyclodextrin - 20mg 20mg Tablet, scored 971,598 L.L
C08DB01 ZALDEM G Diltiazem HCl - 60mg 60mg Tablet, scored 199,657 L.L
C09AA01 APO-CAPTO G Captopril - 25mg 25mg Tablet, scored 1,132,859 L.L
C09AA01 CAPTACE G Captopril - 25mg 25mg Tablet, scored 486,343 L.L
C09AA01 CAPTOPRIL G Captopril - 25mg 25mg Tablet, scored 4,453,878 L.L
C09AA01 CAPTOPRIL G Captopril - 25mg 25mg Tablet, scored 355,798 L.L
C09AA01 APO-CAPTO G Captopril - 50mg 50mg Tablet, scored 1,752,371 L.L
C10AA01 VASCOR G Simvastatin - 10mg 10mg Tablet, scored 284,127 L.L
C09AA01 CAPTACE G Captopril - 50mg 50mg Tablet, scored 652,724 L.L
N06AB06 ZOLOFT B Sertraline HCl - 50mg 50mg Tablet, scored 596,666 L.L
N06AB06 ZOLOFT B Sertraline HCl - 50mg 50mg Tablet, scored 596,666 L.L
C10AA01 VASCOR G Simvastatin - 20mg 20mg Tablet, scored 284,127 L.L
A04AA01 NAUSETRON G Ondansetron (HCl dihydrate) - 8mg 8mg Tablet, scored 1,023,880 L.L
N06AB06 SERTINE G Sertraline HCl - 50mg 50mg Tablet, scored 520,899 L.L
C10AA01 STAVINE G Simvastatin - 40mg 40mg Tablet, scored 207,336 L.L
C10AA01 VASCOR G Simvastatin - 40mg 40mg Tablet, scored 284,127 L.L
C01DX12 CORVASAL 2MG B Molsidomine - 2mg 2mg Tablet, scored 398,033 L.L
C10AA03 STAVACOR G Pravastatin sodium - 40mg 40mg Tablet, scored 891,799 L.L
C01DX12 CORVASAL 2MG B Molsidomine - 2mg 2mg Tablet, scored 1,092,992 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
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