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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
V03AC03 JADENU B Deferasirox - 180mg 180mg Tablet, film coated 34,062,918 L.L
V03AC03 JADENU B Deferasirox - 360mg 360mg Tablet, film coated 57,962,964 L.L
L01EJ01 JAKAVI B Ruxolitinib - 5mg 5mg Tablet 151,681,526 L.L
L01EJ01 JAKAVI B Ruxolitinib - 15mg 15mg Tablet 299,313,035 L.L
L01EJ01 JAKAVI B Ruxolitinib - 20mg 20mg Tablet 299,313,035 L.L
A04AA01 JAMP ONDANSETRON G Ondansetron (HCl dihydrate) - 4mg/5ml 4mg/5ml Solution 2,687,685 L.L
M03BX08 JAMP-CYCLOBENZAPRINE G Cyclobenzaprine HCl - 10mg 10mg Tablet 4,031,528 L.L
A10BD07 JANUMET B Metformin HCl - 1000mg, Sitagliptin - 50mg Tablet 3,093,525 L.L
A10BD07 JANUMET B Metformin HCl - 1000mg, Sitagliptin - 50mg Tablet 3,093,525 L.L
A10BD07 JANUMET B Metformin HCl - 500mg, Sitagliptin - 50mg Tablet 3,237,317 L.L
A10BD07 JANUMET B Metformin HCl - 500mg, Sitagliptin - 50mg Tablet 3,237,317 L.L
A10BD07 JANUMET XR B Metformin HCl - 500mg, Sitagliptin - 50mg Tablet 4,777,360 L.L
A10BD07 JANUMET XR B Metformin HCl - 1,000mg, Sitagliptin - 50mg Tablet 4,777,360 L.L
A10BD07 JANUMET XR B Metformin HCl - 1,000mg, Sitagliptin - 100mg Tablet 4,777,360 L.L
A10BH01 JANUVIA B Sitagliptin - 100mg 100mg Tablet, film coated 1,884,067 L.L
A10BK03 JARDIANCE B Empagliflozin - 25mg 25mg Tablet, film coated 3,081,700 L.L
A10BK03 JARDIANCE B Empagliflozin - 10mg 10mg Tablet, film coated 3,081,700 L.L
B03BA01 JECTIN-12 G Cyanocobalamin - 1000mcg/1ml 1000mcg/1ml Injectable solution 567,102 L.L
D06BB10 JEDARA G Imiquimod - 5% 5% Cream 3,850,109 L.L
A10BD11 JENTADUETO B Metformin - 1000mg, Linagliptin - 2.5mg Tablet, film coated 3,542,369 L.L
A10BD11 JENTADUETO B Metformin - 850mg, Linagliptin - 2.5mg Tablet, film coated 3,542,369 L.L
L01CD04 JEVTANA INJECTION B Cabazitaxel - 60mg/1.5ml 60mg/1.5ml Injectable dry powder for solution+diluent 75,619,931 L.L
L01CD04 JEVTANA INJECTION B Cabazitaxel - 60mg/1.5ml 60mg/1.5ml Injectable dry powder for solution+diluent 75,619,931 L.L
M01AB05 JOFLAM G Diclofenac potassium - 50mg 50mg Tablet, film coated 322,522 L.L
R05CA12 JOS-PAN G Dried Ivy leaf extract (Hederacoside C) - 75mg/100ml Syrup 306,396 L.L
N05AX12 JOSWE ARIPAL 10 G Aripiprazole - 10mg 10mg Tablet 2,210,621 L.L
N05AX12 JOSWE ARIPAL 15 G Aripiprazole - 15mg 15mg Tablet 2,413,541 L.L
N05AX12 JOSWE ARIPAL 30 G Aripiprazole - 30mg 30mg Tablet 4,687,323 L.L
N05AX12 JOSWE ARIPAL 5 G Aripiprazole - 5mg 5mg Tablet 1,389,533 L.L
C10AA05 JOSWE ATORVAST 10 G Atorvastatin - 10mg 10mg Caplet, film coated 849,308 L.L
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