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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
S01ED51 XALACOM B Timolol (maleate) - 6.8mg/ml, Latanoprost - 50?g/ml Drops solution 510,660 L.L
S01EE01 XALATAN B Latanoprost - 50mcg/ml 50mcg/ml Drops solution 704,173 L.L
N05AX12 XALIPRO G Aripiprazole - 10mg 10mg Tablet 2,123,271 L.L
N05AX12 XALIPRO G Aripiprazole - 15mg 15mg Tablet 2,418,917 L.L
N05AX12 XALIPRO G Aripiprazole - 5mg 5mg Tablet 1,746,995 L.L
L01ED01 XALKORI B Crizotinib - 250mg 250mg Capsule 347,644,061 L.L
L01ED01 XALKORI B Crizotinib - 200mg 200mg Capsule 347,644,061 L.L
L01ED01 XALKORI B Crizotinib - 250mg 250mg Capsule L.L
N05BA12 XANAX B Alprazolam - 0.5mg 0.5mg Tablet 477,064 L.L
B01AF01 XARELTO B Rivaroxaban - 2.5mg 2.5mg Tablet, film coated 4,045,168 L.L
B01AF01 XARELTO B Rivaroxaban - 15mg 15mg Tablet, film coated 4,440,862 L.L
B01AF01 XARELTO B Rivaroxaban - 20mg 20mg Tablet, film coated 4,440,862 L.L
B01AF01 XARELTO B Rivaroxaban - 10mg 10mg Tablet, film coated 1,588,892 L.L
G04CA01 XATRAL XL B Alfuzosin HCl - 10mg 10mg Tablet, prolonged release 1,061,636 L.L
B01AF01 XAVIRAN G Rivaroxaban - 15mg 15mg Tablet, film coated 952,208 L.L
B01AF01 XAVIRAN G Rivaroxaban - 20mg 20mg Tablet, film coated 952,208 L.L
B01AF01 XAVIRAN G Rivaroxaban - 10mg 10mg Tablet, film coated 606,649 L.L
L04AA29 XELJANZ B Tofacitinib - 5mg 5mg Tablet 80,685,473 L.L
L04AA29 XELJANZ XR B Tofacitinib - 11mg 11mg Tablet, extended release 78,687,316 L.L
L01BC06 XELODA B Capecitabine - 500mg 500mg Tablet, film coated 17,946,398 L.L
D07AC13 XEMADERM G Mometasone furoate - 0.1% 0.1% Cream 335,961 L.L
A08AB01 XENICAL B Orlistat - 120mg 120mg Capsule 4,036,903 L.L
M03AX01 XEOMIN BioTech Clostridium botulinum type A neurotoxin complex - 100 units LD50 100 units LD50 Injectable powder for solution 20,517,541 L.L
M03AX01 XEOMIN BioTech Clostridium botulinum type A neurotoxin complex - 50 units LD50 50 units LD50 Injectable powder for solution 11,920,109 L.L
J01DD15 XEVANEER G Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 1,308,903 L.L
J01DD15 XEVANEER G Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 686,704 L.L
J01DD15 XEVANEER G Cefdinir - 300mg 300mg Capsule 1,350,562 L.L
M05BX04 XGEVA BioTech Denosumab - 120mg 120mg Injectable solution 33,545,669 L.L
A10BD15 XIGDUO XR B Metformin HCl XR - 1000mg, Dapagliflozin - 5mg Tablet 3,867,041 L.L
A10BD15 XIGDUO XR B Metformin HCl XR - 1000mg, Dapagliflozin - 10mg Tablet 3,006,579 L.L
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