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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
N03AG01 DEPAKINE B Sodium Valproate - 200mg/3.47ml 200mg/3.47ml Syrup 442,124 L.L
A03AB02 GLYCOPYRROLATE B Glycopyronium Bromide - 0.2mg/ml 0.2mg/ml Injectable solution 7,238,185 L.L
A12AA04 CALTRATE 600 B Calcium (carbonate) - 600mg 600mg Tablet 618,168 L.L
D01AC02 DAKTARIN B Miconazole nitrate - 20mg/g 20mg/g Cream 231,141 L.L
G02AD02 PROPESS B Dinoprostone - 10mg 10mg Vaginal delivery system 5,838,996 L.L
H02AB04 SOLU MEDROL B Methylprednisolone sodium succinate - 500mg 500mg Injectable powder for solution 718,956 L.L
J02AC03 V-FEND B Voriconazole - 200mg 200mg Injectable powder for solution 8,078,564 L.L
L01CA04 NAVELBINE B Vinorelbine (ditartrate) - 30mg 30mg Capsule, soft gelatin 6,072,824 L.L
A03AB06 SPASMOMEN B Otilonium bromide - 40mg 40mg Tablet, film coated 438,093 L.L
B05 20 MEQ POTASSIUM OF 5% DEXTROSE AND 0.45% SODIUM CHLORIDE INJECTION USP B Dextrose, H2O - 5%, Sodium chloride - 0.45%, Potassium chloride - 20meq Injectable solution 229,959 L.L
C09DA06 BLOPRESS PLUS 8MG B Candesartan cilexetil - 8mg, Hydrochlorothiazide - 12.5mg Tablet 1,060,292 L.L
N03AG01 DEPAKINE B Sodium Valproate - 200mg/ml 200mg/ml Solution 360,150 L.L
N07CA01 BETASERC B Betahistine dihydrochloride - 16mg 16mg Tablet 1,561,857 L.L
R05CB01 FLUIMUCIL B N-acetylcysteine - 600mg 600mg Tablet, effervescent 567,102 L.L
S02AA15 SEPTOCIPRO OTICO B Ciprofloxacine (HCl) - 1mg/0.5ml 1mg/0.5ml Solution 473,033 L.L
A12AA04 CI-CAL B Calcium citrate - 250mg 250mg Tablet 694,767 L.L
B05 20 MEQ POTASSIUM OF 0.9% SODIUM CHLORIDE INJECTION USP B Sodium chloride - 0.9%, Potassium chloride - 20meq Injectable solution 278,102 L.L
C07AB07/C09CA CONCOR T 2.5 B Bisoprolol fumarate - 2.5mg, Telmisartan - 40mg Tablet 1,118,900 L.L
H02AB04 SOLU MEDROL B Methylprednisolone sodium succinate - 1g 1g Injectable powder for solution 1,444,631 L.L
J02AC04 NOXAFIL B Posaconazole - 100mg 100mg Tablet, gastroresistant 62,027,714 L.L
L04AX04 REVLIMID B Lenalidomide - 15mg 15mg Capsule 116,241,703 L.L
M04AA03 ADENURIC B Febuxostat - 40mg 40mg Tablet, film coated 1,687,866 L.L
N03AG01 DEPAKINE B Sodium Valproate - 500mg 500mg Tablet, enteric coated 479,752 L.L
A03AX COLPERMIN B Pepermint oil - 187mg 187mg Capsule, delayed release 632,950 L.L
A12AX DECALCIT B Vitamin D3 - 500IU, Calcium - 600mg Tablet 912,469 L.L
B05 20 MEQ POTASSIUM OF 0.9% SODIUM CHLORIDE INJECTION USP B Sodium chloride - 0.9%, Potassium chloride - 20mEq Injectable solution 229,959 L.L
C07AB07/C09CA CONCOR T 2.5 B Bisoprolol fumarate - 2.5mg, Telmisartan - 40mg Tablet 2,125,622 L.L
C09DA07 MICARDIS PLUS B Telmisartan - 80mg, Hydrochlorothiazide - 12.5mg Tablet 1,101,951 L.L
J02AC05 CRESEMBA B Isavuconazonium sulfate - 100mg 100mg Capsule, hard 69,290,804 L.L
R05CB01 EXOMUC B N-acetylcysteine - 200mg 200mg Granules for solution 588,603 L.L
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