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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
N05AX08 RISPERDAL B Risperidone - 4mg 4mg Tablet, film coated 498,566 L.L
N07BC01 BUVIDAL B Buprenorphine - 32mg 32mg Injectable solution prolonged release 8,524,771 L.L
S01XA18 RESTASIS B Ciclosporin - 0.5mg/ml 0.05% Emulsion 4,100,063 L.L
A02BX13 GAVISCON DOUBLE ACTION B Sodium alginate - 500mg, Sodium bicarbonate - 213mg, Calcium (carbonate) - 325mg Suspension 517,379 L.L
A11JC CYSTINE B6 BAILLEUL B Pyridoxine HCl - 50mg, L-Cystine - 500mg Tablet, coated 862,747 L.L
C10BX06 TRINOMIA B Acetylsalicylic acid - 100mg, Atorvastatin - 20mg, Ramipril - 2.5mg Capsule, hard 1,029,383 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 2 Billions/5ml Suspension 595,322 L.L
L01BC59 LONSURF B Trifluridine - 20mg, Tipiracil - 8.19mg Tablet, film coated 75,019,126 L.L
N07BC01 BUVIDAL B Buprenorphine - 64mg 64mg Injectable solution prolonged release 34,835,645 L.L
S01XA18 RESTASIS B Ciclosporin - 0.5mg/ml 0.05% Emulsion 4,100,063 L.L
A03A SPASMOBROM B Pipethanate Ethobromide - 20mg 20mg Tablet, coated 705,517 L.L
C10BX06 TRINOMIA B Acetylsalicylic acid - 100mg, Atorvastatin - 20mg, Ramipril - 5mg Capsule, hard 1,236,335 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 2 Billions Capsule 831,839 L.L
L01BC59 LONSURF B Trifluridine - 15mg, Tipiracil - 6.14mg Tablet, film coated 58,102,683 L.L
N07BC01 BUVIDAL B Buprenorphine - 96mg 96mg Injectable solution prolonged release 34,835,645 L.L
A03AA04 DUSPATALIN RETARD B Mebeverine HCl - 200mg 200mg Capsule 861,466 L.L
C09DA06 ATACAND PLUS B Candesartan cilexetil - 16mg, Hydrochlorothiazide - 12.5mg Tablet 705,517 L.L
C10BX06 TRINOMIA B Acetylsalicylic acid - 100mg, Atorvastatin - 20mg, Ramipril - 10mg Capsule, hard 1,596,485 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 6 Billions/2g 6 billions/2g Powder for suspension 1,493,009 L.L
J02AC03 VFEND B Voriconazole - 200mg 200mg Tablet, film coated 51,904,550 L.L
M04AA03 ADENURIC B Febuxostat - 80mg 80mg Tablet, film-scored 2,127,111 L.L
N03AF01 TEGRETOL B Carbamazepine - 2% 2% Suspension 456,906 L.L
N07BC01 BUVIDAL B Buprenorphine - 128mg 128mg Injectable solution prolonged release 34,835,645 L.L
C09DA06 BLOPRESS PLUS 16MG B Candesartan cilexetil - 16mg, Hydrochlorothiazide - 12.5mg Tablet 1,257,837 L.L
D01AC01 CANESTEN B Clotrimazole - 0.01g/ml 0.01g/ml Solution 368,213 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 6 Billions/2g 6 billions/2g Powder for suspension 1,343,843 L.L
N03AF04 ZEBINIX B Eslicarbazepine acetate - 800mg 800mg Tablet 11,123,961 L.L
S01XA20 TEARS NATURALE B Duasorb - 0.4% 0.4% Drops solution 189,482 L.L
D01AC01 CANESTEN B Clotrimazole - 0.01g/g 0.01g/g Cream 344,024 L.L
L01CA04 NAVELBINE B Vinorelbine (ditartrate) - 20mg 20mg Capsule, soft gelatin 4,048,997 L.L
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