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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
C05CX GINKGO BIOGARAN G Ginkgo biloba extract - 40mg 40mg Tablet, coated 345,368 L.L
C05CX GINKGO BIOGARAN G Ginkgo biloba extract - 40mg 40mg Tablet, coated 985,037 L.L
N06DA02 DONEPEZIL BIOGARAN G Donepezil HCl - 5mg 5mg Tablet, coated 1,325,029 L.L
N06DA02 DONEPEZIL BIOGARAN G Donepezil HCl - 10mg 10mg Tablet, coated 1,325,029 L.L
C09DA01 LOSARTAN/HYDROCHLOROTHIAZIDE BGR G Losartan potassium - 50mg, Hydrochlorothiazide - 12.5mg Tablet, coated 439,436 L.L
C09DA01 LOSARTAN/HYDROCHLOROTHIAZIDE BGR G Losartan potassium - 100mg, Hydrochlorothiazide - 25mg Tablet, coated 439,436 L.L
J01XX08 LINEZOLIDE STRAGEN G Linezolide - 600mg 600mg Tablet, coated 5,848,403 L.L
B03BA01 COBAL G Vitamin B12 - 500mcg 500mcg Tablet, coated 486,471 L.L
C07AB04 ACEBUTOLOL BIOGARAN G Acebutolol HCl - 400mg 400mg Tablet, coated 615,480 L.L
C07AB04 ACEBUTOLOL BIOGARAN G Acebutolol HCl - 200mg 200mg Tablet, coated 464,970 L.L
A11DB NEUROBION B Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet, coated 364,181 L.L
A11DB NEUROBION B Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet, coated 550,975 L.L
L01BC06 CAPECITABINE BIOGARAN G Capecitabine - 500mg 500mg Tablet, coated 12,123,049 L.L
A11DB MED-PRINCO-B FORT G Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet, coated 386,515 L.L
A11DB NEUROMED G Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet, coated 257,250 L.L
C07AB07 CARDIOSAFE 5 G Bisoprolol fumarate - 5mg 5mg Tablet, coated 330,585 L.L
N06DX01 MEMANTINE BIOGARAN G Memantine HCl - 20mg 20mg Tablet, coated 2,444,450 L.L
C07AB07 CARDIOSAFE 10 G Bisoprolol fumarate - 10mg 10mg Tablet, coated 610,104 L.L
A11JC CYSTINE B6 BAILLEUL B Pyridoxine HCl - 50mg, L-Cystine - 500mg Tablet, coated 862,747 L.L
A03A SPASMOBROM B Pipethanate Ethobromide - 20mg 20mg Tablet, coated 705,517 L.L
J02AC03 VORICONAZOLE STRAGEN G Voriconazole - 50mg 50mg Tablet, coated 15,808,184 L.L
J02AC03 VORICONAZOLE STRAGEN G Voriconazole - 200mg 200mg Tablet, coated 40,202,793 L.L
A03AX12 SPASFON B Phloroglucinol hydrate - 80mg, Trimethylphloroglucinol - 80mg Tablet, coated 278,175 L.L
M05BA04 MARVIL 70 G Alendronate (monosodium trihydrate) - 70mg 70mg Tablet, coated 1,173,175 L.L
A03AX13 MOSAR PLUS B Mosapride citrate - 5mg, Simethicone - 200mg Tablet, coated 865,435 L.L
M05BA04 OREK G Alendronate - 70mg 70mg Tablet, coated 2,404,838 L.L
A12CC MAGNE B6 B Pyridoxine HCl - 5mg, Magnesium lactate dihydrate - 470mg Tablet, coated 365,525 L.L
A12CC MAGNE B6 B Pyridoxine HCl - 5mg, Magnesium lactate dihydrate - 470mg Tablet, coated 365,525 L.L
M05BA06 ADROMUX G Ibandronic acid - 150mg 150mg Tablet, coated 821,088 L.L
C09DB01 AMLODIPINE/VALSARTAN ARROW G Amlodipine (besylate) - 5mg, Valsartan - 160mg Tablet, coated 923,220 L.L
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