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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
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 50mg 50mg Capsule, extended release 1,154,361 L.L
J01AA08 VULGA XR G Minocycline - 55mg 55mg Tablet, film coated 1,983,512 L.L
L01EA01 IMATINIB SPC G Imatinib - 400mg 400mg Tablet, film coated 62,161,280 L.L
M01AB05 DICLOGESIC 12.5 CHILDREN G Diclofenac sodium - 12.5mg 12.5mg Suppository 83,318 L.L
N01AX10 DORMIFOR G Propofol - 1% 1% Injectable emulsion 1,081,473 L.L
N03AX14 LEVETIRACETAM BIOGARAN G Levetiracetam - 250mg 250mg Tablet, coated, scored 1,350,562 L.L
N05BA25 SEDOXIL G Mexazolam - 1mg 1mg Tablet 1,705,336 L.L
P02CB01 VERMIFUGE G Piperazine citrate - 1g/5ml 1g/5ml Syrup 148,463 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,240,367 L.L
A10BB12 ORBIDE G Glimepiride - 4mg 4mg Tablet 357,078 L.L
B01AB12 HIBOR G Bemiparin Sodium - 3,500IU 3,500IU Injectable solution 1,029,383 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 186,167 L.L
C09DX01 ARBITEN AM PLUS G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet 857,372 L.L
D06AX DERMOTRACIN G Neomycin sulfate - 165.000IU/150ml, Bacitracin - 15.500IU/150ml Powder 737,770 L.L
J01EE01 PAEDIATRIC CO-TRIMOXAZOLE MIXTURE G Trimethoprim - 40mg/5ml, Sulfamethoxazole - 200mg/5ml Suspension 190,698 L.L
L01EA01 SAGITTA G Imatinib - 400mg 400mg Capsule, hard 51,723,840 L.L
L02BA01 TAMOXIFENE BIOGARAN G Tamoxifen (citrate) - 10mg 10mg Tablet 415,247 L.L
N01AX10 PROPOFOL 1% MCT/LCT FRESENIUS G Propofol - 1% 1% Injectable emulsion 847,965 L.L
N03AX14 LEVIPRAM 250 G Levetiracetam - 250mg 250mg Tablet, film coated 1,087,873 L.L
N05CD08 MIDAZOLAM HAMELN G Midazolam (HCl) - 5mg/5ml 5mg/5ml Injectable solution 529,474 L.L
P02CB01 PIPERAZINE CITRATE G Piperazine citrate - 750mg/5ml 750mg/5ml Elixir 113,907 L.L
R06AB02 HISTAMED G Dexchlorpheniramine maleate - 1% 1% Gel 477,384 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,034,759 L.L
A10BB12 JOSWE GLEMAX 6 G Glimepiride - 6mg 6mg Caplet 663,858 L.L
B01AB12 HIBOR G Bemiparin Sodium - 5,000IU 5,000IU Injectable solution 1,466,132 L.L
B05BB02 MIXTE SIMPLE (2) G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C01BD01 AMIODARONE BIOGARAN G Amiodarone (HCl) - 200mg 200mg Tablet 345,368 L.L
C09DX01 LOTEVAN PLUS G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 857,372 L.L
D06AX PENICILLIN DERMIC OINTMENT G Penicillin - 5,000IU 5,000IU Ointment 80,631 L.L
J01AA12 TAGIX G Tigecycline - 50mg 50mg Injectable lyophilised powder for solution 2,436,386 L.L
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