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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
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 160,885 L.L
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 176,974 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 145,946 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 151,692 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 164,333 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 688,359 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 144,797 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 182,720 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 209,151 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 222,941 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 181,570 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 219,493 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 170,079 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 194,211 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 284,997 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 220,643 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 252,820 L.L
A12AA03 10% W/V CALCIUM GLUCONATE INJECTION BP G Calcium gluconate - 10% 10% Injectable solution 3,952,241 L.L
R05D 123 COLD AND FLU B Phenylephrine HCl - 5mg, Carbinoxamine HCl - 3mg, Caffeine anhydrous - 30mg, Codeine phosphate - 8mg, Acetaminophen - 325mg Tablet 409,552 L.L
N02BE51 123 COMPLETE B Acetaminophen (day tablet, night tablet) - 500mg, Dextromethorphan HBr (day tablet, night tablet) - 5mg, Phenylephrine HCl (day tablet, night tablet) - 5mg, Carbinoxamine maleate (night tablet) - 3mg Tablet 537,537 L.L
B05BB02 2.5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 2.5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 172,377 L.L
B05BB02 2.5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 2.5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 224,090 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
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
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
A11DB 3V G Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet 229,797 L.L
A11DB 3V G Vitamin B12 - 1mg/3ml, Vitamin B6 - 100mg/3ml, Vitamin B1 - 100mg/3ml Injectable solution 198,889 L.L
B05BB02 5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 179,272 L.L
B05BB02 5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 224,090 L.L
B05BB02 5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml Injectable solution 180,421 L.L
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