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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
L01EA02 DALEUBIN G Dasatinib - 20mg 20mg Tablet, film coated 79,249,265 L.L
L02BG03 VICTEVE G Anastrozole - 1mg 1mg Tablet, film coated 1,151,673 L.L
R06AE09 XYZAL B Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 572,477 L.L
C10AA01 SIMVAKEY G Simvastatin - 20mg 20mg Tablet, film coated 716,268 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 20mg 20mg Tablet, film coated 103,165,573 L.L
L02BG03 ZORTEX G Anastrozole - 1mg 1mg Tablet, film coated 1,944,092 L.L
R06AE09 CALIVIDA G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 447,948 L.L
A10BD07 SAGIMET G Metformin HCl - 850mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,463,892 L.L
C10AA01 SIMVASTATIN NORMON G Simvastatin - 20mg 20mg Tablet, film coated 264,737 L.L
L01EA02 ELPIDA G Dasatinib - 20mg 20mg Tablet, film coated 103,165,573 L.L
L02BG04 FEMARA B Letrozole - 2.5mg 2.5mg Tablet, film coated 3,433,518 L.L
R06AE09 LEVOTREX G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 447,948 L.L
A10BD07 SITAMET G Metformin - 850mg, Sitagliptin - 50mg Tablet, film coated 2,301,079 L.L
C10AA01 SIMVASTATIN-REMEDICA G Simvastatin - 20mg 20mg Tablet, film coated 542,912 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 1g 1,000mg Tablet, film coated 657,246 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 140mg 140mg Tablet, film coated 254,729,810 L.L
R06AE09 LIVIDA G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 447,948 L.L
A10BD07 SITAVITEA G Metformin - 850mg, Sitagliptin - 50mg Tablet, film coated 1,079,106 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 140mg 140mg Tablet, film coated 127,364,905 L.L
L02BG04 FEMAPLEX G Letrozole - 2.5mg 2.5mg Tablet, film coated 1,583,046 L.L
R06AE09 ZOLICIN G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 228,453 L.L
J01FA10 AZICIN 250 BENTA G Azithromycin - 250mg 250mg Tablet, film coated 423,630 L.L
L02BG04 FEMAZOL G Letrozole - 2.5mg 2.5mg Tablet, film coated 1,433,432 L.L
A10BD08 GALVUS MET B Metformin HCl - 1,000mg, Vildagliptin - 50mg Tablet, film coated 1,816,875 L.L
C09AA04 COVERSYL ARGININE B Perindopril arginine - 10mg 10mg Tablet, film coated 452,875 L.L
J01FA10 AZIFAST 250 G Azithromycin - 250mg 250mg Tablet, film coated 423,630 L.L
L02BG04 LEFFTARA G Letrozole - 2.5mg 2.5mg Tablet, film coated 2,060,111 L.L
M01AC56 MOBITIL G Meloxicam - 15mg, Beta-cyclodextrine - 75mg Tablet, film coated 212,327 L.L
A10BD08 GLUNORM M G Metformin HCl - 1000mg, Vildagliptin - 50mg Tablet, film coated 1,089,856 L.L
C09AA04 COVERSYL ARGININE B Perindopril arginine - 5mg 5mg Tablet, film coated 452,875 L.L
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