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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
L04AD02 PROGRAF 1MG B Tacrolimus - 1mg 1mg Capsule 25,241,922 L.L
M03BB53 RELAXON G Paracetamol - 300mg, Chlorzoxazone - 250mg Capsule 296,989 L.L
J01XE01 UVAMIN RETARD G Nitrofurantoin (macrocrystals) - 100mg 100mg Capsule 392,402 L.L
L04AD02 PROGRAF 1MG B Tacrolimus - 1mg 1mg Capsule 25,241,922 L.L
A02BC01 SANAMIDOL G Omeprazole - 20mg 20mg Capsule 456,906 L.L
C05BX01 DOXIUM B Calcium dobesilate - 500mg 500mg Capsule 2,151,492 L.L
G04CB02 AVODART B Dutasteride - 0.5mg 0.5mg Capsule 2,568,489 L.L
L04AD02 TACROGRAF 1 G Tacrolimus - 1mg 1mg Capsule 12,679,940 L.L
A02BC01 HYPOSEC G Omeprazole - 20mg 20mg Capsule 659,827 L.L
C05BX01 DOXIUM B Calcium dobesilate - 500mg 500mg Capsule 1,323,685 L.L
L04AD02 PROGRAF 5MG B Tacrolimus - 5mg 5mg Capsule 94,286,686 L.L
A02BC01 GASTRAZOLE G Omeprazole - 20mg 20mg Capsule 245,923 L.L
G04CB02 DUTASTERIDE ARROW LAB G Dutasteride - 0.5mg 0.5mg Capsule 1,166,455 L.L
L04AD02 PROGRAF 5MG B Tacrolimus - 5mg 5mg Capsule 94,286,686 L.L
A02BC01 GASTRISEC G Omeprazole - 20mg 20mg Capsule 413,903 L.L
L04AD02 TACROGRAF 5 G Tacrolimus - 5mg 5mg Capsule 67,507,154 L.L
L04AD02 PROGRAF 0.5 MG B Tacrolimus - 0.5mg 0.5mg Capsule 13,942,481 L.L
L04AD02 PROGRAF 0.5 MG B Tacrolimus - 0.5mg 0.5mg Capsule 13,942,481 L.L
C05CA05 VENOSMIL G Hidrosmin - 200mg 200mg Capsule 976,973 L.L
L04AD02 TACROGRAF 0.5 G Tacrolimus - 0.5mg 0.5mg Capsule 7,004,024 L.L
A02BC01 HYPOSEC G Omeprazole - 20mg 20mg Capsule 1,478,227 L.L
A02BC01 AXIPRON G Omeprazole - 20mg 20mg Capsule 373,358 L.L
A11AA PANTOGAR B P-aminobenzoic acid - 20mg, Keratine - 20mg, Medical yeast - 100mg, Thiamine mononitrate - 60mg, L-Cystine - 20mg, Calcium D-pantothenate - 60mg Capsule 2,005,013 L.L
C05CA54 GINKOR FORT B Heptaminol HCl - 0.300g, Troxerutine - 0.300g, Ginkgo biloba extract - 0.014g Capsule 681,328 L.L
L04AX02 THALIDOMIDE CELGENE B Thalidomide - 50mg 50mg Capsule 27,387,764 L.L
A02BC01 OMEZOL BENTA G Omeprazole - 20mg 20mg Capsule 550,336 L.L
L04AX02 THALIDOMIDE BMS B Thalidomide - 50mg 50mg Capsule 27,387,764 L.L
N03AB02 EPANUTIN B Phenytoin sodium - 100mg 100mg Capsule 739,113 L.L
A02BC01 OMEPRAZOLE PHARMADEX G Omeprazole - 20mg 20mg Capsule 415,951 L.L
B02BX01 DICYNONE B Etamsylate - 500mg 500mg Capsule 1,311,590 L.L
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