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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
H02AB07 PREDNISONE G Prednisone - 5mg 5mg Tablet, scored 176,619 L.L
C07AB12 NEBIVOLOL BIOGARAN G Nebivolol HCl - 5mg 5mg Tablet, scored 529,474 L.L
H02AB07 PREDICOR G Prednisone - 20mg 20mg Tablet, scored 346,839 L.L
H02AB07 PREDNISONE G Prednisone - 20mg 20mg Tablet, scored 346,839 L.L
H02AB07 PREDICOR G Prednisone - 10mg 10mg Tablet, scored 386,515 L.L
J05AB01 ACTI-VIR G Aciclovir - 200mg 200mg Tablet, scored 1,039,238 L.L
C07AG02 DILATREND B Carvedilol - 6.25mg 6.25mg Tablet, scored 364,181 L.L
H02AB07 PREDNISONE G Prednisone - 10mg 10mg Tablet, scored 386,515 L.L
J05AB01 CYCLOVEX G Aciclovir - 200mg 200mg Tablet, scored 1,164,664 L.L
H02AB07 PREDICOR G Prednisone - 50mg 50mg Tablet, scored 712,876 L.L
J05AB01 CYCLOVEX G Aciclovir - 400mg 400mg Tablet, scored 2,687,685 L.L
H02AB07 PREDNISONE G Prednisone - 50mg 50mg Tablet, scored 742,313 L.L
C07AG02 DILATREND B Carvedilol - 25mg 25mg Tablet, scored 598,010 L.L
H02AB09 HYDROCORTISONE ROUSSEL B Hydrocortisone - 10mg 10mg Tablet, scored 260,705 L.L
D01BA01 GRISEOFULVIN G Griseofulvin - 500mg 500mg Tablet, scored 575,933 L.L
D01BA02 LAMISIL B Terbinafine HCl - 250mg 250mg Tablet, scored 813,025 L.L
N05BA01 VALIUM B Diazepam - 5mg 5mg Tablet, scored 200,233 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 25mcg 25mcg Tablet, scored 256,674 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 50mcg 50mcg Tablet, scored 391,058 L.L
H03AA01 ELTROXIN B Levothyroxine sodium - 100mcg 100mcg Tablet, scored 440,780 L.L
D01BA02 TERAFAN G Terbinafine HCl - 250mg 250mg Tablet, scored 725,675 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 100mcg 100mcg Tablet, scored 452,875 L.L
N05BA06 LORAZEPAM G Lorazepam - 1mg 1mg Tablet, scored 325,082 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 150mcg 150mcg Tablet, scored 615,480 L.L
N05BA06 LORAZEPAM G Lorazepam - 2mg 2mg Tablet, scored 485,063 L.L
N05BA08 LEXOTANIL B Bromazepam - 3mg 3mg Tablet, scored 413,903 L.L
N05BA08 ANXYL G Bromazepam - 3mg 3mg Tablet, scored 167,660 L.L
N05BA08 LEXOTANIL B Bromazepam - 1.5mg 1.5mg Tablet, scored 299,677 L.L
N05BA08 BROMAZEPAM BIOGARAN G Bromazepam - 6mg 6mg Tablet, scored 180,075 L.L
C08CA01 AMLINE G Amlodipine - 5mg 5mg Tablet, scored 358,358 L.L
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