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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
N05AH04 QUETIAPINE BIOGARAN L.P. G Quetiapine fumarate - 400mg 400mg Tablet, prolonged release 2,612,430 L.L
N05AN01 MANICARB SR-400 G Lithium carbonate - 400mg 400mg Tablet, prolonged release 1,431,192 L.L
A08AA62 CONTRAVE B Naltrexone Hydrochloride - 8mg, Bupropion Hydrochloride - 90mg Tablet, prolonged release 11,653,550 L.L
N03AF01 NEUROTOP RETARD G Carbamazepine - 600mg 600mg Tablet, prolonged release 1,569,608 L.L
N03AF01 NEUROTOP RETARD G Carbamazepine - 300mg 300mg Tablet, prolonged release 931,283 L.L
N03AG01 CONVULEX RETARD G Sodium Valproate - 500mg 500mg Tablet, prolonged release 423,310 L.L
N07XX07 FAMPYRA B Fampridine - 10mg 10mg Tablet, prolonged release 17,636,804 L.L
N07XX07 FAMPYRA B Fampridine - 10mg 10mg Tablet, prolonged release 18,175,448 L.L
A10BA02 GLUCOPHAGE XR B Metformin HCl - 750mg 750mg Tablet, prolonged release 665,875 L.L
A10BA02 GLUCOPHAGE XR B Metformin HCl - 1000mg 1000mg Tablet, prolonged release 726,278 L.L
M01AB05 OLFEN-75 SR G Diclofenac sodium - 75mg 75mg Tablet, prolonged release 326,554 L.L
A10BA02 GLUCOPHAGE XR B Metformin HCl - 500mg 500mg Tablet, prolonged release 465,968 L.L
C08CA05 NIFELAT 30 LA G Nifedipine - 30mg 30mg Tablet, prolonged release 1,007,882 L.L
C08CA05 NIFELAT 60 LA G Nifedipine - 60mg 60mg Tablet, prolonged release 1,290,089 L.L
M01AE03 BI-PROFENID LP B Ketoprofen - 100mg 100mg Tablet, prolonged release 392,402 L.L
G04BD12 BETMIGA B Mirabegron - 50mg 50mg Tablet, prolonged release 3,758,727 L.L
C01EB18 RANEXA B Ranolazine - 375mg 375mg Tablet, prolonged release 3,985,837 L.L
C01EB18 RANEXA B Ranolazine - 500mg 500mg Tablet, prolonged release 3,985,837 L.L
C01EB18 RANEXA B Ranolazine - 750mg 750mg Tablet, prolonged release 3,985,837 L.L
N06AX16 VENLAFAXINE ARROW GENERIQUES LP G Venlafaxine - 75mg 75mg Tablet, prolonged release 1,075,074 L.L
N06AX16 VENLAFAXINE ARROW GENERIQUES LP G Venlafaxine - 150mg 150mg Tablet, prolonged release 987,724 L.L
C03BA11 RAWEL SR G Indapamide - 1.5mg 1.5mg Tablet, prolonged release 362,837 L.L
L04AA44 RINVOQ B Upadacitinib - 15mg 15mg Tablet, prolonged release 45,469,094 L.L
R06AX CLARINASE B Loratadine - 5mg, Pseudoephedrine sulfate - 120mg Tablet, repetab 446,156 L.L
R03DA05 AMINOPHYLLINE G Aminophylline - 100mg 100mg Tablet, scored 445,388 L.L
J01RA MEDSPIRAGYL G Metronidazole - 125mg, Spiramycin - 750,000IU Tablet, scored 474,824 L.L
J01RA SPIRAGYL G Metronidazole - 125mg, Spiramycin - 750,000IU Tablet, scored 474,824 L.L
J01RA SPIRAGYL FORTE G Metronidazole - 250mg, Spiramycin - 1,500,000IU Tablet, scored 474,824 L.L
C09CA06 CANDESARTAN BIOGARAN G Candesartan cilexetil - 8mg 8mg Tablet, scored 434,061 L.L
C09CA06 CANDESARTAN BIOGARAN G Candesartan cilexetil - 16mg 16mg Tablet, scored 434,061 L.L
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