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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
N05AH03 ZOLAPINE G Olanzapine - 5mg 5mg Tablet, orodispersible 1,186,165 L.L
N05AH03 ZYRWAN OD G Olanzapine - 5mg 5mg Tablet, orodispersible 831,391 L.L
N05AH03 PRANZA G Olanzapine - 10mg 10mg Tablet, orodispersible 3,553,120 L.L
N05AH03 ZOLAPINE G Olanzapine - 10mg 10mg Tablet, orodispersible 2,106,249 L.L
N05AH03 ZYRWAN OD G Olanzapine - 10mg 10mg Tablet, orodispersible 2,564,819 L.L
N06DA02 DONEPEZIL/ GENEPHARM G Donepezil - 10mg 10mg Tablet, orodispersible 1,779,247 L.L
N06DA02 YASNAL Q-TAB G Donepezil - 10mg 10mg Tablet, orodispersible 1,376,095 L.L
N06DA02 DONEPEZIL/ GENEPHARM G Donepezil - 5mg 5mg Tablet, orodispersible 1,634,112 L.L
N06DA02 YASNAL Q-TAB G Donepezil - 5mg 5mg Tablet, orodispersible 1,376,095 L.L
N02CC03 ZOLMITRIPTAN BIOGARAN G Zolmitriptan - 2.5mg 2.5mg Tablet, orodispersible 921,876 L.L
N02CC03 ZOLMITRIPTAN BIOGARAN G Zolmitriptan - 2.5mg 2.5mg Tablet, orodispersible 1,683,835 L.L
N05AX12 ZALONIL G Aripiprazole - 10mg 10mg Tablet, orodispersible 1,988,887 L.L
A03FA03 MOTIDOL ODT G Domperidone - 10mg 10mg Tablet, orodispersible 259,810 L.L
N05AX12 ZALONIL G Aripiprazole - 15mg 15mg Tablet, orodispersible 2,426,980 L.L
A04AA01 ONDANSETRON ARROW G Ondansetron - 8mg 8mg Tablet, orodispersible 1,280,682 L.L
A04AA01 ONZETRAN OD G Ondansetron - 8mg 8mg Tablet, orodispersible 1,023,880 L.L
A04AA01 ZONETRON ODT G Ondansetron - 8mg 8mg Tablet, orodispersible 998,283 L.L
A04AA01 ZONETRON ODT G Ondansetron - 4mg 4mg Tablet, orodispersible 972,686 L.L
G04BD12 BETMIGA B Mirabegron - 50mg 50mg Tablet, prolonged release 3,758,727 L.L
C03BA11 ADEX G Indapamide - 1.5mg 1.5mg Tablet, prolonged release 296,989 L.L
C03BA11 RAWEL SR G Indapamide - 1.5mg 1.5mg Tablet, prolonged release 362,837 L.L
A07EA06 CORTIMENT MMX B Budesonide - 9mg 9mg Tablet, prolonged release 8,996,996 L.L
M01AE03 BI-PROFENID LP B Ketoprofen - 100mg 100mg Tablet, prolonged release 392,402 L.L
N06AX16 VENLAFAXINE ARROW GENERIQUES LP G Venlafaxine - 75mg 75mg Tablet, prolonged release 1,075,074 L.L
A08AA62 CONTRAVE B Naltrexone Hydrochloride - 8mg, Bupropion Hydrochloride - 90mg Tablet, prolonged release 11,653,550 L.L
N06AX16 VENLAFAXINE ARROW GENERIQUES LP G Venlafaxine - 150mg 150mg Tablet, prolonged release 987,724 L.L
G04CA01 XATRAL XL B Alfuzosin HCl - 10mg 10mg Tablet, prolonged release 1,061,636 L.L
L04AA44 RINVOQ B Upadacitinib - 15mg 15mg Tablet, prolonged release 45,469,094 L.L
N05AH04 QUETIAPINE BIOGARAN L.P. G Quetiapine fumarate - 300mg 300mg Tablet, prolonged release 1,759,090 L.L
N05AH04 QUETIAPINE BIOGARAN L.P. G Quetiapine fumarate - 50mg 50mg Tablet, prolonged release 1,010,570 L.L
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