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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
N06AB03 FLUOXETINE BIOGARAN G Fluoxetine (HCl) - 20mg 20mg Capsule 239,204 L.L
L01EX01 SUTENT B Sunitinib maleate - 50mg 50mg Capsule L.L
J01CA04 AMOXICILLIN G Amoxicillin (trihydrate) - 500mg 500mg Capsule 6,199,145 L.L
N03AX16 NEUREXAL G Pregabalin - 150mg 150mg Capsule 754,856 L.L
N06AB03 NEANXETIN G Fluoxetine (HCl) - 20mg 20mg Capsule 422,351 L.L
J01CA04 AMOXICILLINE ARROW LAB G Amoxicillin (trihydrate) - 500mg 500mg Capsule 564,414 L.L
N03AX16 PLENICA G Pregabalin - 150mg 150mg Capsule 997,131 L.L
J01CA04 AMOXIDREX G Amoxicillin (trihydrate) - 500mg 500mg Capsule 254,690 L.L
N03AX16 PMS-PREGABALIN G Pregabalin - 150mg 150mg Capsule 2,534,487 L.L
N06AB03 PMS-FLUOXETINE G Fluoxetine (HCl) - 20mg 20mg Capsule 592,635 L.L
J01CA04 AMOXIDREX G Amoxicillin (trihydrate) - 500mg 500mg Capsule 7,332,097 L.L
N03AX16 PREGAFORTE 150 G Pregabalin - 150mg 150mg Capsule 1,023,880 L.L
N06AB03 PROXETIN G Fluoxetine (HCl) - 20mg 20mg Capsule 374,996 L.L
J01CA04 AMOXYCILLIN G Amoxicillin (trihydrate) - 500mg 500mg Capsule 4,073,187 L.L
N06AB03 FLUTIN G Fluoxetine (HCl) - 20mg 20mg Capsule 362,837 L.L
J01CA04 MOXILEN G Amoxicillin (trihydrate) - 500mg 500mg Capsule 3,717,068 L.L
N03AX16 LYRICA B Pregabalin - 75mg 75mg Capsule 598,010 L.L
N03AX16 LYRICA B Pregabalin - 75mg 75mg Capsule 2,131,334 L.L
N03AX16 GABRIKA 75 G Pregabalin - 75mg 75mg Capsule 793,507 L.L
L01EA03 TASIGNA B Nilotinib - 200mg 200mg Capsule 395,037,357 L.L
N03AX16 GALICA 75 G Pregabalin - 75mg 75mg Capsule 338,648 L.L
L01EA03 TASIGNA B Nilotinib - 150mg 150mg Capsule 310,220,984 L.L
N03AX16 NERVAX G Pregabalin - 75mg 75mg Capsule 513,348 L.L
M01AE01 ADVIL LIQUI-GELS B Ibuprofen - 200mg 200mg Capsule 464,970 L.L
N03AX16 NEUREXAL G Pregabalin - 75mg 75mg Capsule 335,577 L.L
N03AX16 NEUREXAL G Pregabalin - 75mg 75mg Capsule 637,365 L.L
N03AX16 PLENICA G Pregabalin - 75mg 75mg Capsule 697,454 L.L
J01FA10 ZITHROMAX B Azithromycin (dihydrate) - 250mg 250mg Capsule 591,291 L.L
N03AX16 PMS-PREGABALIN G Pregabalin - 75mg 75mg Capsule 1,776,560 L.L
N03AX16 PREGAFORTE 75 G Pregabalin - 75mg 75mg Capsule 793,507 L.L
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