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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
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 90,869 L.L
L01CE02 IRINOTECAN THYMOORGAN G Irinotecan HCl - 100mg/5ml 100mg/5ml Injectable concentrated solution 6,111,796 L.L
M01AB01 INDOMEL G Indometacin - 100mg 100mg Suppository 222,694 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 174,060 L.L
L01CE02 IRNOCAM 100 G Irinotecan HCl - 100mg/5ml 100mg/5ml Injectable solution 7,320,947 L.L
L01CE02 IRINOTECAN THYMOORGAN G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable concentrated solution 2,123,271 L.L
L01CE02 IRNOCAM 40 G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable solution 908,694 L.L
J01DH51 IMILASTIN G Imipenem - 500mg, Cilastatin - 500mg Injectable powder for solution 5,869,189 L.L
J01DH51 IMIPENEM-CILASTATIN LABATEC G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable powder for solution 8,922,845 L.L
J01DH51 IMIPENEME CILASTATINE PANPHARMA G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable powder for solution 10,840,366 L.L
N01AB06 ISOFLURANE HIKMA G Isoflurane - Volatil liquid 1,583,046 L.L
L01EA01 IMATINIB GP PHARM G Imatinib - 400mg 400mg Tablet, coated 26,083,945 L.L
L01EA01 IMATINIB NEAPOLIS G Imatinib - 400mg 400mg Tablet, film coated 36,046,335 L.L
L01EA01 IMATINIB SPC G Imatinib - 400mg 400mg Tablet, film coated 62,161,280 L.L
L01EA01 IMATINIB GP PHARM G Imatinib - 100mg 100mg Tablet, coated 26,083,945 L.L
L01EA01 IMATINIB NEAPOLIS G Imatinib - 100mg 100mg Tablet, film coated 31,085,276 L.L
L01EA01 IMATINIB NEAPOLIS G Imatinib - 100mg 100mg Tablet, film coated 16,360,672 L.L
C01DA08 ISDN G Isosorbide dinitrate - 10mg 10mg Tablet 311,771 L.L
L01EA01 IMATINIB SPC G Imatinib - 100mg 100mg Tablet, film coated 29,473,181 L.L
C01DA08 ISODEX G Isosorbide dinitrate - 10mg 10mg Tablet 138,224 L.L
A10BD11 INAGLIMET G Metformin - 1000mg, Linagliptin - 2.5mg Tablet, film coated 1,670,844 L.L
A10BD11 INAGLIMET G Metformin - 850mg, Linagliptin - 2.5mg Tablet, film coated 1,670,844 L.L
P02CF01 IVERMECTINE BIOGARAN G Ivermectin - 3mg 3mg Tablet 1,075,074 L.L
P02CF01 IVER G Ivermectin - 6mg 6mg Tablet 431,373 L.L
N05CD08 IPNODIS MEDIS G Midazolam - 5mg/ml 5mg/ml Injectable solution 565,758 L.L
P02CF01 IVERMECTIN BENTA G Ivermectin - 6mg 6mg Tablet 784,548 L.L
P02CF01 IVERMECTIN BENTA G Ivermectin - 6mg 6mg Tablet 470,985 L.L
N05CF04 INDUCTAL G Eszopiclone - 2mg 2mg Tablet, film coated 1,411,035 L.L
N05CF04 INDUCTAL G Eszopiclone - 3mg 3mg Tablet, film coated 1,693,242 L.L
C01EB17 IVABRADINE ARROW G Ivabradine (HCl) - 5mg 5mg Tablet, film coated, scored 1,323,685 L.L
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