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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
B01AC04 PIDOGREL MEDIS G Clopidogrel - 75mg 75mg Tablet, film coated 810,337 L.L
C09DX03 VOCADO HCT B Olmesartan medoxomil - 20mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,482,258 L.L
J05AF10 ENTRILIV G Entecavir - 0.5mg 0.5mg Tablet, film coated 19,165,898 L.L
M01AB05 DICLOGESIC RETARD G Diclofenac sodium - 100mg 100mg Tablet, film coated 233,829 L.L
N05AX16 REXULTI B Brexpiprazole - 3mg 3mg Tablet, film coated 13,433,051 L.L
A10BD07 SAGIMET G Metformin HCl - 500mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,432,536 L.L
B01AC04 PLAVINOR-75 G Clopidogrel - 75mg Tablet, film coated Tablet, film coated 1,112,702 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 20mg, Amlodipine (besylate) - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,037,446 L.L
J01AA08 VULGA XR G Minocycline - 105mg 105mg Tablet, film coated 3,682,128 L.L
J05AF10 HEPCAVIR 0.5 G Entecavir monohydrate - 0.5mg 0.5mg Tablet, film coated 18,998,515 L.L
N05AX16 REXULTI B Brexpiprazole - 2mg 2mg Tablet, film coated 13,433,051 L.L
B01AC04 THROMBO G Clopidogrel - 75mg 75mg Tablet, film coated 764,646 L.L
C09DX03 VOCADO HCT B Olmesartan medoxomil - 40mg, Amlodipine - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,523,917 L.L
J01AA08 VULGA XR G Minocycline - 80mg 80mg Tablet, film coated 2,832,820 L.L
J05AF13 VEMLIDY B Tenofovir alafenamide fumarate - 25mg 25mg Tablet, film coated 25,968,918 L.L
L01XX74 WELIREG B Belzutifan - 40mg 40mg Tablet, film coated 1,550,772,301 L.L
N05AX16 REXULTI B Brexpiprazole - 1mg 1mg Tablet, film coated 13,433,051 L.L
P01AB01 FLAGYL B Metronidazole - 250mg 250mg Tablet, film coated 176,043 L.L
V03AC03 DEFEROXAL 90 G Deferasirox - 90mg 90mg Tablet, film coated 9,279,724 L.L
B01AC04 TROKEN G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,148,985 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,067,011 L.L
J01AA08 VULGA XR G Minocycline - 55mg 55mg Tablet, film coated 1,983,512 L.L
L01EA01 CEMIVIL G Imatinib - 400mg 400mg Tablet, film coated 41,106,321 L.L
M01AB05 TRATUL RETARD G Diclofenac Sodium - 100mg 100mg Tablet, film coated 866,778 L.L
V03AC03 JADENU B Deferasirox - 180mg 180mg Tablet, film coated 34,062,918 L.L
C09DX03 VOCADO HCT B Olmesartan medoxomil - 40mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,523,917 L.L
J05AG03 STOVIRENZ G Efavirenz - 600mg 600mg Tablet, film coated 6,857,456 L.L
L01EA01 GLIMATINIB BENTA 400 G Imatinib (mesylate) - 400mg 400mg Tablet, film coated 38,254,090 L.L
A10BD07 SAGIMET G Metformin HCl - 850mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,463,892 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,067,011 L.L
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