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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
V03AB14 PROSULF 1% B Protamine sulfate - 50mg/5ml 1% Injectable solution 8,216,459 L.L
B01AA07 SINTROM B Acenocoumarol - 4mg 4mg Tablet 490,183 L.L
C07FB07 CONCOR AM 2.5 B Bisoprolol fumarate - 2.5mg, Amlodipine besylate - 5mg Tablet, film coated 1,324,559 L.L
G03CA03 OESTRODOSE B Estradiol (17 bêta estradiol anhydre) - 0.06% 0.06% Gel 642,357 L.L
J05AB11 VALTREX B Valaciclovir - 500mg 500mg Tablet, film coated 4,481,715 L.L
L01XG02 KYPROLIS B Carfilzomib - 60mg 60mg Injectable powder for solution 96,642,005 L.L
M01AB01 INDOCID B Indometacin - 100mg 100mg Suppository 424,910 L.L
M05BA08 ZOMETA B Zoledronic acid (monohydrate) - 4mg/5ml 4mg/5ml Injectable concentrated solution 13,697,658 L.L
N03AX11 TOPAMAX 25 B Topiramate - 25mg 25mg Tablet, film coated 858,715 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 150mg 150mg Injectable suspension, prolonged release 26,434,190 L.L
V03AB35 BRIDION B Sugammadex - 100mg/ml 100mg/ml Injectable solution 54,230,830 L.L
C07FB07 CONCOR AM 5 B Bisoprolol fumarate - 5mg, Amlodipine besylate - 5mg Tablet, film coated 1,324,559 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 25mcg 25mcg Tablet, scored 256,674 L.L
L01XG03 NINLARO B Ixazomib - 4mg 4mg Capsule, hard 388,991,058 L.L
N05AX13 TREVICTA B Paliperidone - 175mg 175mg Injectable suspension, prolonged release 33,673,469 L.L
C08CA01 AMLOR B Amlodipine besylate - 5mg 5mg Capsule 560,382 L.L
G03CA03 ESTROFEM B Estradiol (hemihydrate) - 2mg 2mg Tablet, film coated 399,121 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 50mcg 50mcg Tablet, scored 391,058 L.L
J01DH02 MERONEM B Meropenem (trihydrate) - 500mg 500mg Injectable powder for solution 10,398,061 L.L
L01CD04 JEVTANA INJECTION B Cabazitaxel - 60mg/1.5ml 60mg/1.5ml Injectable dry powder for solution+diluent 75,619,931 L.L
L01XG03 NINLARO B Ixazomib - 3mg 3mg Capsule, hard 348,420,676 L.L
N05AX13 TREVICTA B Paliperidone - 263mg 263mg Injectable suspension, prolonged release 39,162,480 L.L
A03CA02 LIBRAX DRAGEES B Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet, sugar coated 435,405 L.L
A10BB09 DIAMICRON MR B Gliclazide - 60mg 60mg Tablet, modified release 382,995 L.L
C08CA01 AMLOR B Amlodipine besylate - 5mg 5mg Capsule 560,382 L.L
C09DB02 SEVIKAR B Olmesartan medoxomil - 20mg, Amlodipine - 5mg Tablet, film coated 1,019,976 L.L
H03AA01 ELTROXIN B Levothyroxine sodium - 100mcg 100mcg Tablet, scored 440,780 L.L
L01CD04 JEVTANA INJECTION B Cabazitaxel - 60mg/1.5ml 60mg/1.5ml Injectable dry powder for solution+diluent 75,619,931 L.L
L01XG03 NINLARO B Ixazomib - 2.3mg 2.3mg Capsule, hard 272,619,919 L.L
N03AX11 TOPAMAX B Topiramate - 50mg 50mg Tablet, film coated 1,914,976 L.L
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