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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
N06AB06 PMS-SERTRALINE G Sertraline HCl - 100mg 100mg Capsule 2,015,764 L.L
G04BE08 POTENZA G Tadalafil - 20mg 20mg Tablet, film coated 2,167,329 L.L
L01EF01 PAPILLIO G Palbociclib - 125mg 125mg Capsule, hard 147,883,080 L.L
L01EF01 PAPILLIO G Palbociclib - 125mg 125mg Capsule, hard L.L
J01CR05 PIPERACILINA/TAZOBACTAM SALA G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 913,813 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM PANPHARMA G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 8,851,296 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM SANDOZ G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 913,813 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM STRAGEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 897,687 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM STRAGEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 7,820,986 L.L
J01CR05 PIPTAZ-ORBUCELL G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 1,087,873 L.L
J01CR05 PRIZMA G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 913,813 L.L
N06AB10 PRAMACYT 10 G Escitalopram (oxalate) - 10mg 10mg Tablet, film coated 767,910 L.L
N06AB10 PRYLEX 10 G Escitalopram (oxalate) - 10mg 10mg Tablet, film coated 767,910 L.L
N06AB10 PRAMACYT 15 G Escitalopram (oxalate) - 15mg 15mg Tablet, film coated 921,492 L.L
N06AB10 PRYLEX 15 G Escitalopram (oxalate) - 15mg 15mg Tablet, film coated 921,492 L.L
R03AK06 PROPIONATE DE FLUTICASONE/ SALMETEROL ARROW G Salmeterol - 50mcg/dose, Fluticasone propionate - 100mcg/dose Inhalation powder 1,593,797 L.L
J01MA12 PILOQ G Levofloxacin - 500mg/100ml 500mg/100ml Injectable solution 980,365 L.L
R03AK06 PROPIONATE DE FLUTICASONE/ SALMETEROL ARROW G Salmeterol - 50mcg/dose, Fluticasone propionate - 250mcg/dose Inhalation powder 1,980,824 L.L
N06AB10 PRAMACYT 20 G Escitalopram (oxalate) - 20mg 20mg Tablet, film coated 972,686 L.L
N06AB10 PRYLEX 20 G Escitalopram (oxalate) - 20mg 20mg Tablet, film coated 972,686 L.L
A02BC02 PANTO TAD G Pantoprazole (sodium) - 40mg 40mg Tablet, gastroresistant 470,345 L.L
C04AD03 PENTOXIFYLLINE SR G Pentoxifylline - 1160 400mg Tablet, sustained release 1,478,227 L.L
R03AK06 PROPIONATE DE FLUTICASONE/ SALMETEROL ARROW G Salmeterol - 50mcg/dose, Fluticasone propionate - 500mcg/dose Inhalation powder 2,605,711 L.L
A02BC02 PANTOMAX G Pantoprazole (sodium sesquihydrate) - 40mg 40mg Tablet, enteric coated 771,366 L.L
L04AA27 PMS-FINGOLIMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 19,351,580 L.L
M01AE51 PROFINAL XP G Ibuprofen - 400mg, Caffeine - 65mg Caplet, film coated 286,238 L.L
A02BC02 PANTOMAX G Pantoprazole (sodium sesquihydrate) - 40mg 40mg Tablet, enteric coated 1,381,470 L.L
N04BC05 PRAMIPEXOLE BIOGARAN G Pramipexole (dihydrochloride monohydrate) - 0.18mg 0.18mg Tablet 440,780 L.L
N06AB10 PRAMACYT 5 G Escitalopram (oxalate) - 5mg 5mg Tablet, film coated 895,895 L.L
A02BC02 PANTOVER G Pantoprazole (sodium sesquihydrate) - 40mg 40mg Tablet, enteric coated 739,113 L.L
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