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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
N02BE51 PARACETAMOL/CAFEINE/CODEINE BIOGARAN Paracetamol - 400mg, Caffeine - 50mg, Codeine - 20mg 548,288 L.L
D06AX TRIPLE ANTIBIOTIC ORIGINAL OINTMENT Bacitracin - 400U, Neomycin (sulfate) - 3.5mg, Polymyxin B (sulfate) - 5000U 580,540 L.L
J01CR05 PIPERACILLINE/ TAZOBACTAM ARROW Piperacillin (sodium) - 4g, Tazobactam (sodium) - 500mg 7,378,682 L.L
J01CR05 TAZOBACT Piperacillin sodium - 4g, Tazobactam (sodium) - 500mg 783,460 L.L
C03CA02 BURINEX B Bumetanide - 1mg 1mg Tablet 201,576 L.L
L01AA09 RIBOMUSTIN B Bendamustine HCl - 100mg 100mg Injectable powder for concentrate for solution 31,939,807 L.L
L01EX08 LENVIMA B Lenvatinib - 4mg 4mg Capsule, hard 120,133,345 L.L
N05AH03 ZYPREXA B Olanzapine - 5mg 5mg Tablet 1,197,364 L.L
N06BA04 RITALIN B Methylphenidate HCl - 10mg 10mg Tablet 376,276 L.L
R03BA05 FLIXOTIDE EVOHALER B Fluticasone propionate - 50mcg/actuation 50mcg/actuation Inhalation suspension 671,921 L.L
A01AB09 DAKTARIN ORAL B Miconazole nitrate - 20mg/g 20mg/g Gel 377,620 L.L
A06AX05 RESOLOR B Prucalopride succinate - 2mg 2mg Tablet, film coated 5,251,736 L.L
C03CA02 BURINEX B Bumetanide - 5mg 5mg Tablet 1,054,916 L.L
G04BE09 LEVITRA B Vardenafil (HCl) - 20mg 20mg Tablet, film coated 2,660,808 L.L
L01EX08 LENVIMA B Lenvatinib - 10mg 10mg Capsule, hard 120,133,345 L.L
N05AH03 ZYPREXA B Olanzapine - 5mg 5mg Tablet 1,197,364 L.L
N06BA04 CONCERTA B Methylphenidate HCl - 27mg 27mg Tablet, extended release 4,393,021 L.L
R03BB01 ATROVENT B Ipratropium bromide - 250mcg/2ml 250mcg/2ml Inhaltion solution with nebuliser 544,256 L.L
S01CA01 FRAKIDEX B Dexamethasone disodium phosphate - 0.1g/100g, Framycetin sulfate - 0.5g/100g Ointment 141,103 L.L
A10BH03 ONGLYZA B Saxagliptin HCl - 2.5mg 2.5mg Tablet 1,987,543 L.L
B01AX05 ARIXTRA B Fondaparinux sodium - 2.5mg/0.5ml 2.5mg/0.5ml Injectable solution 5,341,774 L.L
C03DA01 ALDACTONE B Spironolactone - 100mg 100mg Tablet 458,250 L.L
C09CA04 APROVEL B Irbesartan - 150mg 150mg Tablet, film coated 651,764 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 500mg 500mg Tablet, film coated 877,085 L.L
L01EX09 OFEV B Nintedanib - 100mg 100mg Capsule, soft 100,972,184 L.L
N02BE01 CHILDREN'S PANADOL 5-12 YEARS B Paracetamol - 240mg/5ml 240mg/5ml Elixir 356,118 L.L
N06BA04 CONCERTA B Methylphenidate HCl - 36mg 36mg Tablet, extended release 4,393,021 L.L
R03BB01 ATROVENT B Ipratropium bromide - 500mcg/2ml 500mcg/2ml Inhaltion solution with nebuliser 713,580 L.L
A06AX05 RESOLOR B Prucalopride succinate - 1mg 1mg Tablet, film coated 3,273,600 L.L
A10BH03 ONGLYZA B Saxagliptin HCl - 5mg 5mg Tablet 3,836,670 L.L
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