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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
J02AC01 PANZIMOL G Fluconazole - 100mg 100mg Capsule, hard 2,015,764 L.L
C07AB07 PRESCOR 10 G Bisoprolol - 10mg 10mg Tablet, film coated 460,746 L.L
A03AX12 PHLOROGLUCINOL/TRIMETHYLPHLOROGLUCINOL ARROW G Phloroglucinol - 40mg/4ml, Trimethylphloroglucinol - 0.04mg/4ml Injectable solution 940,690 L.L
M03BB53 PARAXONE-JPI G Paracetamol - 300mg, Chlorzoxazone - 250mg Capsule 334,617 L.L
N02BE71 PYRETHAL G Paracetamol - 200mg, Phenobarbital - 20mg Suppository 147,183 L.L
J02AC01 PANZIMOL G Fluconazole - 150mg 150mg Capsule, hard 428,686 L.L
A12CX PHOSPHATE DIPOTASSIQUE RENAUDIN G Phosphate dipotassique - 174.20mg/ml 174.20mg/ml Injectable solution 1,189,301 L.L
A13A POTENCIATOR G Arginine Aspartate - 5g/10ml 5g Solution 1,402,972 L.L
S01FB01 PHENYLEPHRINE/ COOPER G Phenylephrine HCl - 10% 10% Drops solution 278,175 L.L
N05AX08 PMS-RISPERIDONE G Risperidone - 1mg 1mg Tablet 823,775 L.L
N05AX08 PMS-RISPERIDONE G Risperidone - 1mg/ml 1mg/ml Solution 604,729 L.L
R05C PULMONAL SIROP G Belladona tincture - 0.5g/5ml, Drosera tincture - 2g/5ml, Ammonium bromide - 2g/5ml, Sodium benzoate - 2g/5ml Syrup 148,463 L.L
C09DB01 POVAM G Amlodipine (besylate) - 5mg, Valsartan - 160mg Tablet, film coated 857,372 L.L
G02CB03 PROCTIN G Cabergoline - 0.5mg 0.5mg Tablet 350,679 L.L
H02AB06 PEDIACORT G Prednisolone sodium phosphate - 15mg/5ml 15mg/5ml Solution 417231.1 L.L
A03CA02 PRIMAX G Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet 222,694 L.L
G02CB03 PROCTIN G Cabergoline - 0.5mg 0.5mg Tablet 1,300,328 L.L
H02AB06 PREDALONE G Prednisolone - 15mg/5ml 15mg/5ml Syrup 890,776 L.L
L01CD01 PACLITAXEL MYLAN PHARMA 6MG/ML G Paclitaxel - 300mg/50ml 300mg/50ml Injectable concentrated powder for solution 50,777,144 L.L
C07BB07 PRESCOR 5 PLUS G Bisoprolol - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 678,321 L.L
G02CB03 PROCTINMED G Cabergoline - 0.5mg 0.5mg Tablet 473,545 L.L
H02AB06 PREDO G Prednisolone sodium phosphate - 15mg/5ml 15mg/5ml Syrup 1,018,633 L.L
L01CD01 PATAXEL G Paclitaxel - 300mg/50ml 300mg/50ml Injectable concentrate for solution 17,809,220 L.L
N03AB02 PHENTOLEP INJECTION G Phenytoin (sodium) - 250mg/5ml 250mg/5ml Injectable solution 1,447,318 L.L
N05AX08 PMS-RISPERIDONE G Risperidone - 2mg 2mg Tablet 931,283 L.L
G02CB03 PROCTINMED G Cabergoline - 0.5mg 0.5mg Tablet 1,689,402 L.L
H02AB06 PREDOXONE G Prednisolone sodium phosphate - 15mg/5ml 15mg/5ml Solution 417,231 L.L
L01CD01 PACLITAXEL MYLAN PHARMA 6MG/ML G Paclitaxel - 30mg/5ml 30mg/5ml Injectable concentrated powder for solution 5,698,047 L.L
H02AB07 PREDICOR G Prednisone - 5mg 5mg Tablet, scored 174,060 L.L
L01CD01 PACLITAXEL NEAPOLIS G Paclitaxel - 30mg 30mg Injectable concentrate for solution 3,514,148 L.L
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