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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
J01DH51 CELLABAXIN G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable solution 10,699,559 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE SG G Potassium chloride - 3.92g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 8.99g/l, Sodium acetate, 3H2O - 166.7g/l, Sodium chloride - 214.76g/l Injectable solution L.L
J01DH51 CILANEM G Imipenem anhydrous - 500mg, Cilastatin (sodium) - 500mg Injectable solution 850,652 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS L G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:106.5 mmol/l, Sodium chloride - Na+:135 mmol/l Injectable solution L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LM G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:111.5 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS2 G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.5 mmol/l, Sodium acetate - Cl-:111 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS3 G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.60 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
N01BB02 CHLORHYDRATE DE LIDOCAINE RENAUDIN G Lidocaine (HCl) - 10mg/ml 1% Injectable solution 591,291 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS R G Potassium chloride - K+:1.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.40 mmol/l, Sodium acetate - Cl-:105.8 mmol/l, Sodium chloride - Na+:140.5 mmol/l Injectable solution L.L
B05ZA CONCENTRATE SOLUTIONFOR HEMODIALYSIS TYPE A G Hemodialytics, concentrates - Injectable solution L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE B+ G Hemodialytics, concentrates - Injectable solution L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE J G Hemodialytics, concentrates - Injectable solution L.L
G03GA05 CINNAL-f BioHuman Follitropin alfa - 900IU/1.5ml 900IU/1.5ml Injectable solution 14,826,544 L.L
A03FA01 CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 530,818 L.L
G03GA05 CINNAL-f BioHuman Follitropin alfa - 450IU/0.75ml 450IU/0.75ml Injectable solution 7,372,177 L.L
N02AA01 CHLORHYDRATE DE MORPHINE RENAUDIN G Morphine HCl - 20mg/ml 20mg/ml Injectable solution 1,100,607 L.L
J06BA02 CLAIRYG BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution 40,685,649 L.L
J06BA02 CLAIRYG BioHuman Human normal immunoglobulin G - 50mg/ml 10g/200ml Injectable solution 74,469,269 L.L
J06BA02 CUVITRU BioHuman Human normal immunoglobulin - 4g/20ml 200mg/ml Injectable solution 29,806,627 L.L
J06BA02 CUVITRU BioHuman Human normal immunoglobulin - 8g/40ml 200mg/ml Injectable solution 53,593,818 L.L
J01FF01 CLINDAMYCIN VIANEX BA FREE G Clindamycin (phosphate) - 600mg/4ml 600mg/4ml Injectable solution 201,576 L.L
J01FF01 CLINDAMYCIN-HAMELN G Clindamycin (phosphate) - 600mg/4ml 150mg/ml Injectable solution 3,535,650 L.L
C01EB10 CARDESINE G Adenosine - 6mg/2ml 6mg/2ml Injectable solution 563,070 L.L
L03AB07 CINNOVEX BioTech Interferon beta-1a - 30mcg 30mcg Injectable solution 39,804,728 L.L
J06BA02 CLAIRYG BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution L.L
J01MA02 CIPROFLOXACINE PANPHARMA G Ciprofloxacine (HCl) - 200mg/100ml 200mg/100ml Injectable solution 5,120,040 L.L
J01MA02 CIPROFLOXACINE PANPHARMA G Ciprofloxacine (HCl) - 200mg/100ml 200mg/100ml Injectable solution 5,120,040 L.L
L01FG02 CYRAMZA BioTech Ramucirumab - 500mg/50ml 500mg/50ml Injectable solution L.L
J01MA02 CIPROFLOXACINE PANPHARMA G Ciprofloxacin - 200mg/100ml 200mg/100ml Injectable solution 4,914,432 L.L
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