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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
J07BD52 M-M-R II (MEASLES, MUMPS AND RUBELLA VIRUS VACCINE LIVE) B Rubella virus live attenuated - , Mumps virus live attenuated - , Measles virus live attenuated - Injectable solution+diluent 12,924,401 L.L
A02AF02 MAALOX PLUS B Dimethicone - 25mg, Aluminium hydroxide - 200mg, Magnesium hydroxide - 200mg Tablet, chewable 166,636 L.L
A02AF02 MAALOX PLUS B Simethicone - 25mg/5ml, Aluminium hydroxide - 175mg/5ml, Magnesium hydroxide - 200mg/5ml Suspension 438,093 L.L
L01FA01 MABIXEN 100 BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 22,183,393 L.L
L01FA01 MABIXEN 100 BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 11,091,696 L.L
L01FA01 MABIXEN 500 BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 136,761,210 L.L
L01FA01 MABIXEN 500 BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 74,718,320 L.L
N02AX02 MABRON G Tramadol HCl - 100mg/2ml 100mg/2ml Injectable solution 146,479 L.L
L01FA01 MABTHERA BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrated solution 35,722,424 L.L
L01FA01 MABTHERA BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrated solution 80,211,932 L.L
L01FD01 MABTIN 440 BioTech Trastuzumab (r-DNA origin) - 440mg 440mg Injectable powder for solution 70,042,700 L.L
M05BA07 MADRONATE G Risedronate sodium - 35mg 35mg Tablet, film coated 724,907 L.L
J01DD08 MAGNACEF G Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 349,399 L.L
J01DD08 MAGNACEF G Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 700,142 L.L
J01DD08 MAGNACEF 400 G Cefixime - 400mg 400mg Capsule 1,307,559 L.L
A12CC MAGNE B6 B Pyridoxine HCl - 5mg, Magnesium lactate dihydrate - 470mg Tablet, coated 365,525 L.L
A12CC MAGNE B6 B Pyridoxine HCl - 5mg, Magnesium lactate dihydrate - 470mg Tablet, coated 365,525 L.L
B05XA05 MAGNESIUM SULFATE G Magnesium sulfate, 7H2O - 15g/100ml 15g/100ml Injectable solution 756,160 L.L
B05XA05 MAGNESIUM SULFATE G Magnesium sulfate, 7H2O - 50g/100ml 50g/100ml Injectable solution 897,510 L.L
B05XA05 MAGNESIUM SULFATE G Magnesium sulfate, 7H2O - 10g/100ml 10g/100ml Injectable solution 5,040,303 L.L
N02BE01 MAKOACHE G Paracetamol - 1000mg/100ml 10mg/ml Injectable solution 1,403,867 L.L
B03AD04 MALTOFER B Iron trivalent (hydroxide polymaltose) - 10mg/ml 50mg/5ml Syrup 589,947 L.L
B03AD04 MALTOFER B Iron trivalent (hydroxide polymaltose) - 10mg/ml 50mg/5ml Syrup 589,947 L.L
B03AD04 MALTOFER B Iron trivalent (hydroxide polymaltose) - 50mg/ml 50mg/ml Drops solution 649,076 L.L
B03AD04 MALTOFER B Iron trivalent (hydroxide polymaltose) - 50mg/ml 50mg/ml Drops solution 649,076 L.L
B03AD MALTOFER FOL B Folic acid - 0.35mg, Iron trivalent (hydroxide polymaltose) - 100mg Tablet, chewable 854,684 L.L
N05AN01 MANICARB SR-400 G Lithium carbonate - 400mg 400mg Tablet, prolonged release 1,431,192 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 406,810 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 579,064 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 613,662 L.L
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