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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
J01CR02 AMOCLAN FORTE G Amoxicillin (trihydrate) - 500mg, Clavulanic Acid (potassium) - 125mg 625mg Tablet 170,668 L.L
J01MA01 OFLACIN G Ofloxacin - 200mg 200mg Tablet, film-scored 602,041 L.L
M01AE01 IBUPROFEN B. BRAUN G Ibuprofen - 600mg/100ml 600mg/100ml Injectable solution 550,975 L.L
N02AJ13 MOLCET G Paracetamol - 325mg, Tramadol - 37.5mg Tablet 317,403 L.L
N06AB06 SOLOTIK G Sertraline HCl - 100mg 100mg Tablet, film coated 616,824 L.L
R02A TRACHISAN G Lidocaine HCl - 1mg, Tyrothricin - 0.5mg, Chlorhexidine gluconate - 1mg Lozenge 228,453 L.L
R06AX26 EXOFEN G Fexofenadine HCl - 180mg 180mg Tablet, film coated 287,582 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 150mg 150mg Capsule, hard 2,576,338 L.L
B05BC01 MANNITOL G Mannitol - 10g/100ml 10g/100ml Injectable solution 494,147 L.L
C10AA05 TARDELIP G Atorvastatin - 10mg 10mg Tablet, film coated 688,559 L.L
D07AC13 KONEX G Mometasone furoate - 0.1% 0.1% Solution 385,683 L.L
G04BE03 VONTA G Sildenafil citrate - 50mg 50mg Tablet, film coated 335,961 L.L
J01CR02 CURAM G Amoxicillin (trihydrate) - 500mg, Clavulanic Acid (potassium) - 125mg 625mg Tablet, film coated 386,869 L.L
J01MA01 OFLOMED G Ofloxacin - 200mg 200mg Tablet, film-scored 601,530 L.L
J07AH MENFIVE G Meningococcal (serogroups A, C, Y, W, X) Polysaccharide conjugate vaccine - Injectable freeze dried powder + diluent 3,527,587 L.L
L01EF01 PALBRANCE 75 G Palbociclib - 75mg 75mg Capsule 168,011,222 L.L
N02AJ13 TRAMADOL/PARACETAMOL ARROW LAB G Tramadol - 37.5mg, Paracetamol - 325mg Tablet, coated 205,608 L.L
N06AB06 SERTRALINE BIOGARAN G Sertraline HCl - 25mg 25mg Capsule 130,353 L.L
R02A CHLORASEPTIC TOTAL SORE THROAT + COUGH LOZENGES WILD CHERRY G Benzocaine - 6mg, Dextromethorphan - 5mg, Menthol - 10mg Lozenge 537,537 L.L
R06AX26 FENADEX 180 G Fexofenadine HCl - 180mg 180mg Tablet, coated 295,645 L.L
A06AB02 SUPPOLAX G Bisacodyl - 10mg 10mg Suppository 575,270 L.L
B05BC01 MANNITOL 10% USP INJECTION G Mannitol - 10% 10% Injectable solution 430,943 L.L
C10AA05 TARDEN G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 688,559 L.L
D07AC13 METASONE G Mometasone furoate - 0.1% 0.1% Lotion 239,332 L.L
G04BE03 VONTA G Sildenafil citrate - 50mg 50mg Tablet, film coated 90,037 L.L
J01CR02 JULMENTIN FORTE G Amoxicillin (trihydrate) - 500mg, Clavulanic Acid (potassium) - 125mg 625mg Tablet, film coated 245,923 L.L
L01EF01 PAPILLIO G Palbociclib - 75mg 75mg Capsule, hard 147,883,080 L.L
M01AE02 NOPAIN DS G Naproxen (sodium) - 500mg 500mg Tablet, film coated 235,172 L.L
N03AX18 LACOSAMIDE/GENEPHARM G Lacosamide - 200mg 200mg Tablet 8,284,105 L.L
R02AA05 GOLASEPTINE-LIDOCAINE G Chlorhexidine HCl - 5mg, Lidocaine HCl - 1mg Tablet, chewable 736,426 L.L
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