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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
P01AB01 METROGYL G Metronidazole benzoate - 200mg/5ml 200mg/5ml Powder for suspension 481,788 L.L
R05DB13 RAPICOD G Butamirate citrate - 0.15% 0.15% Syrup 296,989 L.L
A04AA01 ONDANSETRON RENAUDIN G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 4,345,987 L.L
B01AC04 PEDOVEX G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 808,993 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C01CA03 NORADRENALINE NOREPINEPHRINE (tartrate) Aguettant G Norepinephrine tartrate - 2mg/ml 2mg/ml Injectable solution 1,896,162 L.L
G03DA04 GESTA 400 G Progesterone - 400mg 400mg Pessary 1,083,137 L.L
J01AA02 DOXYLAG G Doxycycline (HCl) - 100mg 100mg Capsule 174,700 L.L
J01DH02 MEROZAN G Meropenem - 1g 1g Injectable powder for solution 6,443,725 L.L
J05AF10 ENTECAVIR ARROW G Entecavir - 1mg 1mg Tablet, coated 18,701,506 L.L
L01DB01 DOXO-CELL G Doxorubicin HCl - 50mg/25ml 50mg/25ml Injectable solution 1,794,030 L.L
L01XX05 UNIDREA G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule, hard 2,539,862 L.L
M01AB05 EPARDEX G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 223,974 L.L
M05BA08 ZOLEDRONIC ACID HIKMA G Zoledronic acid (monohydrate) - 4mg/5ml 4mg/5ml Injectable concentrate for solution 9,098,466 L.L
N03AX11 TOPIRATE 25 BENTA G Topiramate - 25mg 25mg Tablet, film coated 671,921 L.L
P01AB01 METRIS G Metronidazole - 500mg/100ml 0.5% Injectable solution 142,447 L.L
R05DB13 TUSSIN G Butamirate citrate - 7.5mg/5ml 7.5mg/5ml Syrup, sugar free 296,925 L.L
A04AA01 ONDANSETRON VIANEX G Ondansetron (HCl) - 8mg/4ml 8mg/4ml Injectable solution 387,027 L.L
B01AC04 PIDOGREL MEDIS G Clopidogrel - 75mg 75mg Tablet, film coated 810,337 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 217,210 L.L
C01CA03 NORADRENALINE RENAUDIN G Norepinephrine tartrate - 8mg/4ml 0.2% Injectable solution 2,000,981 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,067,011 L.L
D06AX DERMOTRACIN G Neomycin sulfate - 165.000IU/150ml, Bacitracin - 15.500IU/150ml Powder 737,770 L.L
J01AA02 FARMODOXI G Doxycycline (hyclate) - 100mg 100mg Tablet 310,428 L.L
J01DH02 MIRAN G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 819,744 L.L
J05AF10 ENTECAVIR BIOGARAN G Entecavir - 1mg 1mg Tablet, coated 19,080,319 L.L
L01DB01 DOXORUBICINA TEDEC G Doxorubicin HCl - 50mg/25ml 50mg/25ml Injectable concentrate for solution 2,015,764 L.L
M01AB05 EPARDEX G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 3,246,979 L.L
N03AX11 TORAMAT G Topiramate - 25mg 25mg Tablet, film coated 522,755 L.L
P01AB01 METRONIDAZOLE G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 162,605 L.L
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