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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
D06AX01 FUTASOLE G Fusidic acid - 20mg/g 2% Cream 145,135 L.L
J01AA12 TEGADIS G Tigecycline - 50mg 50mg Injectable powder for solution 2,418,917 L.L
J01EE01 PAEDIATRIC CO-TRIMOXAZOLE MIXTURE G Trimethoprim - 40mg/5ml, Sulfamethoxazole - 200mg/5ml Suspension 190,698 L.L
L01EA01 IMATINIB NEAPOLIS G Imatinib - 400mg 400mg Tablet, film coated 36,046,335 L.L
M01AB05 ALMIRAL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 415,247 L.L
N01AH01 FENTANYL PANPHARMA G Fentanyl - 0.1mg/2ml 0.1mg/2ml Injectable solution 1,101,951 L.L
N03AX12 NEUROPLEX G Gabapentin - 300mg 300mg Capsule 1,107,326 L.L
N05BA02 PSICODEX G Chlordiazepoxide - 5mg 5mg Tablet 152,302 L.L
P01AB07 SNAD G Secnidazole - 500mg 500mg Tablet 774,053 L.L
R05X COLDIN G Glyceryl guaiacolate - 15mg/5ml, Pseudoephedrine HCl - 15mg/5ml, Pyrilamine maleate - 6.25mg/5ml, Paracetamol - 120mg/5ml Syrup 386,515 L.L
A04AA01 JAMP ONDANSETRON G Ondansetron (HCl dihydrate) - 4mg/5ml 4mg/5ml Solution 2,687,685 L.L
A10BD07 SITAVITEA G Metformin - 850mg, Sitagliptin - 50mg Tablet, film coated 1,079,106 L.L
B01AC06 ASPICOT G Acetylsalicylic acid - 81mg 81mg Tablet, enteric coated 353,239 L.L
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 211,449 L.L
C01CA24 ADRENALINE RENAUDIN G Epinephrine (tartrate) - 1mg/ml 1mg Injectable solution 444,812 L.L
C09AA01 CAPTOPRIL G Captopril - 25mg 25mg Tablet, scored 4,453,878 L.L
D06AX01 ZETA G Fusidic acid - 20mg/g 20mg/g Cream 178,731 L.L
J01BA01 CHLORAMPHENICOL PALMITATE G Chloramphenicol (palmitate) - 125mg/5ml 125mg/5ml Suspension 159,981 L.L
L01EA01 IMATINIB SPC G Imatinib - 400mg 400mg Tablet, film coated 62,161,280 L.L
M01AB05 CLOFEN G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 299,677 L.L
N01AH01 FENTANYL HAMELN G Fentanyl (citrate) - 0.5mg/10ml 0.5mg/10ml Injectable solution 1,206,771 L.L
N03AX12 PMS-GABAPENTIN G Gabapentin - 300mg 300mg Capsule 869,466 L.L
N05BA06 LORAZEPAM G Lorazepam - 1mg 1mg Tablet, scored 325,082 L.L
P01AB07 SECNOL G Secnidazole anhydre - 2g 2g Granules 842,589 L.L
R05X COLD-MED G Glyceryl guaiacolate - 15mg/5ml, Pseudoephedrine HCl - 15mg/5ml, Pyrilamine maleate - 6.25mg/5ml, Paracetamol - 120mg/5ml Syrup 386,515 L.L
V03AC03 DEFERASIROX ARROW G Deferasirox - 360mg 360mg Tablet 18,379,327 L.L
A04AA01 NAUSETRON G Ondansetron - 4mg/5ml 4mg/5ml Solution 958,608 L.L
A10BD07 ZERILUX G Sitagliptin - 25mg/ml 25mg/ml Solution 1,127,529 L.L
B01AC06 ASPROTHIN G Acetylsalicylic acid - 81mg 81mg Tablet, enteric coated 148,463 L.L
B05BB02 2.5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 2.5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 172,377 L.L
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