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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
A07EC02 PENTASA XTEND B Mesalazine - 2g 2g Granules for suspension 8,550,789 L.L
J01DB01 KEFLEX B Cefalexin (monohydrate) - 250mg/5ml 250mg/5ml Granules for suspension 477,384 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 250mg/5ml 250mg/5ml Granules for suspension 1,120,782 L.L
A07XA04 HIDRASEC INFANTS B Racecadotril - 10mg 10mg Granules for suspension 858,715 L.L
J01DC04 CECLOR B Cefaclor (monohydrate) - 250mg/5ml 250mg/5ml Granules for suspension 851,100 L.L
J01DC04 CECLOR B Cefaclor (monohydrate) - 125mg/5ml 125mg/5ml Granules for suspension 487,623 L.L
J02AC01 MYXEN G Fluconazole - 50mg/5ml 50mg/5ml Granules for suspension 793,507 L.L
R05CB01 TREBON N G Acetylcysteine - 600mg 600mg Granules for suspension 596,666 L.L
J01FA09 KLACID B Clarithromycin - 125mg/5ml 125mg/5ml Granules for suspension 575,165 L.L
J01FA09 KLACID B Clarithromycin - 250mg/5ml 250mg/5ml Granules for suspension 1,698,617 L.L
J01XX01 MONUROL B Fosfomycine (trométamol) - 3g 3g Granules for solution 571,133 L.L
J01XX01 FOSFOKEY G Fosfomycine (trométamol) - 3g 3g Granules for solution 399,121 L.L
J01XX01 FOSFOLAG G Fosfomycine (trométamol) - 3g 3g Granules for solution 399,121 L.L
N02BE51 REMIDOL G Paracetamol - 650mg, Dextromethorphan HBr - 20mg, Chlorphenamine maleate - 4mg Granules for solution 537,537 L.L
R03DC03 AIRFAST PEDIATRICS G Montelukast (sodium) - 4mg 4mg Granules for solution 880,217 L.L
R05CB01 EXOMUC B N-acetylcysteine - 200mg 200mg Granules for solution 588,603 L.L
R05X FERVEX CHILDREN SUGAR FREE B Paracetamol - 280mg, Ascorbic acid - 100mg, Pheniramine maleate - 10mg Granules for solution 425,998 L.L
R05X FERVEX ADULTS SUGAR FREE B Paracetamol - 500mg, Ascorbic acid - 200mg, Pheniramine maleate - 25mg Granules for solution 425,998 L.L
R05X FERVEX ADULTS RASPBERRY B Paracetamol - 500mg, Ascorbic acid - 200mg, Pheniramine maleate - 25mg Granules for solution 425,998 L.L
R05X FERVEX ADULTS B Paracetamol - 500mg, Ascorbic acid - 200mg, Pheniramine maleate - 25mg Granules for solution 425,998 L.L
A06AD04 EPSOM SALT G Magnesium sulfate - 40g 40g Granules 89,590 L.L
R03DC03 SINGULAIR PAEDIATRIC B Montelukast (sodium) - 4mg 4mg Granules 1,248,430 L.L
P01AB07 SECNOL G Secnidazole anhydre - 2g 2g Granules 842,589 L.L
P01AB07 SECNOL G Secnidazole - 2g 2g Granules 842,589 L.L
M01AB05 FLECTOR E.P B Diclofenac (epolamine) - 50mg 50mg Granules 503,941 L.L
G04B FONCITRIL 4000 B Citric acid - 1.189g, Potassium Citrate - 1.73g, Sodium citrate - 1.845g Granules 1,613,955 L.L
G04BC URALYT-U B Potassium Sodium Hydrogen Citrate - 2427.7mg 2427.7mg Granules 1,351,906 L.L
M02AA13 IBUSTICK G Ibuprofen - 50mg/g 50mg/g Gel, roll on 857,372 L.L
A01AB09 DAKTARIN ORAL B Miconazole nitrate - 20mg/g 20mg/g Gel 377,620 L.L
A01AB09 MICONAZ G Miconazole nitrate - 20mg/g 20mg/g Gel 229,093 L.L
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