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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
R05DB13 TUSSIN G Butamirate citrate - 7.5mg/5ml 7.5mg/5ml Syrup, sugar free 296,925 L.L
R05DB13 TUSSIN G Butamirate citrate - 7.5mg/5ml 7.5mg/5ml Syrup, sugar free 154,862 L.L
R05FA02 TUSCALMAN A B Noscapine HCl - 5mg, Guaifenesin - 25mg Suppository 569,093 L.L
R05FA02 TUSCALMAN B B Noscapine HCl - 10mg, Guaifenesin - 50mg Suppository 560,924 L.L
R05X TRIMEDIL FORTE G O-(?-hydroxyethyl)-rutosides - 30mg, Ascorbic acid - 80mg, Dimethindene - 0.5mg, Phenylephrine HCl - 2.5mg, Paracetamol - 200mg Capsule 386,515 L.L
R06AD08 TOPLEXIL B Oxomemazine HCl - 0.33mg/ml 0.33mg/ml Syrup 615,480 L.L
S01AA09 TETRACYCLINE EYE OINTMENT G Tetracycline HCl - 1% 1% Ointment 71,672 L.L
S01AA12 TOBRASTILL G Tobramycin - 0.3% 0.3% Drops solution 258,018 L.L
S01AA12 TOBRACIN G Tobramycin - 0.3% 0.3% Drops 322,522 L.L
S01AA12 TOBRACIN G Tobramycin - 0.3% 0.3% Ointment 280,863 L.L
S01AE06 TYMER G Gatifloxacin (sesquihydrate) - 3mg/ml 3mg/ml Drops solution 427,342 L.L
S01ED51 TWINZOL G Dorzolamide HCl - 2%, Timolol - 0.5% Drops solution 632,950 L.L
S01ED51 TRAVOPROST/TIMOLOL BIOGARAN G Travoprost - 40mcg/ml, Timolol - 5mg/ml Drops solution 849,308 L.L
S01EE04 TRAVATAN B Travoprost - 40mcg/ml 0.004% Drops solution 806,306 L.L
S01EE04 TRAVOPROST BIOGARAN Travoprost - 40mcg/ml 40mcg/ml Drops solution 564,414 L.L
S01FA06 TROPICIL TOP G Tropicamide - 10mg/ml 10mg/ml Drops solution 200,233 L.L
S01XA20 TEARS NATURALE B Duasorb - 0.4% 0.4% Drops solution 189,482 L.L
S02AA30 TYOTOCIN B Hexylresorcinol - 0.1%, Antipyrine - 5%, Benzocaine - 1.25%, Tyrothricin - 0.05% Drops solution 409,552 L.L
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