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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
R03AK07 FORACORT 400 G Formoterol fumarate - 4.5mcg/inhalation, Budesonide - 400mcg/inhalation Metered dose inhaler 3,104,276 L.L
R03BA05 FLIXOTIDE EVOHALER B Fluticasone propionate - 250mcg/actutaion 250mcg/actutaion Inhalation suspension 1,484,946 L.L
R03BA05 FLIXOTIDE EVOHALER B Fluticasone propionate - 125mcg/actuation 125mcg/actuation Inhalation suspension 794,211 L.L
R03BA05 FLIXOTIDE EVOHALER B Fluticasone propionate - 50mcg/actuation 50mcg/actuation Inhalation suspension 671,921 L.L
R03DX10 FASENRA B Benralizumab - 30mg 30mg Injectable solution 214,213,273 L.L
R05CB01 FLUIMUCIL B N-acetylcysteine - 600mg 600mg Tablet, effervescent 567,102 L.L
R05CB01 FLUIMUCIL MUCOLYTIC B N-acetylcysteine - 2% 2% Syrup 595,322 L.L
R05CB06 FLUIBRON G Ambroxol - 15mg/5ml 15mg/5ml Syrup 459,594 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
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 393,746 L.L
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 550,821 L.L
R06AE07 FINALLERG G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 342,680 L.L
R06AE07 FINALLERG G Cetirizine (dihydrochloride) - 5mg/5ml 5mg/5ml Solution 170,668 L.L
R06AX FRENALER CORT G Desloratadine - 1mg/ml, Betamethasone - 0.05mg/ml Syrup 741,801 L.L
R06AX FRENALER CORT G Desloratadine - 5mg, Betamethasone - 0.6mg Tablet, film coated 632,950 L.L
R06AX26 FENADEX 120 G Fexofenadine HCl - 120mg 120mg Tablet, coated 295,645 L.L
R06AX26 FENADEX 180 G Fexofenadine HCl - 180mg 180mg Tablet, coated 295,645 L.L
S01AA13 FUCITHALMIC VISCOUS B Fusidic acid - 10mg/g 1% Drops 373,588 L.L
S01AE01 FLOXIGEN G Ofloxacin - 3mg/ml 3mg/ml Drops solution 358,806 L.L
S01AE01 FLOXEDOL G Ofloxacin - 3mg/ml 3mg/ml Gel 339,992 L.L
S01AE07 FORTYMOX G Moxifloxacin (HCl) - 0.5% 0.5% Drops solution 772,709 L.L
S01BC04 FLUROPTIC G Flurbiprofen sodium - 0.03% w/v 0.03% w/v Drops solution 223,078 L.L
S01CA01 FRAKIDEX B Dexamethasone disodium phosphate - 0.1g/100g, Framycetin sulfate - 0.5g/100g Ointment 141,103 L.L
S01JA01 FLUORESCEIN SODIUM USP IV G Fluorescein sodium - 10% 10% Injectable solution 1,198,595 L.L
S01JA01 FLUORESCEIN SODIUM USP IV G Fluorescein sodium - 10% 10% Injectable solution 10,787,353 L.L
V03AE02 FOSEAL-800 G Sevelamer HCl - 800mg 800mg Tablet, film coated 470,345 L.L
V03AE02 FOSEAL-800 G Sevelamer HCl - 800mg 800mg Tablet, film coated 7,977,094 L.L
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