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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
D10AD53 EPIDUO FORTE B Adapalene - 0.3%, Benzoyl peroxide - 2.5% Gel 2,201,214 L.L
M02AA15 GROFENAC G Diclofenac sodium - 1% Emulsion Gel 314,459 L.L
A02BC DANLOX QUICK G Omeprazole - 20mg, Sodium bicarbonate - 1680mg Powder 1,323,685 L.L
C05A ANTROLIN B Nifedipine - 0.3%, Lidocaine - 1.5% Cream 1,333,092 L.L
J01RA MEDSPIRAGYL G Metronidazole - 125mg, Spiramycin - 750,000IU Tablet, scored 474,824 L.L
C05AA01 SEDIPROCT G Hydrocortisone - 500mg, Cinchocaine HCl - 500mg Cream 290,270 L.L
J01RA SPIRAGYL G Metronidazole - 125mg, Spiramycin - 750,000IU Tablet, scored 474,824 L.L
N06CA02 DEANXIT B Flupentixol (dihydrochloride) - 0.5mg, Melitracen (HCl) - 10mg Tablet, film coated 1,372,063 L.L
S01EC54 SIMBRINZA B Brinzolamide - 1%, Brimonidine tartrate - 0.2% Drops suspension 1,706,680 L.L
C05AA01 SEDIPROCT G Hydrocortisone - 5mg, Cinchocaine HCl - 5mg, Framycetin sulfate - 10mg, Esculoside - 10mg Suppository 237,860 L.L
J01RA SPIRAGYL FORTE G Metronidazole - 250mg, Spiramycin - 1,500,000IU Tablet, scored 474,824 L.L
N06CA02 MELIXITE G Flupentixol (dihydrochloride) - 0.5mg, Melitracen (HCl) - 10mg Tablet, film coated 600,250 L.L
R03DA55 CAMPHO-PNEUMINE AMINOPHYLLINE ENFANTS G Eucalyptol - 0.03g, Camphre - 0.04g, Gaiacol ethyl glycolate - 0.12g, Aminophylline - 0.06g Suppository 284,127 L.L
S01ED51 DORZOLAMIDE/TIMOLOL BGR G Timolol maleate - 5mg/ml, Dorzolamide HCl - 20mg/ml Drops solution 689,391 L.L
B05CX01 DEXTROSE INJECTION 5% G Dextrose, H2O - 5g/100ml Injectable solution 212,797 L.L
C05AA01 SINAHEAL-H G Hydrocortisone acetate - 5mg, Lidocaine - 60mg, Zinc oxide - 400mg, Aluminium Subacetate - 50mg Suppository 501,253 L.L
N06CA02 SERNIL G Flupentixol - 0.5mg, Melitracen - 10mg Tablet 1,003,402 L.L
R03DA55 CAMPHO-PNEUMINE AMINOPHYLLINE ENFANTS G Eucalyptol - 0.03g, Camphre - 0.04g, Gaiacol ethyl glycolate - 0.12g, Aminophylline - 0.06g Suppository 426,190 L.L
S01ED51 DORZOPTIC PLUS G Timolol - 0.5%, Dorzolamide HCl - 2% Drops solution 548,288 L.L
C05AA01 SINAHEAL-H G Hydrocortisone acetate - 0.275g/100g, Lidocaine - 5g/100g, Zinc oxide - 18g/100g, Aluminium Subacetate - 3.5g/100g Ointment 330,585 L.L
R03DA55 CAMPHO-PNEUMINE AMINOPHYLLINE ADULTES G Amyleine HCl - 0.01g, Eucalyptol - 0.05g, Camphre - 0.1g, Gaiacol ethyl glycolate - 0.26g, Aminophylline - 0.15g Suppository 326,362 L.L
S01ED51 EPISOPT G Timolol - 5mg, Dorzolamide HCl - 20mg Drops 575,165 L.L
N02BE51 ADOL EXTRA G Paracetamol - 500mg, Caffeine - 65mg Caplet 122,290 L.L
R03DA55 CAMPHO-PNEUMINE AMINOPHYLLINE ADULTES G Amyleine HCl - 0.01g, Eucalyptol - 0.05g, Camphre - 0.1g, Gaiacol ethyl glycolate - 0.26g, Aminophylline - 0.15g Suppository 490,183 L.L
S01ED51 TWINZOL G Dorzolamide HCl - 2%, Timolol - 0.5% Drops solution 632,950 L.L
N02BE51 SICADOL EXTRA G Paracetamol - 500mg, Caffeine - 65mg Tablet 147,823 L.L
R03DB05 THEODEX G Ipeca fluide extract - 20mg, Aminophylline - 150mg, Caffeine - 100mg, Ephedrine - 15mg Tablet 156,142 L.L
S01ED51 XOLAMOL G Timolol (maleate) - 5mg/ml, Dorzolamide HCl - 20mg/ml Drops solution 678,640 L.L
C05AX HEMOCARE G Bismuth subgallate - 100mg, Zinc oxide - 100mg, Lidocaine - 60mg Suppository 588,731 L.L
S01ED51 XALACOM B Timolol (maleate) - 6.8mg/ml, Latanoprost - 50?g/ml Drops solution 510,660 L.L
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