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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
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
M02AA10 FASTUM B Ketoprofen - 2.5g/100g 2.5% Gel 177,387 L.L
M02AA10 FASTUM B Ketoprofen - 2.5g/100g 2.5% Gel 337,304 L.L
S01CA01 FRAKIDEX B Dexamethasone disodium phosphate - 0.1g/100g, Framycetin sulfate - 0.5g/100g Ointment 141,103 L.L
M02AA15 FLECTOR E.P TISSUGEL B Diclofenac (epolamine) - 1% 1% Patch 1,204,083 L.L
G01AC05 FLUOMIZIN B Dequalinium chloride - 10mg 10mg Tablet 775,397 L.L
G01AF01 FLAGYL B Metronidazole - 500mg 500mg Ovule 249,955 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
M05BA04 FOSAMAX 70MG ONCE WEEKLY B Alendronate - 70mg 70mg Tablet 1,988,887 L.L
R05CB01 FLUIMUCIL MUCOLYTIC B N-acetylcysteine - 2% 2% Syrup 595,322 L.L
D04AA13 FENISTIL B Dimethindene maleate - 1mg/g 1mg/g Gel 196,201 L.L
N07XX07 FAMPYRA B Fampridine - 10mg 10mg Tablet, prolonged release 17,636,804 L.L
N07XX07 FAMPYRA B Fampridine - 10mg 10mg Tablet, prolonged release 18,175,448 L.L
C01BC04 FLECAINE B Flecainide acetate - 100mg 100mg Tablet, scored 878,873 L.L
M05BB03 FOSAVANCE B Alendronic acid (sodium alendronate) - 70mg, Colecalciferol - 5600IU Tablet 1,988,887 L.L
P01AB01 FLAGYL B Metronidazole - 500mg 500mg Tablet, film coated 310,428 L.L
D06AX01 FUCIDIN B Fusidic acid - 20mg/g 2% Cream 259,362 L.L
D06AX01 FUCIDIN CREAM B Fusidic acid - 2% 2% Cream 491,846 L.L
D06AX01 FUCIDIN CREAM B Fusidic acid - 2% 2% Cream 345,368 L.L
P01AB01 FLAGYL B Metronidazole - 250mg 250mg Tablet, film coated 176,043 L.L
D06AX01 FUCIDIN B Fusidic acid (sodium salt) - 20mg/g 2% Ointment 259,362 L.L
D06AX01 FUCIDIN OINTMENT B Fusidic acid (sodium salt) - 2% 2% Ointment 491,846 L.L
D06AX01 FUCIDIN OINTMENT B Fusidic acid (sodium salt) - 2% 2% Ointment 345,368 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
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