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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
M02AA10 FASTUM B Ketoprofen - 2.5g/100g 2.5% Gel 337,304 L.L
M02AA15 FLECTOR E.P TISSUGEL B Diclofenac (epolamine) - 1% 1% Patch 1,204,083 L.L
M03BA53 FLEXPRO EXTRA G Paracetamol - 500mg, Methocarbamol - 400mg Tablet, film coated 337,304 L.L
M04AA03 FEBUXOSTAT ARROW G Febuxostat - 120mg 120mg Tablet, film coated 1,084,481 L.L
M04AA03 FEBUXOSTAT BIOGARAN G Febuxostat - 120mg 120mg Tablet, film coated 1,402,972 L.L
M04AA03 FEBUXOSTAT ARROW G Febuxostat - 80mg 80mg Tablet, film coated 1,084,481 L.L
M04AA03 FEBUXOSTAT BIOGARAN G Febuxostat - 80mg 80mg Tablet, film coated 1,402,972 L.L
M05BA04 FOSAMAX 70MG ONCE WEEKLY B Alendronate - 70mg 70mg Tablet 1,988,887 L.L
M05BB03 FOSAVANCE B Alendronic acid (sodium alendronate) - 70mg, Colecalciferol - 5600IU Tablet 1,988,887 L.L
N01AH01 FENTANYL PANPHARMA G Fentanyl - 0.1mg/2ml 0.1mg/2ml Injectable solution 1,101,951 L.L
N01AH01 FENTANYL HAMELN G Fentanyl (citrate) - 0.5mg/10ml 0.5mg/10ml Injectable solution 1,206,771 L.L
N01AH01 FENTANYL MEDIS G Fentanyl (citrate) - 0.5mg/10ml 0.5mg/10ml Injectable solution 1,190,644 L.L
N01AH01 FENTANYL PANPHARMA G Fentanyl - 0.5mg/10ml 0.5mg/10ml Injectable solution 1,243,054 L.L
N02BE01 FEBRADOL G Paracetamol - 500mg 500mg Tablet 327,642 L.L
N02BE01 FEBRADOL JOINT G Paracetamol - 665mg 665mg Tablet 289,246 L.L
N03AX22 FYCOMPA B Perampanel - 10mg 10mg Tablet, film coated 12,176,386 L.L
N03AX22 FYCOMPA B Perampanel - 2mg 2mg Tablet, film coated 1,138,235 L.L
N03AX22 FYCOMPA B Perampanel - 4mg 4mg Tablet, film coated 8,751,127 L.L
N03AX22 FYCOMPA B Perampanel - 6mg 6mg Tablet, film coated 8,751,127 L.L
N03AX22 FYCOMPA B Perampanel - 8mg 8mg Tablet, film coated 10,180,812 L.L
N05AB02 FLUPHENAZINE HCl G Fluphenazine (HCl) - 5mg 5mg Tablet, scored 624,567 L.L
N06AB03 FLUOXETINE BIOGARAN G Fluoxetine (HCl) - 20mg 20mg Capsule 239,204 L.L
N06AB03 FLUTIN G Fluoxetine (HCl) - 20mg 20mg Capsule 362,837 L.L
N06AB08 FAVERIN B Fluvoxamine maleate - 100mg 100mg Tablet, film-scored 1,291,433 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
P01AB01 FLAGYL B Metronidazole - 500mg 500mg Tablet, film coated 310,428 L.L
P01AB01 FLAGYL B Metronidazole - 250mg 250mg Tablet, film coated 176,043 L.L
R03AK06 FLUDALT DUO G Salmeterol (xinafoate) - 50mcg, Fluticasone propionate - 100mcg Capsule, inhalation 1,709,989 L.L
R03AK06 FLUDALT DUO G Salmeterol (xinafoate) - 50mcg, Fluticasone propionate - 250mcg Capsule, inhalation 2,393,122 L.L
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