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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
A10BD15 DIVINUSMET XR G Dapagliflozin - 5mg, Metformin HCl XR - 1000mg Tablet, extended release 2,900,012 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 613,662 L.L
C01EB17 BRAVIGO G Ivabradine (HCl) - 7.5mg 7.5mg Tablet, film coated 1,237,679 L.L
C09BA01 CAPTACE PLUS G Hydrochlorothiazide - 25mg, Captopril - 50mg Tablet, scored 1,028,487 L.L
C10AA05 ATORVASTATINE ARROW GENERIQUES G Atorvastatin - 10mg 10mg Tablet, coated 567,102 L.L
D07AC04 FLUOCINOLONE ACETONIDE G Fluocinolone acetonide - 0.25mg/g 0.25mg/g Cream 296,925 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 600mg/5ml, Clavulanic Acid (potassium) - 42.9mg/5ml 642.9mg/5ml Powder for suspension 507,972 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 40mg/2ml 40mg/2ml Injectable solution 643,701 L.L
M01AE01 IBUPROFEN B. BRAUN G Ibuprofen - 400mg/100ml 400mg/100ml Injectable solution 231,141 L.L
N03AX16 PLENICA G Pregabalin - 25mg 25mg Capsule 697,454 L.L
N06AB06 SERTINE G Sertraline HCl - 50mg 50mg Tablet, scored 520,899 L.L
R01BA52 ORADUS P G Pseudoephedrine sulfate - 120mg, Desloratadine - 2.5mg Tablet, extended release 746,153 L.L
A04AD12 APREPITANT BIOGARAN G Aprepitant - 80mg 80mg Capsule 2,164,930 L.L
A10BD15 ZYGLOMET XR 5/1000 G Dapagliflozin - 5mg, Metformin HCl XR - 1000mg Tablet, film coated 2,578,386 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 344,754 L.L
C01EB17 IVABRADINE ARROW G Ivabradine (HCl) - 7.5mg 7.5mg Tablet, film coated, scored 1,323,685 L.L
C10AA05 JOSWE ATORVAST 10 G Atorvastatin - 10mg 10mg Caplet, film coated 849,308 L.L
D07AC13 ELICA G Mometasone furoate - 1mg/g 0.1% Cream 341,336 L.L
J01CR02 BETAMOX ES G Amoxicillin - 600mg/5ml, Clavulanic Acid - 42.9mg/5ml Powder for suspension 592,635 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 40mg/2ml 40mg/2ml Injectable solution 643,701 L.L
M01AE01 ? IBUPROFEN G Ibuprofen - 400mg/100ml 400mg/100ml Injectable solution 383,955 L.L
N03AX16 PMS-PREGABALIN G Pregabalin - 25mg 25mg Capsule 770,022 L.L
N06AB06 SERTINE G Sertraline HCl - 50mg 50mg Tablet 714,156 L.L
R01BA52 ORADUS P G Pseudoephedrine sulfate - 120mg, Desloratadine - 2.5mg Tablet, extended release 255,970 L.L
R06AX13 CLARA G Loratadine (micronised) - 5mg/5ml 5mg/5ml Syrup 215,015 L.L
A04AD12 APREPITANT BIOGARAN 125MG APREPITANT BIOGARAN 80MG G Aprepitant - 125mg, Aprepitant - 80mg 125mg Capsule 3,246,723 L.L
B05BC01 MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
C09BA03 TENSIKEY COMPLEX G Lisinopril - 20mg, Hydrochlorothiazide - 12.5mg Tablet 536,193 L.L
C10AA05 LIPODAR G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 1,323,685 L.L
D07AC13 ELISONE G Mometasone furoate - 0.1% 0.1% Cream 249,955 L.L
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