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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
C09AA05 APO-RAMIPRIL G Ramipril - 5mg 5mg Capsule 794,211 L.L
L01EF01 IBRANCE B Palbociclib - 75mg 75mg Capsule 172,164,216 L.L
N02AX02 TRAMAL B Tramadol HCl - 50mg 50mg Capsule 349,399 L.L
C09AA05 TRILTEC G Ramipril - 5mg 5mg Capsule 447,948 L.L
L01EF01 PALBRANCE 75 G Palbociclib - 75mg 75mg Capsule 168,011,222 L.L
C09AA05 APO-RAMIPRIL G Ramipril - 10mg 10mg Capsule 1,178,550 L.L
L01EF01 IBRANCE B Palbociclib - 100mg 100mg Capsule 172,164,216 L.L
L01EF01 PALBOMED G Palbociclib - 100mg 100mg Capsule 23,911,751 L.L
C09AA05 TRILTEC G Ramipril - 10mg 10mg Capsule 575,933 L.L
L01EF01 PALBRANCE 100 G Palbociclib - 100mg 100mg Capsule 168,011,222 L.L
L01EF01 IBRANCE B Palbociclib - 125mg 125mg Capsule 172,164,216 L.L
L01EF01 PALBOMED G Palbociclib - 125mg 125mg Capsule 25,799,521 L.L
L01EF01 PALBRANCE 125 G Palbociclib - 125mg 125mg Capsule 69,032,469 L.L
L04AA06 CELLCEPT B Mycophenolate mofetil - 250mg 250mg Capsule 6,083,575 L.L
J07AX URO-VAXOM B Lyophilized bacterial lysates of E-Coli - 6mg 6mg Capsule 2,689,029 L.L
N04BB01 SYMMETREL B Amantadine - 100mg 100mg Capsule 568,253 L.L
J07AX BRONCHO-VAXOM CHILDREN B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 3.5mg Capsule 1,988,887 L.L
J07AX BRONCHO-VAXOM ADULTS B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 7mg Capsule 2,746,814 L.L
M01AH01 CELECOXIB BIOGARAN G Celecoxib - 100mg 100mg Capsule 318,491 L.L
M01AH01 CELEBREX B Celecoxib - 200mg 200mg Capsule 1,126,140 L.L
L04AA27 GILENYA B Fingolimod - 0.5mg 0.5mg Capsule 159,392,560 L.L
M01AH01 CELECOXIB ARROW LAB G Celecoxib - 200mg 200mg Capsule 561,726 L.L
M01AH01 CELECOXIB BIOGARAN G Celecoxib - 200mg 200mg Capsule 638,325 L.L
L04AA27 PMS-FINGOLIMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 19,351,580 L.L
M01AH01 JOSWE FLAMEX 200 G Celecoxib - 200mg 200mg Capsule 225,766 L.L
A04AD12 APREPITANT BIOGARAN G Aprepitant - 80mg 80mg Capsule 2,164,930 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 18,264,981 L.L
M01AH01 JOSWE FLAMEX 200 G Celecoxib - 200mg 200mg Capsule 636,981 L.L
A04AD12 APREPITANT BIOGARAN 125MG APREPITANT BIOGARAN 80MG G Aprepitant - 125mg, Aprepitant - 80mg 125mg Capsule 3,246,723 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 17,079,643 L.L
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