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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
N02CX01 APIZINE G Pizotifen - 0.25mg/5ml 0.25mg/5ml Syrup 505,541 L.L
N07BB03 ACAMPROSATE BIOGARAN G Acamprosate - 333mg 333mg Tablet, gastroresistant 3,641,813 L.L
M04AA01 APO-ALLOPURINOL G Allopurinol - 300mg 300mg Tablet 626,231 L.L
R05CA ASPECTON COUGH SYRUP G Thyme soft extract - 6.69g/100ml Syrup 588,603 L.L
M04AA01 ALLOPURINOL BIOGARAN G Allopurinol - 200mg 200mg Tablet 169,324 L.L
D01AE16 AMOROLFINE BGR G Amorolfine - 5% 5% Nail lacquer 753,896 L.L
A10BB12 AMEPRIDE G Glimepiride - 1mg 1mg Tablet 137,072 L.L
C09DB01 AMLODIPINE/VALSARTAN ARROW G Amlodipine (besylate) - 10mg, Valsartan - 160mg Tablet, coated 923,220 L.L
C09DB01 ANGIOSAR G Amlodipine besylate - 10mg, Valsartan - 160mg Tablet, film coated 857,372 L.L
A03E ACTICARBINE G Activated charcoal - 70mg, Papaverine HCl - 14mg Tablet, coated 311,771 L.L
C09DB01 ARBITEN AM 10/160 G Amlodipine - 10mg, Valsartan - 160mg Caplet, film coated 857,372 L.L
N03AF01 APO-CARBAMAZEPINE G Carbamazepine - 200mg 200mg Tablet 727,019 L.L
D01BA02 APO-TERBINAFINE G Terbinafine HCl - 250mg 250mg Tablet 1,409,691 L.L
A10BB12 AMEPRIDE G Glimepiride - 2mg 2mg Tablet 139,760 L.L
C09DB01 AMLODIPINE/VALSARTAN ARROW G Amlodipine (besylate) - 5mg, Valsartan - 80mg Tablet, coated 807,649 L.L
C08CA01 AMLINE G Amlodipine - 5mg 5mg Tablet, scored 358,358 L.L
C08CA01 AMLO TAD G Amlodipine besylate - 5mg 5mg Tablet 744,489 L.L
C08CA01 AMLOCARD G Amlodipine (besylate) - 5mg 5mg Tablet 473,545 L.L
J05AB01 ASIMPLEX G Aciclovir - 250mg 250mg Injectable lyophilised powder for solution 278,175 L.L
C08CA01 AMLOCOEUR G Amlodipine - 5mg 5mg Tablet 362,198 L.L
N07CA01 ALVIGO G Betahistine dihydrochloride - 16mg 16mg Tablet, scored 1,204,339 L.L
B05XA31 ADDAVEN G Chromic chloride 6H2O - 53mcg/10ml, Copper chloride dihydrate - 1.02mg/10ml, Ferric Chloride hexahydrate - 5.40mg/10ml, Manganese chloride 4H2O - 198mcg/10ml, Potassium iodide - 166mcg/10ml, Sodium fluoride - 2.10mg/10ml Injectable concentrate for solution 4,065,124 L.L
C08CA01 AMLODAR 5 G Amlodipine (besylate) - 5mg 5mg Capsule 362,837 L.L
N05AX12 ABIPREX 10 G Aripiprazole - 10mg 10mg Tablet 1,075,074 L.L
R05CB01 ACC LONG G N-acetylcysteine - 600mg, Vitamin C - 75mg 600mg Tablet, effervescent 286,238 L.L
C08CA01 AMLODIPINE ARROW G Amlodipine (besylate) - 5mg 5mg Capsule 462,282 L.L
J05AB01 ACTI-VIR G Aciclovir - 200mg 200mg Tablet, scored 1,039,238 L.L
N05AX12 ATYPRAL G Aripiprazole - 10mg 10mg Tablet 712,237 L.L
A10BB12 AMEPRIDE G Glimepiride - 3mg 3mg Tablet 215,015 L.L
C08CA01 AMLODIPINE BIOGARAN G Amlodipine (besylate) - 5mg 5mg Capsule 462,282 L.L
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