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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
N01AH01 FENTANYL PANPHARMA G Fentanyl - 0.5mg/10ml 0.5mg/10ml Injectable solution 1,243,054 L.L
N03AX12 GABAPENTINE ARROW GENERIQUES G Gabapentin - 400mg 400mg Capsule 1,342,499 L.L
N05BA08 BROMAZEPAM BIOGARAN G Bromazepam - 6mg 6mg Tablet, scored 180,075 L.L
V03AE07 PHOSPHOLOW G Calcium acetate - 660mg 660mg Tablet 1,118,077 L.L
A03FA03 PROKININ G Domperidone - 10mg 10mg Tablet, film coated 221,734 L.L
A10BB12 JOSWE GLEMAX 3 G Glimepiride - 3mg 3mg Caplet 506,629 L.L
B05BB02 5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml Injectable solution 226,388 L.L
C08CA01 AMLORINE 10 G Amlodipine (besylate) - 10mg 10mg Tablet 959,504 L.L
C09DX LOSANET AM PLUS G Losartan potassium - 100mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet 1,044,358 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 90,869 L.L
J01AA02 RETADOX G Doxycycline (hyclate) - 100mg 100mg Capsule 209,895 L.L
J01DH51 CELLABAXIN G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable solution 10,699,559 L.L
J05AF10 ENTECAVIR ARROW G Entecavir - 0.5mg 0.5mg Tablet, coated 18,701,506 L.L
M01AB05 DOLONIL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 337,880 L.L
N01AH03 SUFENTANIL RENAUDIN G Sufentanil (citrate) - 250mcg/5ml 250mcg/5ml Injectable solution 3,524,899 L.L
N03AX12 GABATREX G Gabapentin - 400mg 400mg Capsule 1,846,440 L.L
A10BB12 ORBIDE G Glimepiride - 3mg 3mg Tablet 351,959 L.L
B05BB02 5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml Injectable solution 153,990 L.L
C08CA01 TORANS G Amlodipine (besylate) - 10mg 10mg Tablet 716,716 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 174,060 L.L
J01AA02 TOLEXINE G Doxycycline (monohydrate) - 100mg 100mg Tablet, microgranules 589,947 L.L
J01DH51 CILANEM G Imipenem anhydrous - 500mg, Cilastatin (sodium) - 500mg Injectable solution 850,652 L.L
J05AF10 ENTECAVIR BIOGARAN G Entecavir - 0.5mg 0.5mg Tablet, coated 19,080,319 L.L
L01DB07 MITOXANTRON EBEWE G Mitoxantrone - 20mg/10ml 20mg/10ml Injectable concentrated solution 11,064,120 L.L
M01AB05 DOLONIL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 3,801,155 L.L
N01AH03 SUFENTANIL RENAUDIN G Sufentanil (citrate) - 5mcg/ml 10mcg/2ml Injectable solution 755,239 L.L
N03AX12 NEUROPLEX G Gabapentin - 400mg 400mg Capsule 1,290,089 L.L
N05BA12 ALPRAZOLAM BIOGARAN G Alprazolam - 0.5mg 0.5mg Tablet, scored 169,324 L.L
V03AF03 BENDAFOLIN G Calcium folinate - 200mg/20ml 200mg/20ml Injectable solution 3,584,028 L.L
A03FA03 DOMIDONE CHAPHA SUGAR FREE G Domperidone - 5mg/5ml 5mg/5ml Suspension 319,963 L.L
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