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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
N03AA02 GARDENAL B Phenobarbital - 100mg 100mg Tablet 120,946 L.L
N05AX08 RISPERDAL B Risperidone - 2mg 2mg Tablet, film coated 306,396 L.L
D01AE16 LOCERYL B Amorolfine - 125mg/2.5ml 5% Nail lacquer 1,076,418 L.L
J02AC05 CRESEMBA B Isavuconazonium sulfate - 200mg 200mg Injectable powder for concentrate for solution 38,436,952 L.L
N03AB02 EPANUTIN B Phenytoin sodium - 100mg 100mg Capsule 739,113 L.L
A10BB12 AMARYL B Glimepiride - 1mg 1mg Tablet 231,141 L.L
C09DB01 EXFORGE B Amlodipine - 10mg, Valsartan - 160mg Tablet, film coated 1,333,092 L.L
J02AX04 CANCIDAS B Caspofungin (acetate) - 70mg 70mg Injectable concentrated powder for solution 31,611,335 L.L
M04AA03 ADENURIC B Febuxostat - 120mg 120mg Tablet, film coated 2,184,704 L.L
A03CB01 RESTROPINAL PEDIATRIC B Butobarbital - 2mg/ml, Methyl hyoscine nitrate - 0.1mg/ml Drops 197,097 L.L
C07BB07 CONCOR PLUS B Bisoprolol fumarate - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,202,314 L.L
D01AE22 EXODERIL B Naftifine HCl - 10mg/g 1% Cream 345,368 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 1,189,301 L.L
L04AX04 REVLIMID B Lenalidomide - 10mg 10mg Capsule 110,200,672 L.L
N07BC01 BUVIDAL B Buprenorphine - 8mg 8mg Injectable solution prolonged release 8,524,771 L.L
S01HA02 ANESTOCIL B Oxybuprocaine HCl (Benoxinate HCl) - 0.4% 0.4% Drops solution 442,124 L.L
A03DB04 PANADOL WOMAN B Paracetamol - 500mg, Hyoscine butylbromide - 10mg Tablet, coated 436,749 L.L
C07BB12 NEBILET PLUS B Nebivolol HCl - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 716,268 L.L
D01AE22 EXODERIL B Naftifine HCl - 10ml/ml 1% Solution 159,917 L.L
G02CX01 TRACTOCILE B Atosiban acetate - 7.5mg/ml 7.5mg/ml Injectable solution 2,592,272 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 2,025,171 L.L
N03AE01 RIVOTRIL B Clonazepam - 0.5mg 0.5mg Tablet, scored 403,153 L.L
N07BC01 BUVIDAL B Buprenorphine - 16mg 16mg Injectable solution prolonged release 8,524,771 L.L
R05CA12 PROSPAN ACUTE EFFERVESCENT COUGH TABLETS B Dried Ivy leaf extract - 65mg Tablet, effervescent 479,752 L.L
C07BB12 NEBILET PLUS B Nebivolol HCl - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 716,268 L.L
G02CX01 TRACTOCILE B Atosiban acetate - 7.5mg/ml 7.5mg/ml Injectable solution 8,282,804 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 2,025,171 L.L
J02AX04 CANCIDAS B Caspofungin (acetate) - 50mg 50mg Injectable concentrated powder for solution 25,799,521 L.L
N03AE01 RIVOTRIL B Clonazepam - 2mg 2mg Tablet, scored 503,941 L.L
N05AX08 RISPERDAL B Risperidone - 4mg 4mg Tablet, film coated 498,566 L.L
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