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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
N06BA04 CONCERTA B Methylphenidate HCl - 18mg 18mg Tablet, extended release 3,133,841 L.L
R03BB01 ATROVENT B Ipratropium bromide - 250mcg/2ml 250mcg/2ml Inhaltion solution with nebuliser 544,256 L.L
L01BA04 ALIMTA B Pemetrexed (disodium) - 100mg 100mg Injectable concentrated powder for solution 16,854,009 L.L
N05AH03 ZYPREXA VELOTAB B Olanzapine - 5mg 5mg Tablet, dispersible 2,607,054 L.L
R03BB01 ATROVENT B Ipratropium bromide - 500mcg/2ml 500mcg/2ml Inhaltion solution with nebuliser 713,580 L.L
A02BC05 NEXIUM B Esomeprazole (magnesium trihydrate) - 10mg 10mg Granules, gastroresistant, for suspension 1,721,462 L.L
C10AX06 VASCEPA B Eicosapentaenoic acid (Ethyl ester) - 1g 1g Capsule 21,464,912 L.L
N05AH03 ZYPREXA VELOTAB B Olanzapine - 5mg 5mg Tablet, dispersible 2,607,054 L.L
S01CA01 FRAKIDEX B Dexamethasone disodium phosphate - 0.1g/100g, Framycetin sulfate - 0.5g/100g Ointment 141,103 L.L
A02BC05 NEXIUM B Esomeprazole (magnesium trihydrate) - 10mg 10mg Granules, gastroresistant, for suspension 1,721,462 L.L
C10AX09 EZETROL B Ezetimibe - 10mg 10mg Tablet 3,680,849 L.L
R03BB01 ATROVENT N B Ipratropium bromide - 20mcg/actuation 20mcg/actuation Inhalation aerosol metered dose 428,686 L.L
A02BC06 DEXILANT B Dexlansoprazole - 30mg 30mg Capsule, delayed release 1,595,141 L.L
S01CA01 NETILDEX B Dexamethasone - 0.1%, Netilmicin - 0.3% Drops solution 752,552 L.L
A02BC06 DEXILANT B Dexlansoprazole - 60mg 60mg Capsule, delayed release 2,375,914 L.L
C07AB05 KERLONE B Betaxolol HCl - 20mg 20mg Tablet, film coated, scored 575,165 L.L
C09DA03 CO-DIOVAN B Valsartan - 160mg, Hydrochlorothiazide - 25mg Tablet, film coated 901,718 L.L
L01BB02 PURI-NETHOL B Mercaptopurine - 50mg 50mg Tablet 830,495 L.L
R03BB04 SPIRIVA WITH HANDIHALER B Tiotropium bromide - 18mcg 18mcg Capsule, inhalation 3,179,531 L.L
A02BC07 DEXPURE B Dexrabeprazole sodium - 10mg 10mg Tablet, enteric coated 517,379 L.L
C07AB07 CONCOR B Bisoprolol fumarate - 5mg 5mg Tablet, film coated 837,017 L.L
L01BB04 LITAK 10 B Cladribine - 2mg/ml 2mg/ml Injectable solution 124,768,660 L.L
N02BE01 EFFERALGAN B Paracetamol - 3% 3% Solution 163,949 L.L
S01EA05 ALPHAGAN P B Brimonidine tartrate - 1.5mg/ml 0.15% Drops solution 999,819 L.L
A02BD08 PYLERA B Bismuth subcitrate potassium - 140mg, Tetracycline HCl - 125mg, Metronidazole - 125mg Capsule 6,156,142 L.L
D11AX01 REGAINE FOAM FOR MEN B Minoxidil - 5% Foam 1,370,719 L.L
L01BB04 LITAK 10 B Cladribine - 10mg/5ml 10mg/5ml Injectable solution 39,016,157 L.L
N02BE01 EFFERALGAN B Paracetamol - 1g 1g Tablet, effervescent 129,009 L.L
S01EA05 ALPHAGAN P B Brimonidine tartrate - 1.5mg/ml 0.15% Drops solution 999,819 L.L
D11AX01 REGAINE FOAM FOR MEN B Minoxidil - 5% Foam 3,090,838 L.L
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