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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
N03AX18 VIMPAT B Lacosamide - 10mg/ml 10mg/ml Syrup 2,111,177 L.L
R03AC02 VENTOLIN EVOHALER B Salbutamol (sulfate) - 100mcg/dose 100mcg/dose Inhalation aerosol metered dose 260,705 L.L
D07AC18 PEITEL B Prednicarbate - 0.25% 0.25% Cream 507,972 L.L
J07AL01 PNEUMOVAX 23 B Polysaccharides from each of 23 capsular types of Streptococcus pneumoniae - 25mcgx23serotypes/0.5ml Injectable solution 2,378,601 L.L
M01AE03 PROFEMIGR B Ketoprofen - 150mg 150mg Tablet, scored 302,365 L.L
N03AX22 FYCOMPA B Perampanel - 2mg 2mg Tablet, film coated 1,138,235 L.L
C09BB04 COVERAM B Perindopril arginine - 10mg, Amlodipine - 10mg Tablet 1,116,733 L.L
D07AD01 DERMOVATE B Clobetasol (propionate) - 0.5mg/g 0.05% w/w Cream 290,270 L.L
J07AL02 PREVENAR 13 B Polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 23F (2.2mcg)Polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 6,352,343 L.L
M01AE03 PROFENID B Ketoprofen - 100mg 100mg Tablet, film coated 469,001 L.L
N03AX22 FYCOMPA B Perampanel - 4mg 4mg Tablet, film coated 8,751,127 L.L
L04AA10 RAPAMUNE B Sirolimus - 1mg 1mg Tablet L.L
A06AD11 DUPHALAC B Lactulose - 6.7g/10ml 6.7g/10ml Solution 454,219 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 850mg 12.5mg/850mg Tablet, film coated 3,052,874 L.L
C02KX01 TRACLEER B Bosentan (monohydrate) - 125mg 125mg Tablet, film coated 79,583,961 L.L
J07AL02 SYNFLORIX B Polysaccharide from each of 10 capsular types of pneumococcus (conjugated to carrier proteins) adsorbed onto aluminium phosphate - 1mcg/0.5ml, Polysaccharide of serotypes 41,2, 18C1,3 and 19F1,4 - 3mcg/0.5ml, 1 adsorbed onto aluminium phosphate - 0.5mg Al3+, 2 conjugated to protein D (derived from NTHi) carrier protein - ~ 13mcg, 3 conjugated to tetanos toxoid carrier protein - ~ 8mcg, 4 conjugated to diphteria toxoid carrier protein - ~ 5mcg Injectable suspension 4,675,228 L.L
L01EF01 IBRANCE B Palbociclib - 125mg 125mg Capsule 172,164,216 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 100mg 100mg Tablet, modified release 236,516 L.L
N03AX22 FYCOMPA B Perampanel - 6mg 6mg Tablet, film coated 8,751,127 L.L
R03AC02 VENTOLIN B Salbutamol (sulfate) - 5mg/ml 5mg/ml Solution 403,153 L.L
A10BD20 SYNJARDY B Empagliflozin - 5mg, Metformin HCl - 850mg 5mg/850mg Tablet, film coated 3,052,874 L.L
C02KX01 TRACLEER B Bosentan (monohydrate) - 125mg 125mg Tablet, film coated 79,583,961 L.L
L01EF01 IBRANCE B Palbociclib - 125mg 125mg Tablet, film coated 172,164,216 L.L
M01AE03 BI-PROFENID LP B Ketoprofen - 100mg 100mg Tablet, prolonged release 392,402 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 150mg 150mg Tablet, modified release 356,118 L.L
N03AX22 FYCOMPA B Perampanel - 8mg 8mg Tablet, film coated 10,180,812 L.L
L04AA18 CERTICAN B Everolimus - 0.5mg 0.5mg Tablet L.L
J01CR05 PIPERACILLINE/ TAZOBACTAM ARROW Piperacillin (sodium) - 4g, Tazobactam (sodium) - 500mg 7,378,682 L.L
J01CR05 TAZOBACT Piperacillin sodium - 4g, Tazobactam (sodium) - 500mg 783,460 L.L
N02BE51 PARACETAMOL/CAFEINE/CODEINE BIOGARAN Paracetamol - 400mg, Caffeine - 50mg, Codeine - 20mg 548,288 L.L
    ...
    181
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