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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
N03AX11 TOPAMAX B Topiramate - 100mg 100mg Tablet, film coated 3,471,145 L.L
N05AX13 BYANNLI B Paliperidone - 1000mg 1000mg Injectable suspension, prolonged release 135,844,746 L.L
R05FA02 TUSCALMAN B B Noscapine HCl - 10mg, Guaifenesin - 50mg Suppository 592,528 L.L
C08DB01 MONO-TILDIEM LP/SR B Diltiazem HCl - 300mg 300mg Capsule, sustained release 658,483 L.L
L01DB06 ZAVEDOS B Idarubicin HCl - 10mg 10mg Injectable freeze dried material 12,071,013 L.L
N05AX13 BYANNLI B Paliperidone - 700mg 700mg Injectable suspension, prolonged release 93,221,562 L.L
C09DX03 VOCADO HCT B Olmesartan medoxomil - 40mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,523,917 L.L
L01XX52 VENCLEXTA B Venetoclax - 10mg 10mg Tablet 12,966,030 L.L
L01DC01 BLEOCIN B Bleomycin (sulfate) - 15U 15U Injectable lyophilised powder for solution 2,109,833 L.L
L01XX52 VENCLEXTA B Venetoclax - 50mg 50mg Tablet 31,367,183 L.L
A10BD08 GALVUS MET B Metformin HCl - 1,000mg, Vildagliptin - 50mg Tablet, film coated 1,816,875 L.L
B01AC06 ASPIRIN PROTECT B Acetylsalicylic acid - 100mg 100mg Tablet, enteric coated 146,479 L.L
C09DX04 ENTRESTO B Valsartan - 26mg, Sacubitril - 24mg Tablet, film coated 6,029,821 L.L
J05AF13 VEMLIDY B Tenofovir alafenamide fumarate - 25mg 25mg Tablet, film coated 25,968,918 L.L
L01XX52 VENCLEXTA B Venetoclax - 100mg 100mg Tablet 707,858,935 L.L
M09AX01 HYALGAN B Hyaluronic acid (sodium) - 20mg/2ml 20mg/2ml Injectable solution 3,407,985 L.L
P01AB01 FLAGYL B Metronidazole - 500mg 500mg Tablet, film coated 310,428 L.L
C09DX04 ENTRESTO B Valsartan - 51mg, Sacubitril - 49mg Tablet, film coated 6,029,821 L.L
L01XX52 VENCLEXTA B Venetoclax - 10mg week 1, Venetoclax - 50mg week 2, Venetoclax - 100mg week 3&4 Tablet 190,943,809 L.L
M09AX10 EVRYSDI B Risdiplam - 0.75mg/ml 0.75mg/ml Powder 865,644,067 L.L
R05X DULSANA COUGH B Menthol - 0.25mg/5ml, Ammonium chloride - 100mg/5ml, Ephedrine HCl - 4mg/5ml, Carbinoxamine maleate - 2mg/5ml Syrup 223,974 L.L
C09DX04 ENTRESTO B Valsartan - 103mg, Sacubitril - 97mg Tablet, film coated 11,674,240 L.L
D06AX01 FUCIDIN B Fusidic acid (sodium salt) - 20mg/g 2% Ointment 259,362 L.L
J01DI01 ZEVTERA B Ceftobiprole medocaril Sodium - 500mg 500mg Injectable powder for concentrate for solution 47,129,773 L.L
L01XX74 WELIREG B Belzutifan - 40mg 40mg Tablet, film coated 1,550,772,301 L.L
N05AX16 REXULTI B Brexpiprazole - 4mg 4mg Tablet, film coated 13,433,051 L.L
R05X DULSANA MILD B Menthol - 0.125mg/5ml, Citric acid - 10mg/5ml, Sodium citrate - 20mg/5ml, Ammonium chloride - 50mg/5ml, Ephedrine HCl - 1.8mg/5ml, Carbinoxamine maleate - 1mg/5ml Syrup 216,295 L.L
V03AC03 JADENU B Deferasirox - 180mg 180mg Tablet, film coated 34,062,918 L.L
C10AA01 ZOCOR B Simvastatin - 10mg 10mg Tablet 881,817 L.L
D06AX01 FUCIDIN OINTMENT B Fusidic acid (sodium salt) - 2% 2% Ointment 491,846 L.L
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