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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
N05AX13 TREVICTA B Paliperidone - 350mg 350mg Injectable suspension, prolonged release 48,204,866 L.L
R05DB13 SINECOD B Butamirate dihydrogenocitrate - 5mg/ml 5mg/ml Drops 287,582 L.L
C09DB02 VOCADO B Olmesartan medoxomil - 20mg, Amlodipine besylate - 5mg Tablet, film coated 971,598 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 100mcg 100mcg Tablet, scored 452,875 L.L
L01XJ01 ERIVEDGE B Vismodegib - 150mg 150mg Capsule 465,368,012 L.L
N05AX13 TREVICTA B Paliperidone - 525mg 525mg Injectable suspension, prolonged release 72,306,028 L.L
A10BB12 AMARYL B Glimepiride - 1mg 1mg Tablet 231,141 L.L
G03CC06 GYNOFLOR B Estriol - 0.03mg, Lactobacillus acidophillus - 10 MIU Tablet 813,025 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 150mcg 150mcg Tablet, scored 615,480 L.L
J05AB14 VALCYTE B Valganciclovir (HCl) - 450mg 450mg Tablet, film coated 63,612,039 L.L
L01CE01 HYCAMTIN IV B Topotecan HCl - 4mg 4mg Injectable lyophilised powder for solution 52,580,031 L.L
L01XK01 LYNPARZA B Olaparib - 100mg 100mg Tablet, film coated 230,789,350 L.L
N05AX13 BYANNLI B Paliperidone - 1000mg 1000mg Injectable suspension, prolonged release 135,844,746 L.L
R05FA01 NEO-CODION B Codeine Camphosulfonate - 25mg, Sulfogaiacol - 100mg, Grindelia soft extract - 20mg Tablet, coated 286,238 L.L
C09DB02 SEVIKAR B Olmesartan medoxomil - 40mg, Amlodipine - 5mg Tablet, film coated 1,158,392 L.L
D02AF REPARIL GEL-N B Diethylamine salicylate - 5g/100g, Ascine - 1g/100g Gel 481,096 L.L
G03CX01 LIVIAL B Tibolone - 2.5mg 2.5mg Tablet 1,135,547 L.L
H03BB02 TAPAZOLE B Methimazole (Thiamazole) - 5mg 5mg Tablet 565,694 L.L
L01CE01 HYCAMTIN IV B Topotecan HCl - 4mg 4mg Injectable lyophilised powder for solution 52,580,031 L.L
L01XK01 LYNPARZA B Olaparib - 150mg 150mg Tablet, film coated 230,789,350 L.L
M05BA08 ACLASTA B Zoledronic acid (monohydrate) - 5mg/100ml 5mg/100ml Injectable solution 21,075,062 L.L
N05AX13 BYANNLI B Paliperidone - 700mg 700mg Injectable suspension, prolonged release 93,221,562 L.L
R05FA02 TUSCALMAN A B Noscapine HCl - 5mg, Guaifenesin - 25mg Suppository 601,157 L.L
C09DB02 VOCADO B Olmesartan medoxomil - 40mg, Amlodipine besylate - 5mg Tablet, film coated 1,103,295 L.L
D02AX BIAFINE B Trolamine - 0.67g/100g 0.67g/100g Emulsion 524,099 L.L
G03DA03 PROLUTON DEPOT B Hydroxyprogesterone caproate - 250mg/ml 250mg/ml Injectable solution 270,112 L.L
H03BB02 THYROZOL B Methimazole (Thiamazole) - 5mg 5mg Tablet, film coated 233,829 L.L
L01XK04 TALZENNA B Talazoparib - 1mg 1mg Capsule 401,512,167 L.L
N03AX11 TOPAMAX B Topiramate - 100mg 100mg Tablet, film coated 3,471,145 L.L
R05FA02 TUSCALMAN B B Noscapine HCl - 10mg, Guaifenesin - 50mg Suppository 592,528 L.L
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