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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
L01CD04 CABAZITAXEL EVER PHARMA G Cabazitaxel - 60mg/6ml 10mg/ml Injectable concentrate for solution 51,622,917 L.L
L01CD04 CABAZITAXEL EVER PHARMA G Cabazitaxel - 60mg/6ml 10mg/ml Injectable concentrate for solution L.L
L01EX07 CABOMETYX B Cabozantinib - 20mg 20mg Tablet, film coated 401,478,618 L.L
L01EX07 CABOMETYX B Cabozantinib - 40mg 40mg Tablet, film coated 401,478,618 L.L
L01EX07 CABOMETYX B Cabozantinib - 60mg 60mg Tablet, film coated 401,478,618 L.L
L01DB01 CAELYX B Doxorubicin HCl pegylated liposomes - 20mg/10ml 20mg/10ml Injectable concentrated solution 31,708,528 L.L
L01DB01 CAELYX B Doxorubicin HCl pegylated liposomes - 20mg/10ml 20mg/10ml Injectable concentrated solution L.L
A11GB CAL-C-VITA EFFERVESCENT B Vitamin B6 - 15mg, Vitamin D - 300IU, Calcium carbonate - 625mg, Ascorbic acid - 1000mg Tablet, effervescent 494,534 L.L
A11AA CAL-VIT G Riboflavine - 9mg/100ml, Cyanocobalamine - 570mcg/100ml, Pyridoxine HCl - 35mg/100ml, Thiamine HCl - 190mg/100ml, Inositol - 150mg/100ml, Nicotinamide - 120mg/100ml, Calcium Pantothenate - 27mg/100ml, Sodium hypophosphite - 70mg/100ml Syrup 163,821 L.L
A11EA CAL-VIT G Riboflavine - 3mg, Cyanocobalamine - 60mcg, Pyridoxine HCl - 5mg, Thiamine mononitrate - 10mg, Inositol - 3mg, Calcium pantothenate - 3mg Tablet 142,063 L.L
A11EA CAL-VIT G Riboflavine - 3mg, Cyanocobalamine - 60mcg, Pyridoxine HCl - 5mg, Thiamine mononitrate - 10mg, Inositol - 3mg, Calcium Pantothenate - 3mg Tablet 4,025,128 L.L
D04AX CALAMINE PLUS B Diphenhydramine HCl - 0.25/100ml, Tetracaine HCl - 0.025/100ml, Zinc oxide - 8g/100ml, Calamine - 8g/100ml Lotion 177,899 L.L
B05XA07 CALCIUM CHLORIDE G Calcium chloride - 10g/100ml 10g/100ml Injectable solution 5,436,771 L.L
A12AA03 CALCIUM GLUCONATE G Calcium gluconate - 10g/100ml 10g/100ml Injectable solution 763,056 L.L
A12AA03 CALCIUM GLUCONATE G Calcium gluconate - 10g/100ml 10g/100ml Injectable solution 6,867,500 L.L
A12AA03 CALCIUM GLUCONATE S.A.L.F G Calcium gluconate monohydrate - 10% 10% Injectable solution 389,714 L.L
V03AE01 CALCIUM RESONIUM B Calcium Polystyrene Sulphonate - 15g 15g Powder 2,053,391 L.L
V03AF03 CALCIUMFOLINAT EBEWE G Calcium folinate - 100mg/10ml 100mg/10ml Injectable solution 1,289,872 L.L
R06AE09 CALIVIDA G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 447,948 L.L
R06AE09 CALIVIDA G Levocetirizine dihydrochloride - 0.5mg/ml 0.5mg/ml Solution 1,158,264 L.L
A12AA04 CALPEROS G Calcium (carbonate) - 500mg 500mg Tablet 630,262 L.L
A12AX CALPEROS D3 A SUCER B Vitamin D3 - 400IU, Calcium - 500mg Tablet, chewable 667,890 L.L
L01EL02 CALQUENCE B Acalabrutinib - 100mg 100mg Capsule 650,653,454 L.L
A12AA04 CALTRATE 600 B Calcium (carbonate) - 600mg 600mg Tablet 618,168 L.L
R03DA55 CAMPHO-PNEUMINE AMINOPHYLLINE ADULTES G Amyleine HCl - 0.01g, Eucalyptol - 0.05g, Camphre - 0.1g, Gaiacol ethyl glycolate - 0.26g, Aminophylline - 0.15g Suppository 326,362 L.L
R03DA55 CAMPHO-PNEUMINE AMINOPHYLLINE ADULTES G Amyleine HCl - 0.01g, Eucalyptol - 0.05g, Camphre - 0.1g, Gaiacol ethyl glycolate - 0.26g, Aminophylline - 0.15g Suppository 490,183 L.L
R03DA55 CAMPHO-PNEUMINE AMINOPHYLLINE ENFANTS G Eucalyptol - 0.03g, Camphre - 0.04g, Gaiacol ethyl glycolate - 0.12g, Aminophylline - 0.06g Suppository 284,127 L.L
R03DA55 CAMPHO-PNEUMINE AMINOPHYLLINE ENFANTS G Eucalyptol - 0.03g, Camphre - 0.04g, Gaiacol ethyl glycolate - 0.12g, Aminophylline - 0.06g Suppository 426,190 L.L
G01AF02 CANAGYN G Clotrimazole - 100mg 100mg Tablet 229,797 L.L
G01AF02 CANAGYN G Clotrimazole - 500mg 500mg Tablet 302,365 L.L
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