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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
C05AX05 PROCTO GLYVENOL B Lidocaine - 40mg, Tribenoside - 400mg Suppository 399,121 L.L
N02BE51 PANADOL SINUS B Paracetamol - 500mg, Pseudoephedrine HCl - 30mg Caplet 228,453 L.L
S01ED51 COMBIGAN 2mg/ml 5mg/ml B Timolol - 5mg/ml, Brimonidine tartrate - 2mg/ml Drops solution 1,181,238 L.L
C05AX05 PROCTO GLYVENOL B Lidocaine HCl - 2g/100g, Tribenoside - 5g/100g Cream 405,840 L.L
N02BE51 ALGIN ADULTS G Paracetamol - 400mg, Caffeine - 50mg Suppository 195,817 L.L
S01ED51 COMBIGAN 2mg/ml 5mg/ml B Timolol - 5mg/ml, Brimonidine tartrate - 2mg/ml Drops solution 1,181,238 L.L
C05BA53 CONTRACTUBEX B Allantoin - 1g/100g, Cepae - 10g/100g, Heparin - 5000IU/100g Gel 498,566 L.L
D10AF51 DUAC ONCE DAILY B Clindamycin (phosphate) - 1%, Benzoyl peroxide - 5% Gel 1,658,302 L.L
L01BA04 PEMETREXED NEAPOLIS G Pemetrexed (disodium) - 500mg Injectable powder 41,289,202 L.L
N02BE51 PANADOL COLD & FLU DAY B Paracetamol - 500mg, Caffeine - 25mg, Phenylephrine HCl - 5mg Caplet 284,895 L.L
S01ED51 GANFORT B Timolol maleate - 5mg/ml, Bimatoprost - 300mcg/ml Drops solution 950,097 L.L
C05BA53 CONTRACTUBEX B Allantoin - 1g/100g, Cepae - 10g/100g, Heparin - 5,000IU/100g Gel 1,183,925 L.L
G04CA52 DUTAMSUVITAE G Tamsulosin HCl - 0.4mg, Dutasteride - 0.5mg Capsule, hard 2,168,962 L.L
N02BE51 PANADOL COLD & FLU ALL IN ONE B Paracetamol - 250mg, Guaifenesin - 100mg, Phenylephrine HCl - 5mg Tablet, film coated 342,680 L.L
S01ED51 GANFORT B Timolol maleate - 5mg/ml, Bimatoprost - 300mcg/ml Drops solution 950,097 L.L
G04CA52 DUTASTERIDE/TAMSULOSINE ARROW G Tamsulosin HCl - 0.4mg, Dutasteride - 0.5mg Capsule 1,337,123 L.L
N02BE51 SOLPADEINE B Paracetamol - 500mg, Caffeine - 30mg, Codeine - 8mg Tablet 319,835 L.L
S01ED51 DUOTRAV B Timolol (maleate) - 5mg, Travoprost - 40mcg Drops solution 1,933,789 L.L
G04CA53 VESOMNI B Tamsulosin HCl - 0.4mg, Solifenacin succinate - 6mg Tablet, modified release 4,491,122 L.L
N02BE51 SOLPADEINE SOLUBLE B Paracetamol - 500mg, Caffeine - 30mg, Codeine - 8mg Tablet, effervescent 272,800 L.L
S01ED51 TRAVOPROST/TIMOLOL BIOGARAN G Travoprost - 40mcg/ml, Timolol - 5mg/ml Drops solution 849,308 L.L
N02BE51 SOLPEX G Paracetamol - 500mg, Caffeine - 30mg, Codeine - 8mg Tablet 243,172 L.L
S01ED51 LOPROSTAN G Timolol - 5mg/ml, Latanoprost - 50?g/ml Drops 768,678 L.L
N02BE51 PANADOL COLD & FLU VAPOUR RELEASE + DECONGESTANT B Paracetamol - 600mg, Phenylephrine HCl - 10mg Powder for solution 524,099 L.L
S01ED51 COMBISOPT G Timolol maleate - 5mg/ml, Dorzolamide HCl - 20mg/ml Drops solution 935,570 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 600IU, Blood Coagulation Factor VIII - 250IU Injectable lyophilised powder for solution+diluent 14,117,737 L.L
N02BE51 MAXIFEN G Paracetamol - 325mg, Ibuprofen - 400mg Tablet, scored 225,254 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 2400IU, Blood Coagulation Factor VIII - 1000IU Injectable lyophilised powder for solution+diluent 49,643,758 L.L
C05BX51 DOXIPROCT B Calcium dobesilate - 4%, Lidocaine HCl - 2% Ointment 610,104 L.L
N02BE51 GENTLE RELIEF G Paracetamol - 325mg, Ibuprofen - 400mg, Famotidine - 20mg Tablet 184,106 L.L
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