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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
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 1g/20ml 1g/20ml Injectable solution 7,474,948 L.L
J06BB01 IMMUNORHO BioHuman Human anti-D (rh) immunoglobulin - 300mcg 300mcg Injectable dry powder+diluent 5,794,649 L.L
J06BB01 RHOPHYLAC 300 BioHuman Human anti-D (rh) immunoglobulin - 300mcg/2ml 300mcg/2ml Injectable solution 5,939,784 L.L
J06BB01 RHESONATIV BioHuman Human anti-D (rh) immunoglobulin - 625IU/ml 625IU/ml Injectable solution 12,281,758 L.L
J06BB02 TETAGAM P BioHuman Human Tetanus Immunoglobulin - 250IU/ml 250IU/ml Injectable solution 2,958,325 L.L
J06BB02 TETANUS GAMMA BioHuman Human Tetanus Immunoglobulin - 250IU/ml 250IU/ml Injectable solution 3,077,399 L.L
J06BB04 IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB BioHuman Hepatitis B immunoglobulin (human) - 100UI/ml 100UI/ml Injectable solution 6,853,730 L.L
J06BB04 IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB BioHuman Hepatitis B immunoglobulin (human) - 500UI/5ml 500UI/5ml Injectable solution 26,599,935 L.L
J06BB05 RABISHIELD-100 (RABIES HUMAN MONOCLONAL ANTIBODY rDNA) BioHuman Rabies, Human IgG1 Monoclonal Antibody - 100IU/2.5ml 100IU/2.5ml 8,455,824 L.L
B02BB01 FIBRYGA BioHuman Fibrinogen, human - 1g 1g Injectable powder for solution+solvent 39,357,009 L.L
B02BB01 HAEMOCOMPLETTAN P BioHuman Fibrinogen, human - 1g 1g Injectable powder for solution 39,933,692 L.L
B02BB01 HAEMOCOMPLETTAN P BioHuman Fibrinogen, human - 2g 2g Injectable powder for solution 73,094,026 L.L
B02BD01 OCTAPLEX BioHuman Prothrombin complex, human (PPSB) - 500IU 500IU Injectable powder for solution+diluent 37,682,862 L.L
B02BD02 BERIATE BioHuman Coagulation Factor VIII - 250IU 250IU Injectable lyophilised powder for solution+diluent 13,561,486 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 250IU 250IU Injectable lyophilised powder for solution+diluent 13,247,110 L.L
B02BD02 BERIATE BioHuman Coagulation Factor VIII - 500IU 500IU Injectable lyophilised powder for solution+diluent 27,354,631 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 500IU 500IU Injectable lyophilised powder for solution+diluent 26,495,478 L.L
B02BD02 BERIATE BioHuman Coagulation Factor VIII - 1,000IU 1,000IU Injectable lyophilised powder for solution+diluent 47,481,122 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 1,000IU 1,000IU Injectable lyophilised powder for solution+diluent 46,817,511 L.L
B02BD03 FEIBA BioHuman Factor VIII Inhibitor bypassing fraction - 500IU 500U (50U/ml) Injectable powder for solution+solvent 38,938,709 L.L
B02BD03 FEIBA BioHuman Factor VIII Inhibitor bypassing fraction - 1000IU 1000U (50U/ml) Injectable powder for solution+solvent 76,827,220 L.L
B02BD04 IMMUNINE BioHuman Plasma coagulation factor IX, human - 600IU 600IU Injectable lyophilised powder for solution+diluent 20,506,214 L.L
B02BD04 OCTANINE F BioHuman Plasma coagulation factor IX, human - 500IU 500IU Injectable freeze dried powder + diluent 31,425,075 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
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 5g/50ml 5g/50ml Injectable solution 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
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 1200IU, Blood Coagulation Factor VIII - 500IU Injectable lyophilised powder for solution+diluent 33,698,319 L.L
J06BA02 CLAIRYG BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution L.L
B02BD06 WILATE 500 BioHuman Von Willebrand Factor - 500IU, Blood Coagulation Factor VIII - 500IU Injectable powder for solution+diluent 32,399,164 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 1200IU, Blood Coagulation Factor VIII - 500IU Injectable lyophilised powder for solution+diluent L.L
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