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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
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 4,748,244 L.L
B03XA01 EPOTIN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU/ml 4,000IU/ml Injectable solution 11,317,795 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 940,690 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 33,852,747 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10,000IU 10,000IU Injectable freeze dried substance+diluent 2,490,140 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 20,000IU 20,000IU Injectable freeze dried powder + diluent 5,438,531 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable solution 11,210,836 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable freeze dried powder + diluent 6,316,060 L.L
B03XA06 REBLOZYL BioTech Luspatarcept - 25mg 25mg Injectable powder for solution 125,960,784 L.L
B03XA06 REBLOZYL BioTech Luspatercept - 75mg 75mg Injectable powder for solution 377,881,318 L.L
B05 20 MEQ POTASSIUM OF 5% DEXTROSE AND 0.45% SODIUM CHLORIDE INJECTION USP B Dextrose, H2O - 5%, Sodium chloride - 0.45%, Potassium chloride - 20meq Injectable solution 229,959 L.L
B05 20 MEQ POTASSIUM OF 0.9% SODIUM CHLORIDE INJECTION USP B Sodium chloride - 0.9%, Potassium chloride - 20meq Injectable solution 278,102 L.L
B05 20 MEQ POTASSIUM OF 0.9% SODIUM CHLORIDE INJECTION USP B Sodium chloride - 0.9%, Potassium chloride - 20mEq Injectable solution 229,959 L.L
B05 SOLUFLEX POTASSIUM CHLORIDE 40meq/l SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9%, Potassium chloride - 40meq/l Injectable solution 293,041 L.L
B05 SOLUFLEX POTASSIUM CHLORIDE 20meq/l SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9%, Potassium chloride - 20meq/l Injectable solution 232,134 L.L
B05AA01 ALBUTEIN BioHuman Human Albumin - 20% 20% Injectable solution 7,154,928 L.L
B05AA01 ALBUTEIN BioHuman Human Albumin - 20% Injectable solution 4,031,528 L.L
B05AA01 HUMAN ALBUMIN "OCTAPHARMA" 20% BioHuman Albumin human - 20% 20% Injectable solution 4,863,366 L.L
B05AA01 HUMAN ALBUMIN 20% SOLUTION BioHuman Albumin human - 20% 20% Injectable solution 4,177,896 L.L
B05AA01 HUMAN ALBUMIN BEHRING 20%, LOW SALT BioHuman Albumin human - 20% 20% Injectable solution 4,177,896 L.L
B05AA01 PLASBUMIN-20 ALBUMIN (HUMAN) BioHuman Albumin human - 20% 20% Injectable solution 3,641,813 L.L
B05AA01 UMAN ALBUMIN BioHuman Albumin human - 20g/100ml 10g/50ml Injectable solution 3,598,810 L.L
B05AA01 VIALEBEX BioHuman Albumin human - 200g/L 200g/L Injectable solution 3,417,391 L.L
B05AA01 YDRALBUM 200G/L BioHuman Albumin human - 10g/50ml Injectable solution 3,417,391 L.L
B05AA06 GELASPAN B Gelatine, succinylated - 4% 4% Injectable solution 9,107,572 L.L
B05AA07 VOLUVEN B Starch poly(O-2-Hydroxyethyl) - 6% 6% Injectable solution 987,724 L.L
B05BA01 AMINOVEN 10% B Glacial Acetic Acid 99% - 5.297g/l, L-Proline - 15.0g/l, L-Alanine - 15.0g/l, Glycine - 14.0g/l, L-Histidine - 3.00g/l, L-Arginine - 12.0g/l, L-Valine - 6.20g/l, L-Tryptophan - 2.00g/l, L-Threonine - 4.40g/l, L-Phenylalanine - 5.10g/l, L-Methionine - 4.30g/l, L-Lysine (monoacetate) - 6.60g/l, L-Leucine - 7.40g/l, L-Isoleucine - 5.00g/l Injectable solution 951,440 L.L
B05BA01 AMINOVEN INFANT B L-Leucine - 13g/l, L-Isoleucine - 8g/l, L-Lysine Acetate - 12g/l, L-Methionine - 3.12g/l, L-Phenylalanine - 3.75g/l, L-Threonine - 4.40g/l, L-Tryptophan - 2.01g/l, L-Valine - 9g/l, Arginine - 7.5g/l, L-Histidine - 4.76g/l, Glycine - 4.15g/l, L-Taurine - 0.40g/l, L-Serine - 7.67g/l, L-Alanine - 9.3g/l, L-Proline - 9.71g/l, N-Acetyl-L-Tyrosine - 5.176g/l, N-Acetyl-L-Cysteine - 0.70g/l, L-Malic Acid - 2.62g/l 10% Injectable solution 880,217 L.L
B05BA01 AMINOPLASMAL B. BRAUN B Amino acids - 10% 10% Injectable solution 1,036,103 L.L
B05BA02 SMOFLIPID G Soya oil - 6%, Olive oil - 5%, Fish oil - 3%, Medium chain triglycerides - 6% 20% Injectable emulsion 1,424,473 L.L
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