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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
A10AB01 ACTRAPID BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 752,552 L.L
A10AB01 ACTRAPID BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 752,552 L.L
A10AB06 APIDRA SOLOSTAR BioTech Insulin glulisine - 100IU/ml 100IU/ml Injectable solution 3,942,834 L.L
A10AB06 APIDRA BioTech Insulin glulisine - 100IU/ml 100IU/ml Injectable solution 2,221,372 L.L
M05BA08 ACLASTA B Zoledronic acid (monohydrate) - 5mg/100ml 5mg/100ml Injectable solution 21,075,062 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 10,000IU 10000IU Injectable solution 4,036,903 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 10,000IU 10,000IU Injectable solution 10,661,285 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 8,728,144 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 1,127,036 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 4,748,244 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable solution 11,210,836 L.L
M01AB05 ALMIRAL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 415,247 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
L04AB01 ALTEBREL BioTech Etanercept - 50mg/1ml 50mg/1ml Injectable solution 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
M01AB15 ALGIKEY G Ketorolac trometamine - 30mg/ml 30mg/ml Injectable solution 873,498 L.L
N01BB58 ARTINIBSA 4% WITH EPINEPHRINE 1/100000 B Articaine HCl - 4%, Epinephrine - 1/100.000 Injectable solution 2,082,956 L.L
N01BB58 ARTICAINE MEDIS ADRENALINE G Articaine HCl - 40mg/ml, Adrenaline - 0.07mg/ml Injectable solution 1,881,380 L.L
A03BA01 ATROPINE SULFATE RENAUDIN G Atropine sulfate - 1mg/ml 0.1% Injectable solution 397,777 L.L
A03BA01 ATROPINE G Atropine sulfate - 1mg/ml 1mg/ml Injectable solution 702,149 L.L
A03BA01 ATROPINE I.V. 0.25 MG. G Atropine - 0.25mg/ml 0.25mg/ml Injectable solution 2,412,129 L.L
A03BA01 ATROPINE SULFATE RENAUDIN G Atropine sulfate - 0.5mg/ml 0.5mg Injectable solution 385,683 L.L
A03BA01 ATROPINE G Atropine sulfate - 0.5mg/ml 0.5mg/ml Injectable solution 680,315 L.L
A03BA01 ATROPINE SULFATEAGUETTANT G Atropine - 0.1mg/ml 0.1mg/ml Injectable solution 7,805,376 L.L
A03BB01 ANTIPAN G Hyoscine N butylbromide - 20mg/ml Injectable solution 355,798 L.L
A03BB01 ANTIPAN G Hyoscine N butylbromide - 20mg/ml Injectable solution 2,557,140 L.L
J06BA02 ARAGAM BioHuman Human normal immunoglobulin - 5g/100ml 5g/100ml Injectable solution 36,492,913 L.L
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