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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
A03AA04 SPASMINE (Mebeverine HCl 200mg SR) G Mebeverine HCl - 200mg 200mg Capsule, slow release 712,876 L.L
A03AA04 BEVACOL 135 G Mebeverine HCl - 135mg 135mg Tablet, film coated 532,162 L.L
A03AB02 GLYCOPYRROLATE B Glycopyronium Bromide - 0.2mg/ml 0.2mg/ml Injectable solution 7,238,185 L.L
A03AB06 SPASMOMEN B Otilonium bromide - 40mg 40mg Tablet, coated 438,093 L.L
A03AB06 NOSPAZM G Otilonium bromide - 40mg 40mg Tablet, film coated 282,207 L.L
A03AX COLPERMIN B Pepermint oil - 187mg 187mg Capsule, delayed release 632,950 L.L
A03AX HEPABYL G Sorbitol - 2.5g/5ml, Diisopromine - 0.02g/5ml Liquid 238,052 L.L
A03AX SPASMO-DIGESTIN B Simethicone - 30mg, Dicyclomine HCl - 5mg, Sodium dihydrocholate - 10mg, Sanzyme 3500 - 36mg, Papain - 100mg Tablet, enteric coated 260,705 L.L
A03AX12 SPASFON B Phloroglucinol hydrate - 80mg, Trimethylphloroglucinol - 80mg Tablet, coated 278,175 L.L
A03AX12 PHLOROGLUCINOL/TRIMETHYLPHLOROGLUCINOL ARROW G Phloroglucinol - 40mg/4ml, Trimethylphloroglucinol - 0.04mg/4ml Injectable solution 940,690 L.L
A03AX13 OVOL B Simethicone - 40mg/ml 40mg/ml Drops 233,829 L.L
A03AX13 SIMETHICONE G Dimethicone - 2g/100ml 2g/100ml Emulsion 212,327 L.L
A03AX13 OVOL FOR GAZ B Simethicone - 180mg 180mg Capsule, liquid gel 241,892 L.L
A03AX13 MOSAR PLUS B Mosapride citrate - 5mg, Simethicone - 200mg Tablet, coated 865,435 L.L
A03AX58 METEOSPASMYL B Alverine citrate - 60mg, Simethicone - 300mg Capsule 481,096 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 BUSCOPAN B Butylscopolamine bromide - 10mg 10mg Tablet, sugar coated 692,079 L.L
A03BB01 BUSCOPAN B Butylscopolamine bromide - 10mg 10mg Tablet, sugar coated 291,614 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 10mg 10mg Tablet, film coated 162,605 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 5mg/5ml 5mg/5ml Syrup 210,983 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 178,731 L.L
A03BB01 SCOBUREN G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 370,901 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
A03CA02 FLUDINIUM G Clidinium bromide - 2.5mg, Trifluoperazine HCl - 1mg Capsule 386,515 L.L
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