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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
N03AG04 SABRIL B Vigabatrin - 500mg 500mg Tablet, film coated 2,988,706 L.L
A10BH01 SAGIFOR G Sitagliptin (HCl monohydrate) - 100mg 100mg Tablet, film coated 1,242,606 L.L
A10BD07 SAGIMET G Metformin HCl - 1000mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,551,690 L.L
A10BD07 SAGIMET G Metformin HCl - 500mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,432,536 L.L
A10BD07 SAGIMET G Metformin HCl - 850mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,463,892 L.L
L01EA01 SAGITTA G Imatinib - 400mg 400mg Capsule, hard 51,723,840 L.L
L01EA01 SAGITTA G Imatinib - 100mg 100mg Capsule, hard 25,170,264 L.L
J01DE01 SALAPIME G Cefepime - 1g 1g Injectable powder for solution 618,168 L.L
R03AC02 SALBUTAMOL SULFATE G Salbutamol (sulfate) - 2mg 2mg Tablet, scored 401,873 L.L
A07EC02 SALCROZINE G Mesalazine - 500mg 500mg Tablet, gastroresistant 2,013,076 L.L
A07EC02 SALCROZINE G Mesalazine - 1g 1g Tablet, gastroresistant 4,073,187 L.L
A07EC02 SALCROZINE G Mesalazine - 500mg 500mg Suppository 576,508 L.L
A07EC02 SALCROZINE G Mesalazine - 1000mg 1000mg Suppository 2,306,034 L.L
A07EC02 SALOFALK B Mesalazine - 500mg 500mg Tablet, enteric coated 2,874,479 L.L
A07EC02 SALOFALK B Mesalazine - 1000mg 1000mg Granules, gastro-resistant, prolonged release 3,874,298 L.L
A07EC02 SALOFALK B Mesalazine - 1g 1g Suppository 3,948,209 L.L
A07EC02 SALOFALK B Mesalazine - 4g/60ml 4g/60ml Enema 3,796,355 L.L
A07EC02 SALOFALK B Mesalazine - 1.5g 1.5g Granules, gastro-resistant, prolonged release 6,150,767 L.L
A07EC02 SALOFALK B Mesalazine - 3g 3g Granules, gastro-resistant, prolonged release 11,256,652 L.L
A07EC02 SALOFALK 500 B Mesalazine - 500mg 500mg Suppository 677,297 L.L
A02BC01 SANAMIDOL G Omeprazole - 20mg 20mg Capsule 456,906 L.L
A04AA02 SANCUSO G Granisetron - 3.1mg/24h 3.1mg/24h Patch 7,590,728 L.L
L04AD01 SANDIMMUN B Ciclosporin - 50mg/ml 250mg/5ml Injectable concentrated solution 6,992,013 L.L
L04AD01 SANDIMMUN NEORAL B Ciclosporin - 100mg/ml 100mg/ml Solution 8,264,592 L.L
L04AD01 SANDIMMUN NEORAL SOFT GELATIN B Ciclosporin - 50mg 50mg Capsule, soft gelatin 4,309,703 L.L
L04AD01 SANDIMMUN NEORAL SOFT GELATIN B Ciclosporin - 25mg 25mg Capsule, soft gelatin 2,385,320 L.L
L04AD01 SANDIMMUN NEORAL SOFT GELATIN B Ciclosporin - 100mg 100mg Capsule, soft gelatin 8,264,592 L.L
H01CB02 SANDOSTATIN B Octreotide - 0.1mg/ml 0.1mg/ml Injectable solution 1,038,790 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent 37,210,097 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent 50,180,905 L.L
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