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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
M03BX02 SIRDALUD B Tizanidine HCl - 4mg 4mg Tablet 826,175 L.L
N05AX08 RISPERDAL B Risperidone - 1mg 1mg Tablet, film coated 306,396 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
C07AG02 DILATREND B Carvedilol - 6.25mg 6.25mg Tablet, scored 364,181 L.L
D01AE14 MYCOSTER B Ciclopirox - 8g/100g 8% Film forming solution 756,583 L.L
L01BC08 DACOGEN B Decitabine - 50mg 50mg Injectable lyophilised powder for solution 87,048,758 L.L
M03BX04 MYDOCALM B Tolperisone - 150mg 150mg Tablet, film coated 839,902 L.L
N05AX08 RISPERDAL B Risperidone - 1mg 1mg Tablet, film coated 306,396 L.L
A10BA02 GLUCOPHAGE XR B Metformin HCl - 500mg 500mg Tablet, prolonged release 465,968 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
C09DA08 VOTUM PLUS B Olmesartan medoxomil - 20mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 900,374 L.L
D01AE14 MYCOSTER B Ciclopirox - 8g/100g 8% Film forming solution 756,583 L.L
L01BC08 DACOGEN B Decitabine - 50mg 50mg Injectable lyophilised powder for solution 87,048,758 L.L
N06DX01 EBIXA B Memantine - 20mg 20mg Tablet, film coated 4,004,651 L.L
A16AB02 CEREZYME B Imiglucerase - 400IU 400IU Injectable lyophilised powder for solution 128,412,818 L.L
B05BA01 AMINOPLASMAL B. BRAUN B Amino acids - 10% 10% Injectable solution 1,036,103 L.L
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L01BC59 LONSURF B Trifluridine - 20mg, Tipiracil - 8.19mg Tablet, film coated 75,019,126 L.L
S01GA51 NAPHCON A B Naphazoline HCl - 0.025%, Pheniramine maleate - 0.3% Drops solution 369,557 L.L
C07AG02 DILATREND B Carvedilol - 25mg 25mg Tablet, scored 598,010 L.L
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 12.5mg Tablet, film coated 1,846,440 L.L
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H02AB04 SOLU MEDROL B Methylprednisolone sodium succinate - 500mg 500mg Injectable powder for solution 718,956 L.L
J02AC03 VFEND B Voriconazole - 200mg 200mg Tablet, film coated 51,904,550 L.L
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M04AA01 ZYLORIC B Allopurinol - 100mg 100mg Tablet 278,175 L.L
N02CC04 MAXALT B Rizatriptan (benzoate) - 10mg Tablet 439,436 L.L
R03DX10 FASENRA B Benralizumab - 30mg 30mg Injectable solution 214,213,273 L.L
A16AB05 ALDURAZYME B Laronidase - 100U/ml 100U/ml Injectable concentrate for solution 57,138,680 L.L
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