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UgandaNational Drug Authority
Uganda Government, Ministryy of Finance, Planning and Economic Development
National Drug Authority Secretariat
REC or IRB responsible for ethical assessment of clinical trial applications?
Uganda National Council for Science and Technology
Pays
Uganda
URL de l'institution
http://www.nda.org.ug
Type d'organisation
National
Quelle est l'affiliation institutionnelle de votre organisation
Government
What is the operational language(s) of your MRA/DRA?
English
Votre comité d'éthique / comité d'éthique indépendant dispose-t-il d'un budget alloué
From what sources does the research budget come?
National government, Fees for Services
Name of the CEO/DIRECTOR/HOD
Mr Sematiko Gordon
Gender of the CEO/DIRECTOR/HOD: M
Age of group of the CEO/DIRECTOR/HOD: 50 - 60
Telephone of the CEO/DIRECTOR/HOD
+256 414255665
Email of the CEO/DIRECTOR/HOD
ndaug@nda.or.ug
Administrator's name or contact person
Dr.Evans Tusubira
Administrator's name or contact person E-mail
E2tusubira@gmail.com
Numéro de téléphone: +256 414255665
Numéro de fax: +256 41 255758
Adresse postale
46/47 Lumumba Avenue,
Kampala
Adresse physique
National Drug Authority,
P.O. Box 23096,
Kampala'
Uganda
Quel est votre mode de réception préféré pour des protocoles: All the above
Application fee is required?: Yes
How often are the review meetings?: monthly
Stipulated deadlines for submission of applications?
No deadlines stipulated
Approximately what is the time frame for response to an application?
Two months after a convened meeting
Is the review fee fixed for all applicants or is it negotiable? No
If so, please describe the process briefly
The fee ranges from $1000-$4000 but it can be waived in special cases like for students not supported by University or Industry.
Which categories of medicines need approval before conducting a clinical trial?: Unregistered medicines, Registered medicines - Indications(s) and clinical use, Registered medicines - Target patient population(s), Registered medicines - Route(s) of administration, Registered medicines - Dosage regimen(s)
Year of establishment of the organisation 1993
Does your MRA have a secretariat with a full-time administrator? Yes
Does your MRA have units or sub-committees? Yes
If yes, please list the committees or sub-committees:
1. Licencing
2. Herbal Clinical Trials
3.Medical Devices
4.Public Health Products
Is your MRA autonomous or semi-autonomous? Autonomous
Please briefly summarize the major functions of your MRA regarding the regulation and control of the conduct of clinical trials in your country (Expand space as required)
Authorization, monitoring and control of research products
Est-ce-que votre MRA fait parfois appel à des évaluateurs externes pour l'évaluation des protocoles d'essais cliniques? Yes
Si oui, font-ils appel à des évaluateurs locaux, régionaux ou internationaux?
Local
Which of the following pharmaceutical products require your MRAÂ’s authorization for use in clinical trials?
Drugs, Diagnostics, Therapy protocols, Traditional & Complimentary Medicines
Does your MRA conduct clinical trial audits and monitoring? Yes
Est-ce-que votre MRA collabore/partage ses analyses avec certains Comités d'éthique pour la recherche? No
Do any of your MRA members have specialist training and experience in any of the following?: Clinical Trials, Research Ethics, Epidemiology, Statistics
Please indicate if your staff members are given the opportunity to attend the following capacity building trainings regarding the review of clinical trial protocols?: Conferences, Workshops
Votre comité d'éthique / comité d'éthique indépendant dispose-t-il d'un budget alloué Yes
From what sources does the research budget come?: National government, Fees for Services
Does your MRA have a comprehensive electronic Information Management System for creation, storage and retrieval of document? Yes
How is the information you gather stored? Manually,Electronically
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