Register for clinical trials
-ministry of health portal-
Procedure
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Register for clinical trials
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The order of execution
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Step 1: Agencies, organizations and individuals that have clinical drugs submit their registration profiles to the Ministry of Health.
Step 2: Within 15 working days after receiving the registration profiles, the Ministry of Health shall issue a written reply, which shall serve as basis for agencies, organizations and individuals that have clinical drugs to deploy next step.
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How to perform
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Post or submitted directly to the administrative offices
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Composition, number of records
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a. A profile including:
1. The application for clinical drug testing by an agency, organization or individual that has clinical drug (Appendix 1)2. Product profiles for researchers in Vietnamese or in English, accompanied by a summary in Vietnamese (Appendix 2)
b) Number of documents: 01 original signed, legally sealed and 03 copies
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Term of settlement
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15 days after receiving a complete and valid file
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Persons are allowed to carry out administrative procedures
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Individuals, organizations
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Agency implementing administrative procedures
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Administration of science technology and training
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Results of implementation of administrative procedures
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Profile approved
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Fees (if applicable)
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Non
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Form name, Declaration form name (Attached to this procedure)
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The form proposed clinical trial of drugs
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Product profile for researchers
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Requirements and conditions for carrying out administrative procedures (if any)
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Clinical reagent must satisfy the following requirements:
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Has been studied in the preclinical phase, there are documents to prove safety to be able to test the next stage.
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Have formulas, dosage forms and preparation process stable.
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Results of previous clinical trials are available if the clinical trial is recommended for the next stage.
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Satisfying quality standards according to clinical trial registration profiles.
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Labels of clinical drugs with text:" Products are used for clinical trials. Banned for other purposes".
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Source: Click here!