Update: 17/08/2017
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Register for clinical trials
                                                                                                      -ministry of health portal-

Procedure

Register for clinical trials

The order of execution

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.

How to perform

Post or submitted directly to the administrative offices

Composition, number of records

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

Term of settlement

15 days after receiving a complete and valid file

Persons are allowed to carry out administrative procedures


Individuals, organizations

Agency implementing administrative procedures


Administration of science technology and training

Results of implementation of administrative procedures

 

Profile approved

Fees (if applicable)

Non

Form name, Declaration form name (Attached to this procedure)

  1. The form proposed clinical trial of drugs
  2. Product profile for researchers

Requirements and conditions for carrying out administrative procedures (if any)

Clinical reagent must satisfy the following requirements:

  1. Has been studied in the preclinical phase, there are documents to prove safety to be able to test the next stage.
  2. Have formulas, dosage forms and preparation process stable.
  3. Results of previous clinical trials are available if the clinical trial is recommended for the next stage.
  4. Satisfying quality standards according to clinical trial registration profiles.
  5. Labels of clinical drugs with text:" Products are used for clinical trials. Banned for other purposes".
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