Chapter III
CONDITIONS OF CLINICAL DRUG TRIAL
Article 9. Conditions for drugs of clinical trial
Drugs of clinical trials must meet the following requirements:
1. Have been researched in pre-clinical stage; have documents to prove the safety to be able to test the next stages.
2. Have formulations, dosage forms and stabled dosage process.
3. Have results of clinical trial studies of the previous stages if it is proposed clinical drug trial for the next stages.
4. Get standards of quality according to registration dossier for clinical drugs trial.
5. Medicine label of clinical trial with the words "Product used for clinical trial; it is forbidden to use for other purposes."
Article 10. Conditions on dossiers of clinical trial
Dossier of registration for clinical trial is in Vietnamese (01 original with signature, legal stamp and 03 copies), including:
1. Application for clinical drug trial of agencies, organizations and individuals with drugs requesting for clinical trial (Appendix 1 attached to this Circular).
2. Dossiers of products for researchers in Vietnamese or in English accompanied by a summary in Vietnamese (Appendix 2 attached herewith).
3. Application for evaluation and research proposals approved clinical trial of institutions undertaking test (Appendix 3 attached to this Circular).
4. Cooperation contract of researching clinical drug trial among agencies, organizations, individuals with drugs requested for clinical trial and organizations undertaking trial and cooperation contracts between agencies, organizations and individuals with drugs requested for clinical trial and clinical research organization, clinical site management organization if any (Annex 4, issued together with this Circular).
5. Explanation for the research scheme of clinical trial (Appendix 5, issued together with this Circular).
6. Scientific curriculum vitae and certificates of good clinical practice of the prime researcher/subject chairman issued by the Health Ministry or by organizations recognized by the Health Ministry.
7. The written provision of information on research and slip of volunteer participating in the research (Appendix 6, issued together with this Circular).
8. Minute of evaluating the science and ethics in research of the ethics Council in biomedical research of basic level (organization undertaking clinical drugs trial).
9. Written certification of the participation of research institutions over multi-center research in Vietnam.
10. Written approval of the research of People’s Committee of province or city directly under the Central Government for research in the field.
11. The documents on the clinical drugs trial include:
a) Drug researching documents recipe ingredients, production processes, quality standards, drug testing slip (for pharmaceutical drugs, traditional medicines or drugs from medicinal plants: testing slip of the agency of central drug testing or of the manufacturers achieved standards of good manufacturing practice (GMP); for vaccines: quality testing slip of national testing agencies or certification of shipments for lot of vaccines, biological products of the National Drug Administration of home country).
b) Document of pre-clinical research of drugs need to be tested: reports of research on the pharmacological effects, toxicity, safety and suggestions on dosage, route of administration, use.
c) Research documents of clinical drug trial of the previous stages (if it is proposed clinical drug trial for the next stages).
12. A certified copy of the certificate of product (CPP) or permit for the circulation of drugs (FSC) and certificate of achieving standards of good manufacturing practice (GMP) of the competent State management agencies for drugs suggested for research of clinical trials, evaluating the safety, clinical trial of stage 4.
13. Label of research drug as prescribed in Clause 5 of Article 9 of this Circular and photos of samples of research drugs.
Article 11. Conditions of institutions undertaking clinical trial, the prime researchers and researchers participating in clinical drug trial
1. Organizations undertaking clinical drug trial must meet the criteria of good clinical practice (GCP); be independent of economy, of personnel organization against individuals and organizations with drugs of clinical trial and commit that the clinical trial totally do not have any conflicts of interest between the parties.
2. Pime researchers in the clinical trial must have the level of specialized knowledge, clinical experience, practical ability to ensure the principles of good clinical practice, master the rules of clinical drugs trial, capable of implementing the research outline which was approved in full and on schedule, with GCP certificate issued by the Ministry of Health or by organizations recognized by the Health Ministry.
3. Researcher must have appropriate expertise, to be trained in the necessary contents and skills to undertake research, have GCP certificate issued by the Ministry of Health or by organizations recognized by the Health Ministry.
Article 12. Conditions of participants of clinical drug trial
1. Participants in clinical drug trial must be volunteers meeting professional requirements and must sign a commitment with the organization undertaking clinical dugs trial, except for those who are restricted civil act capacity, lose civil act capacity or have no capacity for civil acts.
2. Where the participants in clinical drug trial are less than 18 years old, restricted civil act capacity, lost civil act capacity or have no capacity for civil acts, it must be approved by their representatives in accordance with the law provisions.
3. Where the participants in clinical drug trial are women who are pregnant or breast-feeding: research dossiers must be clearly stated the reasons for selecting this subject and must be approved by the Minister of Health on the basis of consideration and evaluation of research outline for scientific, moral aspects of the Council of Ethics in biomedical research - Ministry of Health.
Article 13. Conditions for funding clinical drug trial
1. Funding must be sufficient to complete the activities in the whole process of clinical drug trial (including items: funding for conducting research and funding for management, supervision, inspection) funded by the agencies, organizations and individuals with drugs of clinical trial shown by research contracts between agencies, organizations, individuals with drugs of clinical trial and organizations undertaking clinical drug trials.
2. For the study drugs funded by the program, themes using the state budget or the themes in cooperation with other foreign and domestic organizations and individuals, chairmen and organizations undertaking clinical drug trial need to estimate funds for clinical trials in total funds allocated for research.
3. Organizations undertaking clinical testing and researchers are responsible for managing their allocated funds to spend on research with the proper content and cost norms prescribed by law or contract signed by both parties.
Tìm kiếm
Thông tư 03/2012/TT-BYT (Bản Word)