Chương 8 Luật Dược 2005: Thử thuốc trên lâm sàng

Chapter VIII

CLINICAL TRIALS

Article 54.- Drugs subject to clinical trial

1. New drugs must be clinically tried.

2. Drugs subject to clinical trial must satisfy the following requirements:

a/ Having already been studied in the pre-clinical stage;

b/ Having a stable preparation form;

c/ Being up to the quality standards according to their clinical trial registration dossiers.

3. Labels of drugs subject to clinical trial must have the words "Product for clinical trial. Its use for other purposes is prohibited."

Article 55.- Drugs exempt from clinical trial

1. Drugs in their original names.

2. Foreign drugs which have not yet been granted numbers of registration in Vietnam but have already been lawfully circulated for at least five years in such foreign countries; have been widely used for many patients and certified as safe and effective by competent state agencies of the countries of manufacture; have the same way of taking, the same concentrations and indications in Vietnam identical to indications in such countries.

3. Traditional medicine recipes already recognized by the Health Ministry.

4. The Health Minister shall specify cases where drugs are exempt from clinical trial or exempt from a number of clinical trial stages.

Article 56.- Conditions of clinical trial participants

1. Clinical trial participants must be volunteers, satisfy professional requirements and enter into contracts with organizations undertaking to conduct clinical trials, except for those who have restricted civil act capacity, lost civil act capacity or no civil act capacity.

2. Where clinical trial participants are minors or persons who have restricted civil act capacity or lost civil act capacity, their representatives' consent is required according to the provisions of law.

3. The Health Minister shall specify cases where clinical trial participants are pregnant women.

Article 57.- Rights of clinical trial participants

1. To be supplied with sufficient and truthful information on clinical trials before such trials are conducted and possible risks.

2. To be compensated for damage, if any, caused by clinical trials by organizations or individuals having drugs subject to clinical trial.

3. To have their relevant personal information kept secret.

4. To be free from liability for unilateral termination of contracts for participation in clinical trials.

5. To lodge complaints or denunciations about law violations by organizations or individuals having drugs subject to clinical trial or undertaking to conduct clinical trial.

Article 58.- Rights of organizations or individuals having drugs subject to clinical trial

1. To select organizations satisfying requirements on material foundations and professional personnel for clinical trial of drugs.

2. To own all research results of clinically tried drugs.

Article 59.- Obligations of organizations and individuals having drugs subject to clinical trial

1. To apply for written permits of the Health Minister before clinical trials are conducted.

2. To pay damages to clinical trial participants for risks caused by clinical trials according to the provisions of law.

3. To enter into contracts for clinical trials of drugs with organizations undertaking to conduct such trials.

Article 60.- Rights of organizations undertaking to conduct clinical trials of drugs

1. To be supplied with drugs and money by organizations and individuals having drugs subject to clinical trial strictly according to the provisions of law.

2. To use research results of clinical trials of drugs according to agreements with organizations or individuals having drugs subject to clinical trial.

Article 61.- Obligations of organizations undertaking to conduct clinical trials of drugs

1. To comply with regulations on good practice in clinical trials of drugs; to report on clinical trial process and results and make urgent reports in case of necessity to the Health Ministry.

2. To enter into contracts for clinical trials of drugs with organizations and/or individuals having drugs subject to clinical trial and with clinical trial participants.

Article 62.- Stages and procedures of clinical trials of drugs

1. Clinical trials of drugs must be conducted through various stages of and comply with regulations on good practice of clinical trial of drugs.

2. The Health Minister shall specify the conditions, dossiers, order and stages of clinical trial of drugs.