Chương II Thông tư 03/2012/TT-BYT: Các thuốc phải thử lâm sàng, miễn thử lâm sàng và miễn một số giai đoạn thử lâm sàng

Chapter II

DRUGS OF CLINICAL TRIAL, EXEMPTED FROM CLINICAL TRIAL AND EXEMPTED FROM SOME STAGES OF CLINICAL TRIAL

Article 5. Drugs of clinical trial of complete stages

1. For pharmaceutical drugs, medical biological products:

a) Pharmaceutical drugs containing new substance, drugs with new combination of drugs circulated.

b) Medical biological products first invented or with new combination of components that have been circulated.

c) Pharmaceutical drugs, foreign medical biological products which have been circulated legally but not enough 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow).

d) Pharmaceutical drugs, medical biological products which have been conducted clinical trials before the effective date of this Circular but not yet met the provisions of good clinical practice of the Ministry of Health or the international guidelines on good clinical practice accredited by the Health Ministry.

2. For vaccines:

a) Vaccine newly-researched, produced, and firstly used.

b) Foreign vaccine which have been circulated legally but not enough 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow).

c) Vaccine that has been conducted clinical trial before the effective date of this Circular but not yet met the provisions of good clinical practice of the Ministry of Health or the international guidelines on good clinical practice accredited by the Health Ministry.

3. For traditional medicines or drugs from medicinal plants:

a) Drugs containing new pharmaceuticals firstly used in humans.

b) Drugs that have been conducted clinical trial before the effective date of this Circular but not yet met the provisions of good clinical practice of the Ministry of Health or the international guidelines on good clinical practice accredited by the Health Ministry.

Article 6. Drugs exempted from clinical trial

1. For pharmaceutical drugs, medical biological products:

a) Pharmaceutical drugs called original name (generic drugs).

b) Foreign drugs that have not been issued registration numbers for circulation in Vietnam but have been circulated legally for at least 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow) and have been certified by competent state agencies as safe and effective, with the same use, and content and indicated in Vietnam as specified in that country.

c) Foreign drugs that have been issued registration numbers for circulation in Vietnam, but there are changes or supplements of new indications, new use, new dosage forms as same as those drugs which have been circulated legally for at least 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow).

2. For vaccines:

a) Foreign vaccines that have been issued valid registration numbers for circulation in Vietnam, are imported into Vietnam to complete the stage of labeling, putting in the box.

b) Re-registered vaccines in Vietnam due to expiration of the registration numbers and without any changes.

3. For traditional medicines or drugs from medicinal plants:

a) The herbal remedies accredited by the Health Ministry.

b) Traditional medicines or drugs from foreign material herbs which have not been granted registration numbers for circulation in Vietnam but have been circulated legally for at least 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow) and have been certified by competent state agencies of that country as safe and effective, with the same use, and content and indicated in Vietnam as specified in that country.

Article 7. Drugs exempted from some clinical trial stages

1. For pharmaceutical drugs, medical biological products:

Foreign drugs that have been issued registration numbers for circulation in Vietnam, but there are changes or supplements of new indications, new use, new dosage forms other than indications, use, dosage forms of the drugs which have been circulated legally for at least 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow) must be:

a) Conducted clinical trial to assess the safety;

b) Conducted clinical trial to assess efficacy in case of not yet conducted that trial or completion of clinical trial but not yet met the provisions of good clinical practice of the Ministry of Health or the international guidelines on good clinical practice accredited by the Health Ministry.

2. For vaccines:

a) Clinical trial to assess safety for:

- Foreign vaccines that have not been issued registration numbers for circulation in Vietnam but have been circulated legally for at least 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow) and have been certified by competent state agencies as safe and effective, with the same use, and content and indicated in Vietnam as specified in that country.

- Vaccines produced in Vietnam and made from products awaiting for import packaging from abroad that their finished products have been circulated legally for at least 05 years in the country of origin (or reference country if the international treaties to which Vietnam is a member allow).

- Vaccines which have been granted registration numbers for circulation in Vietnam, but there are changes or supplements of excipients, preservatives, change of production facilities (not changing the production process).

b) Clinical trial to assess the safety and immunogenicity in stage 3 for:

- Foreign vaccines which have been circulated legally for at least 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow) transferred production technology in Vietnam.

- Vaccines produced in Vietnam made from imported intermediate products that their finished products have been circulated legally for at least 05 years in the country of origin (or reference country if the international treaties to which Vietnam is a member allow).

- Vaccines which have been granted registration numbers for circulation in Vietnam, but there are changes or addition of the contents such as: production processes, dosage forms, indications, using subjects (age, gender, nation), use, dosage, vaccination schedule.

3. For medicines or drugs from medicinal herbs:

Clinical trial to assess the safety of drugs which have been granted registration numbers for circulation in Vietnam and other herbal remedies accredited by the Health Ministry but there are changes or supplements of indication, use, dosage forms other than indication, use, dosage forms of the drugs which have been circulated legally for at least 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow).

Article 8. Clinical drug trial in some special cases, emergency related to health security

Minister of Health considers and makes decision to exempt certain stages of clinical drug trial on the basis of advice of the Advisory Council for Granting Drug Circuation registration numbers and the Council of Ethics in biomedical research - Ministry of Health for the following cases:

1. Drugs used in special cases, emergency related to health security include:

a) Pharmaceutical drugs, medical biological products, vaccines which have been circulated legally but not enough 05 years in the country of origin (or reference country if international treaties to which Vietnam is a member allow), which clinical trial data of multi-centers conducted in Vietnam and Asia has, the research results proved to achieve safety and effectiveness, with the same content, indication and use in Vietnam as indicated in that country.

b) Pharmaceutical drugs, traditional medicines or drugs from medicinal herbs meeting the requirements for special treatment on the list of rare drugs issued by the Health Ministry, with special dosage forms which have not been produced domestically, have no any alternative medicine and if this kind of drugs are not used, will affect the life of the patients, have not been granted registration numbers for circulation in Vietnam but has been circulated legally but not enough 05 years in the country of origin (or the reference country if international treaties to which Vietnam is a member allow) and have been certified by competent state agencies to be safe and effective, with the same use, and content and indicated in Vietnam as specified in that country.

c) Vaccines used to prevent dangerous infections newly arisen and unknown its pathogen or infectious diseases especially dangerous, capable of rapid spread, wide spread and high mortality, have not been granted registration numbers for circulation in Vietnam, have been circulated legally but not enough 05 years in the country of origin (or the reference country if international treaties to which Vietnam is a member allow) and have been certified by competent state agencies to be safe and effective, with the same use, and content and indicated in Vietnam as specified in that country.

2. The drugs which have resulted from research projects, research theme of ministerial level or similar and above and are made before the effective date of this Circular and complied with the provisions of this Circular and the directions on good clinical practice, to be accepted and assessed satisfactory by the council of science and technology of equivalent or ministerial-level and recommended for wide application.