Circular No. 08/2010/TT-BYT dated April 26, 2010, of the Ministry of Health guiding report of bioavailability/bioequivalence study data when registering drugs
MINISTRY OF HEALTH
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
Hanoi, April 26, 2010
GUIDING REPORT OF BIOAVAILABILITY/BIOEQUIVALENCE STUDY DATA WHEN REGISTERING DRUGS
Pursuant to the Law on Pharmacy dated 14/6/2005;
Pursuant to the Decree No.188/2007/ND-CP dated 27/12/2007 of the Government stipulating the function, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Decree No.79/2006/ND-CP dated 9/8/2006 of the Government detailing the implementation of a number of Articles of the Pharmacy Law;
To participate in the integration process in ASEAN on drug registration, the Ministry of Health guidelines for the report of bioavailability/bioequivalence study data in drug registration as follows:
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Article 1. Scope of governing
This Circular guides the report of bioavailability/bioequivalence study data in drugs circulation registrationin Vietnam.
Article 2. Subjects of application
This Circular applies to domestic and foreign agencies, organizations, and individuals whose activities are related to the circulation registration of drugs in Vietnam.
Article 3. Interpretation of terms
1. Invention drug (Innovator pharmaceutical product) means the drug licensed for the first circulation, on the basis of full data on quality, safety, and efficiency.
2. Generic drug (generic product) means a finished drug in order to replace an invention drug produced without concession license of the invention company and marketed after the patent and the monopolies have expired their term.
3. Control drug (Comparator product) means drug that generic drug will be used to replace it in therapy. Normally, the control drug is an invention drug with data on effectiveness, safety, and quality which have been established.
4. Dosage equivalence (Pharmaceutical equivalence): the drugs are considered as dosage equivalence if they contain the same pharmaceutical substance with the same content in the same dosage form, same usage and reaching the same level of quality standards.
5. The made substitutes (Pharmaceutical alternatives): The drugs are considered as made substitutes if they contain the same type of pharmaceutical substance but different from chemical forms of the pharmaceutical substance (base, salt or ester ...) or different from content or dosage forms.
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6. Bioavailability means the characteristic indicates the speed and extent of absorption of a pharmaceutical substance or group of substances with effects on general circulation and is available in place of impact. It is also possible to understand that the bioavailability indicates the extent and speed of the pharmaceutical substance or substance that are released from the dosage form and is available in general circulation.
7. Bioequivalence (Bioequivalence): Two drugs are considered as bioequivalence if they are pharmaceutical equivalence drug or pharmaceutical alternatives, and their bioavailability after taking the same dose in the same conditions of test is similar so their treatment effect is considered to be basically equivalent to each other.
8. Conventional dosage forms: a dosage form using exipients and classical preparation technique, without intention to change the release speed of pharmaceutical substance out of dosage forms.
9. Modified release dosage forms (Modified release dosage form): means the dosage form to use some excipients and/or preparation techniques different from conventional dosage forms to create pharmaceutical substance release speed different from the form conventional dosage. It includes accelerated, rhythm, stretching, delayed release dosage form...
10. Extended-release dosage form (extended release, sustained release dosage form): means a form of modified release dosage with a speed of pharmaceutical substance release which is changed by the direction of the prolonged effects of the drug to reduce the frequency of use of drugs compared with conventional dosage forms of the same pharmaceutical substance.
11. Delayed release dosage forms (Delayed release dosage form): means a modified release dosage forms that pharmaceutical substance is delayed for a certain period of time after treatment and then released as normal in conventional dosage forms. Package dosage form dissolved in the intestine is of this type.
12. Approved drugs: Within the scope of this Circular, the drugs which have been approved means invention drug or generic drug with sufficient data of bioavailability/bioequivalence study meeting requirements and granted circulation registration numbers.
Article 4. Regulations for the study of bioavailability/bioequivalence
1. The study must be designed and implemented in accordance with provisions in the guideline to study bioavailability/bioequivalence of ASEAN or the equivalent guidance of the other organizations (such as the World Health organization (WHO) , international Conference on harmony (ICH), the U.S. Food Drug Administration (U.S. FDA)). For the studies conducted in Vietnam, before the study, research scheme must be evaluated and approved by specialized technical agencies authorized by the Ministry of Health.
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