Regulations on Drug and Drug Ingredient Registration and Circulation in Vietnam

Regulations on Drug and Drug Ingredient Registration and Circulation in Vietnam

1. Significance of Drug Registration Number

The drug registration number is a crucial factor in ensuring efficacy and safety for users. It helps distinguish drugs from functional foods and cosmetics, guaranteeing the quality and origin of the drug are strictly controlled.

2. Types of Changes in Registration Files

• Major Changes: Changes that significantly impact the quality, safety, and efficacy of the drug directly.

• Minor Changes: Changes that have no or minimal impact on the efficacy, quality, and safety of the drug.

3. Definition of Drug

A drug is a preparation containing pharmaceutical substances or materials used for human purposes with the aim of:

• Disease prevention

• Disease diagnosis

• Disease treatment

• Disease management

• Alleviating symptoms

• Adjusting human physiological functions

4. Drug Classification:

• Pharmaceutical Drugs: Drugs containing pharmaceutical substances with defined composition, formula, purity, and meet drug standards. This includes injectable drugs extracted from medicinal herbs, and drugs combining pharmaceutical substances with medicinal herbs, proven for safety and efficacy.

• Herbal Medicines: Drugs composed of medicinal herbs and have effects supported by scientific evidence, excluding traditional medicines.

• Vaccines: Drugs containing antigens that induce immune response in the body, used for disease prevention and treatment.

• Biological Products: Drugs produced using biotechnology or biological processes from biological substances or mixtures of high-molecular-weight substances, including derivatives of human blood and plasma.

5. Drug Types by Origin:

• Original Brand-Name Drug: The first drug to be licensed for circulation, based on complete data on quality, safety, and efficacy.

• New Drug: A drug containing a new pharmaceutical substance, new combination, or medicinal herb used for the first time in Vietnam.

6. Subjects and Forms of Drug Registration:

• Initial Drug Registration: Registration for drugs without a circulation license.

• Re-registration: Registration for drugs whose licenses have expired.

• Renewal Registration: Renewal of the validity of the circulation license for drugs that have been licensed.

7. Duration for Granting Drug Circulation License:

• Imported drugs without a circulation license: Maximum 12 months.

• Imported drugs without a circulation license, with additional document requirements: Maximum 36 months.

• Renewal registration for drugs, drug ingredients: 3 months.

• Renewal registration for drugs, drug ingredients, with additional documents: 12 months.

• Changes and additions to the drug circulation license, drug ingredients (still valid): 3 months.

• Changes and additions to the drug circulation license, drug ingredients (minor changes): 15 days.

8. Validity of Drug Circulation License:

• Normal: 5 years.

• New drugs, vaccines, reference biological products, similar biological products: 3 years.

• Drugs with the same pharmaceutical substance, concentration, content, dosage form, administration, dosage, indications, patient group as the new drug (not yet licensed for 5 years): 3 years.

• Drugs without safety and efficacy reports: 3 years.

• Drugs with safety and efficacy reports but with limited usage, patients, and duration: 3 years.

• Drugs for continued safety and efficacy monitoring: 3 years.

9. Regulations on the Withdrawal of Circulation License:

• Decision on Withdrawal: Drug Administration Department.

• Notification of Withdrawal: Department of Health.

10. Common Technical Files:

• ASEAN ACTD: Drug registration files meeting the common technical requirements of the Association of Southeast Asian Nations.

• ICH CTD: Common file template of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

11. Referenced Regulatory Agencies:

• Europe: European Medicines Agency (EMA).

• USA: Food and Drug Administration (FDA).

• Japan, France, Germany, Sweden, UK, Switzerland, Australia, Canada, Belgium, Austria, Ireland, Denmark, Netherlands.

12. Certificate of Pharmaceutical Product (CPP):

Certificate issued according to the quality certification system for pharmaceutical products circulating in international trade by the World Health Organization (WHO).

13. Clinical Data Requirements:

• New pharmaceutical drugs: Clinical data is required to ensure safety and efficacy.

• Vaccines, biological products: Clinical data is required to ensure safety and efficacy.

• Drugs with new combinations of pharmaceutical substances: Clinical data is required to ensure safety and efficacy.

• Similar biological products: Clinical data is required to ensure safety and efficacy.

• New pharmaceutical drugs that are not original brand-name drugs: Clinical data is required to ensure safety and efficacy.

• Pharmaceutical drugs with different content, concentration, route of administration, administration method, dosage, indications, patient group compared to the original brand-name drug: Clinical data is required to ensure safety and efficacy.

• Drugs already licensed in Vietnam but have changes and additions related to clinical data: Clinical data is required to ensure safety and efficacy.

• New herbal medicines: Clinical data is required to ensure safety and efficacy.

14. Criteria for Exemptions from Some Clinical Trial Phases:

• New pharmaceutical drugs, vaccines, biological products:

• Urgent need, no alternative drugs.

• Licensed by at least two of the referenced regulatory agencies or licensed in the USA (FDA) or by EMA based on clinical files exempt according to regulations of these agencies.

• Treatment for rare diseases, serious diseases.

• Vaccines, biological products manufactured in Vietnam through technology transfer of some or all stages of the manufacturing process, where the vaccines, biological products before technology transfer have clinical data meeting regulations.

• Herbal medicines:

• Urgent need, no alternative drugs.

• Licensed by at least two of the referenced regulatory agencies (based on clinical files exempt according to regulations of these agencies).

• Herbal medicines with new combinations of medicinal herbs previously used as drugs in Vietnam and with indications for diseases on the list issued by the Minister of Health.

• Drugs with new combinations of medicinal herbs previously used as drugs in Vietnam and with no indications for diseases on the list of diseases issued by the Minister of Health.

• Generic drugs:

• Drugs with the same pharmaceutical substance, concentration, content, route of administration, administration method, dosage, indications, patient group, dosage form as another drug that has been licensed for circulation.

• New drugs (excluding vaccines) licensed in at least one country worldwide and with complete clinical data on safety and efficacy.

15. Phase 4 Clinical Trial Requirements:

Drugs that have been granted a circulation license but need further assessment of safety and efficacy based on the advice of the advisory board for granting drug circulation license, drug ingredients.