Chương III Thông tư 22/2009/TT-BYT: Quy định cụ thể đối với hồ sơ đăng ký thuốc

Chapter III

SPECIFIC PROVISIONS ON DRUG REGISTRATION DOSSIERS

Section 1. REGISTRATION DOSSIERS FOR FINISHED PHARMACEUTICAL DRUGS, VACCINES, ANTIGEN-CONTAINING SERA AND BIOLOGICALS

Article 17. Dossiers to be submitted

1. First-time registration dossiers for new pharmaceutical drugs, vaccines, antigen-containing sera or biologicals, comprising:

a/ Part I. Administrative dossier and product information:

b/ Part II. Quality dossier:

c/ Part III. Pre-clinical dossier;

d/ Part IV. Clinical dossier.

2. First-time registration dossiers for generic drugs (applicable only to pharmaceutical drugs), comprising:

a/ Part I. Administrative dossier and product information;

b/ Part II. Quality dossier.

3. Re-registration dossiers, comprising:

a/ Part I. Administrative dossier and product information;

b/ Part II. Quality dossier;

c/ Part III. Circulation report (made according to a set form).

4. Dossiers of registration of major changes:

a/ Part I. Administrative dossier and product information;

b/ Part II. Quality dossier;

c/ Part III. Clinical dossier.

The details of major changes and relevant dossiers to be submitted are guided in Section I. Appendix II to this Circular (not printed herein).

5. Dossiers of registration of minor changes:

a/ Part I. Administrative dossier and product information;

b/ Part II. Quality dossier;

The details of minor changes and relevant dossiers to be submitted are guided in Section II, Appendix II to this Circular (not printed herein).

6. Dossiers of registration of other changes are guided in Section III, Appendix II to this Circular (not printed herein).

7. For the dossiers specified in Clauses 1 thru 6 of this Article:

a/ They must comply with the provisions in Appendix I to this Circular (not printed herein), including:

- ACTD;

- Guidance on stability research;

- Guidance on appraisal of the manufacturing process;

- Guidance on appraisal of analysis methods;

- Guidance on bioavailability and bioequivalence research;

b/ They must be made according to the ACTD's form. Dossiers of new pharmaceutical drugs, vaccines, antigen-containing sera and biologicals which cannot be made according to the ACTD's form may be made like common technical dossiers of the International Conference on Harmonization (ICH-CTD).

8. For processed drugs, requirements on dossiers to be submitted comply with the Health Ministry's current regulations on drug processing.

Article 18. Specific provisions on administrative dossiers and product information

An administrative dossier and product information comprise:

1. Cover, made according to a set form;

2. Table of contents;

3. Registration application, made according to a set form;

4. Authorization paper (if any), made according to a set form;

5. Operation license for drugs and drug materials, for foreign drug trading establishments in Vietnam, or drug trading eligibility certificates, for Vietnamese drug trading establishments;

6. CPR made according to a set form, for foreign drugs;

7. FSC, for foreign drug registration establishments possessing no CPPs;

8. GMP certificate of the domestic drug manufacturer or of the foreign drug manufacturer, if the drug registration establishment submits the FSC or CPP without certification of the satisfaction of GMP standards. In case more than one manufacturer is involved in the process of drug manufacture, the drug registration establishment shall submit GMP certificates of all the manufacturers involved in the process of manufacturing finished products;

9. Drug label;

10. Product information:

a/ Use instructions, for generic drugs:

b/ Summary on product properties, for new pharmaceutical drugs, vaccines, antigen-containing sera and biologicals, made according to a set form;

c/ Information for patients, for drugs requiring no prescription, made according to a set form.

11. Report on the circulation of drugs, for re-registration dossiers, made according to a set form;

12. Franchise agreement or contract, for drugs manufactured under franchise;

13. Certificates, protection titles and right transfer contracts, for related industrial property objects (if any):

14. Other legal papers (if any).

Article 19. Specific provisions on quality dossiers

A quality dossier is guided in Part II-ACTD and comprises:

1. Table of contents;

2. Summary on quality;

3. Contents and data;

4. Documents for reference;

5. The manufacturer's general dossiers, made according to a set form. In case a product is manufactured in more than one stage, the general dossiers must be dossiers of all the manufacturers involved in manufacturing the product before
putting it into the market.

Article 20. Specific provisions on pre-clinical dossiers

A pre-clinical dossier is guided in Part III-ACTD and comprises:

1. Table of contents;

2. General pre-clinical research;

3. Summary on pre-clinical research;

4. Report on pre-clinical research;

5. Documents for reference.

Article 21. Specific provisions on clinical dossiers

A clinical dossier is guided in Part IV-ACTD and comprises:

1. Table of contents;

2. Clinical overview;

3. Clinical summary;

4. List of clinical researches;

5. Report on clinical research;

6. Documents for reference.

Section II. DOSSIERS OF REGISTRATION OF IN-VITRO DIAGNOSIS BIOLOGICALS

Article 22. Dossiers to be submitted

1. First-time registration dossiers for diagnosis biologicals. including semi-finished products, comprising:

a/ Part I. Administrative dossier;

b/ Part II. Quality dossier;

c/ Part III. Dossier of diagnosis efficiency, not applicable to semi-finished products;

2. Re-registration dossiers, comprising:

a/ Part I. Administrative dossier;

b/ Part II. Quality dossier;

c/ Part III. Circulation report, made according to a set form.

3. Dossiers of registration of major changes comply with provisions applicable to first-time registration as guided in Appendix III B to this Circular (not printed herein).

4. Dossier of registration of minor changes, comprising:

a/ Registration application (made according to a set form);

b/ Change-related dossiers as specified in Appendix III A to this Circular (not printed herein).

Article 23. Specific provisions on administrative dossiers and product information

An administrative dossier comprises:

1. Cover, made according to a set form;

2. Table of contents;

3. Registration application, made according to a set form;

4. Product label;

5. Authorization paper (if any), made according to a set form;

6. Operation license in Vietnam for vaccines and biologicals, granted by a competent agency, if the registration establishment is a foreign enterprise; or certificate of eligibility for trading in vaccines and biologicals, if the registration establishment is a Vietnamese enterprise;

7. License for circulation of products in the country of origin, for foreign products (not applicable to semi-finished products);

8. GMP or ISO certificate or certificate of satisfaction of equivalent standards of manufacturers involved in the manufacturing process, granted by a competent agency;

9. Intellectual property certificate, economic contract and other papers (if any).

The dossier details are guided in Appendix III A to this Circular (not printed herein).

Article 24. Specific provisions on quality dossiers

A quality dossier comprises:

1. Table of contents;

2. Components of active ingredients;

3. Finished products;

4. Stability.

The dossier details are guided in Appendix III A to this Circular (not printed herein).

Article 25. Specific provisions on dossiers of effect evaluation of diagnosis biologicals

A dossier of effect evaluation of diagnosis biologicals comprises:

1. Table of contents;

2. Research reports.

3. The dossier details are guided in Appendix III A to this Circular (not printed herein).

Section III. DOSSIERS OF REGISTRATION OF DRUGS FROM MEDICINAL MATERIALS, ORIENTAL MEDICAMENTS AND DRUG MATERIALS

Article 26. Dossiers to be submitted

1. First-time registration dossiers, comprising:

a/ Administrative dossier and product information;

b/ Quality dossier;

c/ Safety and effect dossier, applicable only to new drugs and new drug materials.

2. Re-registration dossiers, comprising:

a/ Administrative dossier and product information;

b/ Quality dossier;

c/ Circulation report, made according to a set form.

3. Dossiers of registration of major changes: Details of major changes and dossiers to be submitted are guided in Section I. Appendix II to this Circular (not printed herein).

4. Dossiers of registration of minor changes: Details of minor changes and dossiers to be submitted are guided in Section II, Appendix II to this Circular (not printed herein).

5. Dossiers of registration of other changes, which are guided in Section III. Appendix II to this Circular (not printed herein).

Article 27. Specific provisions on administrative dossiers and product information

Administrative dossiers and product information are specified in Article 18 of this Circular.

Article 28. Specific provisions on quality dossiers

1. Manufacturing process a/ Materials:

- For drugs from medicinal materials and oriental medicaments: The manufacturing process is not required for excipient and materials named in the pharmacopoeia and materials manufactured by other manufacturers. In other cases, the process of manufacturing materials must be described in full and detail.

- For drug materials: The process of manufacturing materials must be described in full and detail.

b/ Finished products:

- Formula for the smallest unit of packing: names of materials, including main components and excipient; content or concentration of each material; materials' applicable standards. If finished products are manufactured from bone glue, the quantity of medicinal materials must be indicated;

- Formula for a lot or batch of manufacture: names of materials, including main components and excipient; weight or volume of each material;

- Diagram of the manufacturing process, including all stages;

- Description of the manufacturing process: to describe in full and detail each stage in the manufacturing process;

- List of equipment and instruments used: names of equipment, specifications and use purposes;

- Control in the manufacturing process: to describe in full and detail the criteria for inspection and control in the manufacturing process.

2. Quality standards and testing methods

a/ For drug materials named in the pharmacopoeia, to indicate the name of the pharmacopoeia and year of publication. For those not named in the pharmacopoeia, to describe in full and detail the testing criteria and methods.

b/ Finished products:

- Formula for the smallest unit of packing: names of materials, including main components and excipient; content or concentration of each material; materials' applicable standards. If finished products are manufactured from bone glue, the quantity of medicinal materials must be indicated;

- Finished-product standards: to describe in full and detail the finished products' testing criteria and methods.

c/ Packing standards: to describe in full and details the testing criteria and methods.

d/ Drug test slips are specified in Article 7 of this Circular.

e/ Stability research documents, comprising:

- Stability research plan;

- Stability research data;

- Stability research conclusions.

Article 29. Specific provisions on safety and effect dossiers

Safety and effect dossiers of new drugs comply with the Health Ministry's regulations on clinical testing, comprising:

1. Reports on toxicity;

2. Reports on clinical research, not applicable to cases of registration of materials.