REQUIREMENTS OF NEW PHARMA REGISTRATION DOSSIER IN VIETNAM
According to Circular 32/TT-BYT dated Nov. 12, 2018
No | REQUIREMENTS | GENERIC | Instruction for signing and stamp | Who will sign/stamp (Notes: In case having form 8B/TT, Chief of rep office in VN can sign on all reg. documents. Stamp of rep office will be used to replace for stamp of applicant. In case the authorized person signs on the application who is not the chief representative of office in Vietnam, the authorization letter Form 8B must be sealed and signed by the chief representative office in Vietnam.) | |
PART 1: ADMINISTRATIVE DOSSIER AND INFORMATION OF PRODUCTS | 1 original copy & 02 copies of application form 6/TT | ||||
1 | Cover page (Form 3/TT) | 1 copy | No required | ||
2 | Brief of product – Form 4/TT | 1 copy | Stamp at right corner at the top of page. | Applicant will stamp | |
3 | List of content (Form 5/TT) | 1 copy | |||
4 | Application for registration – Form 6/TT | 1 original copy of each | Sign and stamp | Director of applicant will sign and put the stamp of applicant | |
5 | Letter of Authorization – Form 08/TT * Form 8A/TT: Authorization for applicant * Form 8B/TT: Authorization for signing on registration dossier (only required if director of applicant wants to authorize for Chief of rep office in Vietnam to sign reg. dossier) (In case the authorized person signs on the application who is not the chief representative of the office, the authorization letter must be signed and sealed by the chief representative office in Vietnam) | – 1 original/notarized copy with legalization at Vietnam embassy – 1original/ copy with applicant’s RO stamp | Sign and stamp | – 8A: The product license holder (mentioned in CPP) sign and stamp and legalize by Vietnamese Embassy – 8B: Director of applicant and Chief of rep office in Vietnam will sign and stamp | |
6 | – Vietnam company: Certificate for satisfying business condition in medicine: (at least one of 04 scopes: manufacture, wholesale, export, import) – Foreign company: + Pharmaceutical Business License (at least one of 04 scopes: manufacture, wholesale, export, import) + License of Rep. office in Vietnam | – 01 copy with applicant stamp + 01 original/notarized copy with legalization at Vietnam embassy | – Certificate for satisfying business condition in medicine: applicant will stamp: Put stamp at right corner at the top of first page and put a boundary stamp on all pages (Applicant is Vietnam company) | ||
7 | CPP according to WHO-format In case CPP doesn’t mention that Manufacturer meets GMP-WHO, GMP-WHO certificate is required. If there are many manufacturers take part in the manufacturing process of finished product, GMP-WHO certificates of all manufacturers are required. CPP need to have: from 01/01/2022 with information: – Drug formulation: It is required to fully state the composition, concentration/content of each pharmaceutical substance, excipients. For soft capsules, hard capsules must have more information about the composition of the capsule shell. – Specification DP, DS, DS manufacturer’s name and address – All manufacturers and role of each – Attachments need to certify by authority to issue CPP – In case the drug is not licensed for marketing in the manufacturing country or is licensed but not is actually marketed in the manufacturing country: provide another CPP certifying that the drug is licensed for marketing and is marketed in one of the member of Strignet regulatory authorities | 1 original/notarized copy with legalization at Vietnam embassy | No required | ||
8 | Drug label intended circulation in Vietnam – Original set of designed label (under guideline of Circular 01/2018/TT-BYT) | 3 sets of original copies | Put stamp on a part of label (box, blister/bottle label,…) | Applicant will stamp | |
9 | Product information (in Vietnamese or in both Vietnamese and English) – Package insert | 3 original copies | PI: Put stamp at right corner at the top of first page and put a boundary stamp on all pages | Applicant will stamp | |
10 | Drug label and package insert circulate in manufacturer’s country or country issue CPP If PI is not in English, need translate to Vietnamese | 1 original copy | Put stamp on a part of label (box, blister/bottle label,…) PI: Put stamp at right corner at the top of first page and put a boundary stamp on all pages | Applicant will stamp | |
11 | Summary of product characteristics – Form 9/TT (in Vietnamese) | 1 original copy | Put stamp at right corner at the top of first page and put a boundary stamp on all pages | Applicant will stamp | |
12 | Legal documents of manufacturer of drug substance, excipients, capsule shell, herbal pharmaceutical materials, semi-finished herbal pharmaceutical materials justify adapt with GMP (one of below): from 01 Sep 2019: required for drug substance from 01 Jan 2021: required for excipients, capsule shell, herbal pharmaceutical materials, semi-finished herbal pharmaceutical materials. – GMP certificate – Manufacturing license that justify GMP – CPP for DS mention GMP – CEP | 1 original/notarized copy with legalization at Vietnam embassy | NA | NA | |
13 | Protection certificates, contracts on transfer of industrial property rights, documents certifying the origin of materials (GACP, CEP, domestic herbal sources, imported herbal sources, …) and other relevant documents (If any). For legal document in electronic version: link to website of issued authority (English website) + Commitment of applicant is responsible for the legality of this document. | + 1 copy with legalized by Vietnamese Embassy (for legal document issued by Competent Authority), and 01 notarized copy for others | No required | ||
PART 2: QUALITY DOSSIER | 1 original copy + 2 copies of Specification of finished product + Method of analysis (P5.1+P5.2) | ||||
A | Table of Content | √ | |||
B | Quality Overall Summary | √ | Stamp on the first page which contains information (the first page is not devided page which only contains the sentense “Quality Overall Summary”) | Applicant will stamp | |
S. DRUG SUBSTANCE | |||||
S.1. General Information | |||||
1.1. Nomenclature | √ | ||||
1.2. Structure | √ | ||||
1.3. General Properties | √ | ||||
S.2. Manufacture | |||||
2.1. Manufacturer (s) | √ | ||||
2.2. Description of Manufacturing Process and Process Controls | |||||
2.3 Control of materials | |||||
2.4. Control of Critical Steps and Immediates | |||||
2.5. Process Validation and/or Evaluation | |||||
2.6. Manufacturing Process Development | |||||
S.3. Characterization | |||||
3.1. Elucidation of Structure and other characteristics | √ | ||||
3.2. Impurities | √ | ||||
S.4. Control of Drug Substance | |||||
4.1. Specification | √ | ||||
4.2. Analytical Procedures | √ | ||||
4.3. Validation of Analytical Procedures | √ | ||||
4.4. Batch Analysis | |||||
4.5. Justification of Specifications | |||||
S.5. Reference Standards or Materials | √ | ||||
S.6. Container Closure System | |||||
S.7. Stability | √ | ||||
P. DRUG PRODUCT | |||||
P.1. Description and Composition: – Formula for smallest unit – Description of packing material and packaging materials | √ | ||||
P.2. Pharmaceutical Development | |||||
2.1. Information on Development Studies | |||||
2.2. Components of the Drug Product | √ | ||||
2.3. Finished Product | √ | ||||
2.4. Manufacturing Process Development | |||||
2.5. Container Closure System | √ | ||||
2.6. Microbiological Antributes | √ | ||||
2.7. Compatibility | √ | ||||
P.3. Manufacture | |||||
3.1. Batch Formula | √ | ||||
3.2. Manufacturing Process and Process Control Flow Chart of Manufacturing and Packaging Process List of Equipment used in Manufacturing and Packaging Process | √ | ||||
3.3. Control of Critical Steps and Intermediates | √ | ||||
3.4. Process Validation and/or Evaluation | √ | ||||
P.4. Control of excipients | |||||
4.1. Specification | √ | ||||
4.2. Analytical Procedures | √ | ||||
4.3. Excipient of Human or Animal Origin | √ | ||||
4.4. Novel excipients | |||||
P.5. Control of Finished Product | |||||
5.1. Specification | √ | Sign and stamp by DP manufacturer | |||
5.2. Analytical procedures | √ | Sign and stamp by DP manufacturer | |||
5.3. Validation of Analytical Procedures | √ | ||||
5.4. Batch Analysis | |||||
5.5. Characterisation of Impurities | √ | ||||
5.6. Justification of Specifications | √ | ||||
P.6. Reference Standards or Materials | √ | ||||
P.7. Container Closure System | √ | ||||
P.8. Stability | √ | ||||
P.9. Product Interchangeability Equivalence evidence | √ (follow the requirements according to Circular 08/2010/TT-BYT dated Apr. 26, 2010) | ||||
C | Body of Data | ||||
S. DRUG SUBSTANCE | |||||
S.1. General Information | Stamp on the first page which contains information | Applicant will stamp | |||
1.1. Nomenclature | √ | ||||
1.2. Structure | √ | ||||
1.3. General Properties | √ | ||||
S.2. Manufacture | |||||
2.1. Manufacturer (s) | √ | ||||
2.2. Description of Manufacturing Process and Process Controls | |||||
2.3 Control of materials | |||||
2.4. Control of Critical Steps and Immediates | |||||
2.5. Process Validation and/or Evaluation | |||||
2.6. Manufacturing Process Development | |||||
S.3. Characterization | |||||
3.1. Elucidation of Structure and other characteristics | √ | ||||
3.2. Impurities | √ | ||||
S.4. Control of Drug Substance | |||||
4.1. Specification | √ | Stamp and sign | Manufacturer will sign and stamp, original | ||
4.2. Analytical Procedures | √ | Stamp and sign | Manufacturer will sign and stamp, original | ||
4.3. Validation of Analytical Procedures | √ | ||||
4.4. Batch Analysis | |||||
4.5. Justification of Specifications | |||||
S.5. Reference Standards or Materials | √ | ||||
S.6. Container Closure System: | |||||
S.7. Stability: – Long term condition – Accelerate condition | √ | Stamp and sign | Manufacturer of DS will sign and stamp, original (accept photocopy from original with stamp by applicant) | ||
P. DRUG PRODUCT | |||||
P.1. Description and Composition: – Formula for smallest unit: name and quantity of all active and inactive ingredients – Description of packing material and packaging materials | √ | Stamp on the first page which contains information | Applicant will stamp | ||
P.2. Pharmaceutical Development | |||||
2.1. Information on Development Studies | |||||
2.2. Components of the Drug Product | √ | ||||
2.3. Finished Product | √ | ||||
2.4. Manufacturing Process Development | |||||
2.5. Container Closure System | √ | ||||
2.6. Microbiological Antributes | √ | ||||
2.7. Compatibility | √ | ||||
P.3. Manufacture | |||||
3.1. Batch Formula | √ | ||||
List of Equipment used in Manufacturing and Packaging Process | √ | ||||
3.2. Manufacturing Process and Process Control | √ | ||||
Flow Chart of Manufacturing and Packaging Process | √ | ||||
3.3. Control of Critical Steps and Intermediates | √ | ||||
3.4. Process Validation and/or Evaluation | √ | ||||
P.4. Control of excipients | |||||
4.1. Specification | √ | ||||
4.2. Analytical Procedures | √ | ||||
4.3. Excipient of Human or Animal Origin | √ | ||||
4.4. Novel excipients | |||||
P.5. Control of Finished Product | |||||
5.1. Specification | √ | Stamp and sign | Manufacturer will sign and stamp, original (accept photocopy from original with stamp by applicant) | ||
5.2. Analytical procedures | √ | Stamp and sign | Manufacturer will sign and stamp, original (accept photocopy from original with stamp by applicant) | ||
5.3. Validation of Analytical Procedures | √ | ||||
5.4. Batch Analysis Summary of protocol of 3 consecutive lots | |||||
5.5. Characterisation of Impurities | √ | ||||
5.6. Justification of Specifications | √ | ||||
P.6. Reference Standards or Materials | √ | ||||
P.7. Container Closure System | √ | ||||
P.8. Stability – Long term condition at Zone 4B – Accelerate condition | √ | Stamp and sign | Manufacturer will sign and stamp, original (accept photocopy from original with stamp by applicant) | ||
P.9. Product Interchangeability Equivalence evidence | √ (follow the requirements according to Circular 08/2010/TT-BYT dated Apr. 26, 2010) (including 01 set of Brief product form 4/TT) | ||||
D | Certificate of analysis issued by manufacturer – for finished product – for drug substance – for excipient which has non- compendial specification – Batch release certificate of 3 consecutive lots with legalization | √ √ √ – | COA for drug substance and excipient: signature and stamp of manufacturer | Manufacturer will sign and stamp, original | |
Certificate of analysis for finished product issued by National Institute for Control of Vaccine and Biological in Vietnam (NICVB) | – | ||||
E | Reference documents | Stamp on the first page which contains information | Applicant will stamp | ||
PART 3: PRE-CLINICAL DOSSIER | NA | Stamp on the first page | Applicant will stamp | ||
Brief of product – Form 4/TT | Stamp on the first page | Applicant will stamp | |||
A | Table of Content | ||||
B | Nonclinical Over View | ||||
1. General Aspect | |||||
2. Content and Structural Format | |||||
C | Nonclinical Summary (Written and Tabulated) | ||||
1. Nonclinical Written Summaries | |||||
Introduction | |||||
General Presentation Issues | |||||
2. Content of nonclinical written Summaries | |||||
2.1. Pharmacology | |||||
Primary Pharmacodynamics | |||||
Secondary Pharmacodynamics | |||||
Safety Pharmacology | |||||
Pharmacodynamics Drug Interactions | |||||
2.2. Pharmacokinetics | |||||
Absorption | |||||
Distribution | |||||
Metabolism | |||||
Excretion | |||||
Pharmacokinetics Drug Interaction (non-clinical) | |||||
2.3. Toxicology | |||||
Single Dose Toxicity | |||||
Repeat Dose Toxicity | |||||
Genotoxicity | |||||
Carcinogenicity | |||||
Reproductive and Developmental Toxicity | |||||
– Fertility and Early Embryonic Development | |||||
– Embryo-fetal Development | |||||
– Prenatal and Postnatal Development | |||||
Local Tolerance | |||||
Other Toxicity Studies (if available) | |||||
3. Content of Nonclinical Tabulated Summaries (Pharmacology, pharmacokinetics, toxicology) | |||||
D | Nonclinical Study Report (As requested) | ||||
1. Table of Content | |||||
2. Pharmacology | |||||
Primary Pharmacodynamics | |||||
Secondary Pharmacodynamics | |||||
Safety Pharmacology | |||||
Pharmacodynamics Drug Interactions | |||||
3. Pharmacokinetics | |||||
Analytical Methods and Validation Reports | |||||
Absorption | |||||
Distribution | |||||
Metabolism | |||||
Excretion | |||||
Pharmacokinetics Drug Interaction (non-clinical) | |||||
Other Pharmacokinetics Studies | |||||
4. Toxicology | |||||
Single Dose Toxicity | |||||
Repeat Dose Toxicity | |||||
Genotoxicity | |||||
– In vitro Report | |||||
– In vivo Report | |||||
Carcinogenicity | |||||
– Long Term Studies | |||||
– Short or Medium Term Studies | |||||
– Other Studies | |||||
Reproductive and developmental toxicity | |||||
– Fertility and early embryonic development | |||||
– Embryo-fetal development | |||||
– Prenatal and Postnatal development | |||||
– Studies in which the offspring are dosed and/or further evaluated | |||||
Local tolerance | |||||
Other Toxicity Studies, if available | |||||
– Antigenicity | |||||
– Immunotoxicity | |||||
– Dependence | |||||
– Metabolites | |||||
– Impurities | |||||
– Other | |||||
E | List of key Literature References | ||||
PART 4: CLINICAL DOSSIER | NA | Stamp on the first page | Applicant will stamp | ||
A | Table of contents | ||||
B | Clinical Overview | ||||
Product Development Rationale | |||||
Overview of Biopharmaceutics | |||||
Overview of Clinical pharmacology | |||||
Overview of Efficacy | |||||
Overview of Safety | |||||
Benefits and Risks Conclusion | |||||
C | Clinical Summary | ||||
Summary of Biophamaceutic Studies and Associated analytical Methods | |||||
Summary of Clinical phamacology studies | |||||
Summary of Clinical Efficacy | |||||
Summary of Clinical Safety | |||||
Synopses of individual study | |||||
D | Tabular Listing of All Clinical Studies | ||||
E | Clinical Study Reports | ||||
Report of Biopharmaceutic Studies | |||||
Repoort of Studies Pertinent to Pharmacokinetics Using Human Biomaterials | |||||
Report of Human Pharmcokinetic (PK) Studies | |||||
Report of Human Ppharmcodinamic (PD) Studies | |||||
Report of Efficacy and Safety Studies | |||||
Report of Post-Marketing Experience | |||||
Case Report Forms and Individual Patient Listings | |||||
F | List of Key Literature References | ||||
PART 5: GMP ASSESSMENT DOSSIER Applicable object: – Foreign manufacturer for the first time who having drugs registered for circulation in Vietnam; – Drug manufacturing line has not yet been evaluated by the Ministry of Health; – Drug raw materials are pharmaceutical substances registered for the first time in Vietnam; – Foreign manufacturer for the first time who having herbal materials registered for circulation in Vietnam. ‘- In case that the manufacturer belongs ICH, Australia and is inspected by one of following HA: FDA (USA)/ EMA (Euro)/ TGA (Australia)/ PMDA (Japan)/ Health Canada (Canada): required 1 & 2 – Other cases: required all (1-> 5) | 1 original copy | Stamp on the first page | Applicant will stamp | ||
Brief of product – Form 4/TT | 1 copy | Stamp on the first page | Applicant will stamp | ||
1 | GMP certificate / or GMP inspection report / or Manufacturing license | √ | 1 original/notarized copy with legalization at Vietnam embassy | ||
2 | Site master file conforming to the guidelines of European Union (EU) or the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) or the World Health Organization (WHO). | √ | 1 copy with manufacturer’s stamp | Manufacturer will stamp | |
3 | List of GMP inspections for last 3 years | √ | 1 copy with manufacturer’s stamp | Manufacturer will stamp | |
4 | Last GMP inspection report which has as inspection scope the registered drugs or dosage forms of the registered drugs | √ | 1 original/notarized copy with legalization at Vietnam embassy | ||
5 | Periodic quality review report for sterile drug product | √ | 1 copy with manufacturer’s stamp | Manufacturer will stamp | |
Note: 1. For ASEAN member countries, the studies report of part 3, part 4 may not be required for NCE, BIOTECH, and other MaV. if the Original Products are already registered and approved for market authorisation in Reference Countries. Therefore, submission of Study reports will be required upon request from Authority. 2. Symbol: √ :Necessary ∗ Where applicable, i.e change of route of administration due to change on formulation 3. Dossier should be presented in A4, with letter font as Times New Roman, size 12. 4. Enclosed forms |