REQUIREMENTS OF NEW PHARMA REGISTRATION DOSSIER IN VIETNAM

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REQUIREMENTS OF NEW PHARMA REGISTRATION DOSSIER IN VIETNAM

For generic drugs, the drug manufacturers need to prepare the drug dossier in according to ACTD form which includes administrative part and quality part. For your reference, KENFOX provide checklist for new drug registration with highlighted Generic column.

Notes:

symbol “√” means “required to provide”
symbol “X” means “not required to provide”

No.	Requirements	Quantity	Generic
PART 1: ADMINISTRATIVE DOSSIER AND INFORMATION OF PRODUCTS
1	Cover page (Form 1/TT)	1 copy	√
2	List of content	1 copy	√
3	Application for registration (Form 6A)	2 original copies	√
4	Letter of Authorization – Form 5/TT (if any)	2 original copies	√
5	Representative Office License in Vietnam	1 notarized copy	√
6	The manufacturing license in the origin country	1 notarized legalization copy	X
7	CPP according to WHO-format	1 notarized legalization copy	√
8	Drug label:- Original set of designed label- Original label that is being circulated in the country of origin	5 original sets2 original sets	√√
9	Product information (in Vietnamese) – Summary of product characteristics – Form2/ACTD (for new pharmaco-chemical drugs) – Package insert	2 original copies 6 original copies	√√
10	Under-license or processing agreement or contract regarding drugs manufactured under-license (if any)	1 copy	√
11	Certificates of trademark (acceptance letter of trademark), protection licence, contract of transfering industrial property right (if any)	1 notarized copy	√
12	Other legal documents (if any)	1 copy	√
13	Brief information of product (Form 4B)	1 copy	√
14	Overall information of the manufacturer	1 original copy	√
PART 2: QUALITY DOSSIER
A	Table of Content		√
B	Quality Overall Summary		√
	S. DRUG SUBSTANCE
	S.1. General Information		√
	S.2. Manufacture		√
	S.3. Characterization		√
	S.4. Control of Drug Substance		√
	S.5. Reference Standards or Materials		√
	S.6. Container Closure System		√
	S.7. Stability		√
	P. DRUG PRODUCT
	P.1. Description and Composition		√
	P.2. Pharmaceutical Development		√
	P.3. Manufacture		√
	P.4. Control of excipients		√
	P.5. Control of Finished Product		√
	P.6. Reference Standards or Materials		√
	P.7. Container Closure System		√
	P.8. Stability		√
	P.9. Product Interchangeability Equivalence evidence		(comply requirements under Circular 08/2010/TT-BYT)
C	Body of Data
	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 andProcess Controls		X
	2.3 Control of materials		X
	2.4. Control of Critical Steps and Immediates		X
	2.5. Process Validation and/or Evaluation		X
	2.6. Manufacturing Process Development		X
	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		X
	4.5. Justification of Specifications		X
	S.5. Reference Standards or Materials		√
	S.6. Container Closure System		X
	S.7. Stability		√
	P. DRUG PRODUCT
	P.1. Description and Composition		√
	P.2. Pharmaceutical Development		X
	2.1. Information on Development Studies		X
	2.2. Components of the Drug Product		√
	2.3. Finished Product		√
	2.4. Manufacturing Process Development		X
	2.5. Container Closure System		√
	2.6. Microbiological Antributes		√
	2.7. Compatibility		√
	P.3. Manufacture
	Formula for the Smallest Unit: name and quantity of all active and inactive ingredients
	3.1. Batch Formula		√
	List of Equipment used in Manufacturing andPackaging Process		√
	Flow Chart of Manufacturing and Packaging Process		√
	3.2. Manufacturing Process and Process Control		√
	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		X
	P.5. Control of Finished Product
	5.1. Specification		√
	5.2. Analytical procedures		√
	5.3. Validation of Analytical Procedures		√
	5.4. Batch Analysis		X
	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		(comply requirements under Circular 08/2010/TT-BYT)
D	Certificate of analysis: – for finished product – for excipient which has non- compendial specification		√√
E	Reference documents		X
F	Master file of manufacturer (Form 4/TT)In case a product undergoes many manufacturing stages, the master file should be the general one including all manufacturers involving in the production prior to marketing of the product		√
G	Bioequivalent and Bio Availability report under Circular 08/2010/TT-BYT		√
H	Brief of product in Vietnamese – Form 7B		√