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【资料】泰国出口药品注册要求

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这个帖子发布于6年零259天前，其中的信息可能已发生改变或有所发展。

看了看大家发的帖子，美国注册，欧盟注册的文章比较多，其实很多亚洲国家对我国的药品需求量也很多，发一个出口泰国的药品注册要求。不知道有没有人需要。这个是外商发给我们的。
REGISTRATION REQUIREMENTS OF PHARMACEUTICAL PRODUCTS IN THAILANDASEAN COMMON TECHNICAL DOSSIER (ACTD)
Section A : Administrative data

1) referenceof leaflet
2) formula
3) dosageform and packaging
4) nameand address of manufacturing/marketing authorization holder
5) sampleof product
6) appearanceof product
7) certificateof pharmaceutical products (WHO form)
8) GMPcertificate
9) label
10) package insert(pharmacodynamics/pharmacokinetics, indication, recommended dose,
contraindication, warnings and precautions,interactions with other medicaments, undesirable effects, overdose andtreatment, storage condition, date of revision of package insert)

Part Quality

Section B : Quality overall summary

Drugsubstance

1) generalinformation
1.1) nomenclature
1.2)structure
1.3)general properties
2)manufacture
2.1)manufacturer
3)characterization
3.1)elucidation of structure and other characteristics
3.2)impurities
4)control of drug substance
4.1)specification and certificate of analysis
4.2)analytical procedures
4.3)validation of analytical procedures
5)reference standards or materials
6) stability

Product
1)description and composition
2)pharmaceutical development
2.1)components of the drug product
2.2)finished product
2.3)container closure system
2.4)microbiological attributes
2.5)compatibility
3)manufacture
3.1)batch formula
3.2)manufacturing process and process control
3.3)control of critical steps and intermediates
3.4)process validation and/or evaluation
4)control of excipients
4.1)specifications and certificate of analysis
4.2)analytical procedures
4.3)excipients of human or animal origin
5)control of finished product
5.1)specifications and certificate of analysis
5.2)analytical procedures
5.3)validation of analytical procedures
5.4)batch analyses
5.5)characterization of impurities
5.6)justification of specification
6)reference standards or materials
7)container closure system
8)stability
9)product interchangeability equivalence evidence

Section C : Body of data

Drugsubstance

1) generalinformation
1.1)nomenclature
1.2)structure
1.3)general properties
2)manufacture
2.1)manufacturer
3)characterization
3.1)elucidation of structure and other characteristics
3.2)impurities
4)control of drug substance
4.1)specification and certificate of analysis
4.2)analytical procedures
4.3)validation of analytical procedures
5)reference standards or materials
6)stability

Product

1)description and composition
2)pharmaceutical development
2.1)components of the drug product
2.1.1)active ingredients
2.1.2)excipients
2.2)finished product
2.2.1)formulation development
2.2.2)overages
2.2.3)physiochemical and biological properties
2.3)container closure system
2.4)microbiological attributes
2.5)compatibility
3)manufacture
3.1)batch formula
3.2)manufacturing process and process control
3.3)control of critical steps and intermediates
3.4)process validation and/or evaluation
4)control of excipients
4.1)specifications and certificate of analysis
4.2)analytical procedures
4.3)excipients of human or animal origin
5)control of finished product
5.1)specifications and certificate of analysis
5.2)analytical procedures
5.3)validation of analytical procedures
5.4)batch analyses
5.5)characterization of impurities
5.6)justification of specification
6)reference standards or materials
7)container closure system
8)stability
9)product interchangeability equivalence evidence

Info. from IRA (rearranged by VK)
Date: March 31, 2010