ACTD

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The ASEAN Common Technical Document is organized into four parts.
Part I.  Table of Contents, Administrative Data and Product Information
Part I contains initially the overall Table of Contents of the whole ACTD to provide basically the information that could be looked through respectively. Secondly, the next content is the Administrative Data where required specific documentation in details is put together such as application forms, label, and package insert etc. The last section of this part is Product Information where necessary information includes prescribed information, mode of action, side effects etc.
A.        Introduction
B.        Table of Contents
C.        Administrative Data and Product Information
1.         Application Form
2.         Letter of Authorization
3.         Certifications
4.         Labelling
5.         Product Information
Part II. Quality Document
Part II should provide the Overall Summary followed by the Study Reports. The quality control document should be described in details as much as possible.
Section A: Quality Overall Summary (QOS): Table I gives a view of the Quality Overall Summary of Part II of ACTD.
Table I: Quality Overall Summary of Part II of ACTD
S DRUG SUBSTANCE
P DRUG PRODUCT
S1   General Information
P1   Description and Composition
S2   Manufacture
P2   Pharmaceutical Development
S3   Characterization
P3   Manufacture
S4   Control of Drug Substance
P4   Control of excipients
S5   Reference Standards or Materials
P5  Control of Finished Product
S6   Container Closure
P6   Reference Standards or Materials
S7   Stability
P7   Container Closure

P8   Stability

P9   Product Interchangeability Equivalence          evidence
Section B: Table of Contents
Section C: Body of Data
Part III. Nonclinical Document
Part III should provide the Nonclinical Overview, followed by the Nonclinical Written Summaries and the Nonclinical Tabulated Summaries. The document of this part is not required for Generic Products, Minor Variation Products and some Major Variation Products. For ASEAN member countries, the Study Reports of this part may not be required for NCE, Biotechnological Products and other Major Variation Products if the Original Products are already registered and approved for market authorization in Reference Countries.

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