ACTD GUIDELINES PDF

[email protected] Overview of Dossier Requirements and Guidelines for Generic Product Muhammad Ali email: [email protected] ACTD: ASEAN COMMON TECHNICAL DOCUMENT AND . b) Sections of ASEAN Common technical dossier c) ACTD Guideline; 3. the discussion of existing technical guidelines and regulatory requirements;; the study of harmonised procedures and regulatory systems currently implemented.

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ASEAN Common Technical Dossier (ACTD)

A NeeS format submission can normally be started with any initial, variation or renewal MA guuidelines. Throughout the ACTD, the display of information should be unambiguous and transparent, in order to facilitate the review of the basic data and to help a reviewer become quickly oriented to the application contents.

The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. Asian Common Technical Documents consists of following parts. The attitudes and actions of Regulatory Affairs Professionals will condition the perceptions of the government officials to the company.

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ACTD format significantly reduce the time and resources needed to compile applications for registration. All versions This version Acd Downloads Data volume Once the switch to this electronic format is made it is expected that further applications and responses relating to the particular medicinal product are submitted in NeeS format.

This guideline merely demonstrates an appropriate write-up format for acquired data.

ASEAN Common Technical Dossier (ACTD) – ASEAN | ONE VISION ONE IDENTITY ONE COMMUNITY

Common Technical Document Consists of the following Modules with the number of the. We can provide these documents as per company requirement.

This DOI represents all versions, and will always resolve to guideoines latest one. The eCTD is an interface for the pharmaceutical industry to transfer regulatory information with various regulatory agencies.

Regulatory reviews and communication with the applicant is facilitated guidleines a yuidelines document of common elements. Versions Version 1 Common Pharmaceutical Dossier which is widely used in the Pharmaceutical Industry are: Different Regulatory Authority published their Standard format according to country Guidelines. This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions.

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The drug manufacturer has to submit the drug dossier in eCTD format. January 1, Journal article Open Access.

REGULATORY DOSSIER- ASEAN COMMON TECHNICAL DOCUMENT (ACTD) FOR ASEM COUNTRIES | Zenodo

January 1, DOI: Good for startup companies or scale up companies. You can cite all versions by using the DOI Sravanthi The Regulatory Affairs department is very often the first point of contact between the government authorities and the company.

However,applicants can modify, if needed, to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results upon pharmaceutical registration. Dossier is a collection or file of documents on guiddlines same subject, especially a file containing detailed information about a person or a topic.

This guideline merely demonstrates an appropriate write-up format for acquired data.