[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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The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. Common Technical Document Consists guideelines the following Modules with the guidlines of the. We can provide these documents as per company requirement. January 1, DOI: 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.
REGULATORY DOSSIER- ASEAN COMMON TECHNICAL DOCUMENT (ACTD) FOR ASEM COUNTRIES | Zenodo
A NeeS format submission can normally be started with any initial, variation or renewal MA submission. This DOI represents all versions, and will always resolve to the latest one.
ACTD format significantly reduce the time and resources needed to compile applications for registration. The attitudes and actions of Regulatory Atcd Professionals will condition the perceptions of the government officials to the company.
Sravanthi The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. Different Regulatory Authority guidepines their Standard format according to country Guidelines. The drug manufacturer has to submit the drug dossier in eCTD format. 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.
Guidelinez can cite all versions by using the DOI Good for startup companies or scale up companies. The eCTD is an interface for the pharmaceutical industry to transfer regulatory information with various regulatory agencies.
ACTD/ATR Drug Registration Requirements
This guideline merely demonstrates an appropriate write-up format for acquired data. Common Pharmaceutical Dossier which is widely used in the Pharmaceutical Industry are: Dossier is a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. January 1, Journal article Open Access. Once the switch to this tuidelines format is made it is expected that further applications and responses relating to the particular medicinal product are submitted in NeeS format.
ASEAN Common Technical Dossier (ACTD)
Versions Version 1 Asian Common Technical Documents consists of following parts. Regulatory reviews and communication with the applicant is facilitated by a standard document of common elements.
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 guidleines results upon pharmaceutical registration.
This guideline merely demonstrates an appropriate write-up format for acquired data. All versions This version Views Downloads Data volume