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

The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. The attitudes and actions of Regulatory Affairs Professionals will condition the perceptions of the government officials to the company. Dossier is a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. This guideline merely demonstrates an appropriate write-up format for acquired data. 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. This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. 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. ICH‐ECTD is an internationally driven standard designed to reduce cost in the administration, assessment and archiving of applications for marketing authorization of medicinal products for human use, to reduce the use of paper and streamline the assessment process making the system more efficient.