What is ACTD Dossier?
The ASEAN Common Technical Dossier (ACTD) dossier is an instruction/guideline of the commonly convinced upon format for the groundwork of coherent Common Technical Dossier (CTD) applications submitted to ASEAN regulatory establishment for the registration of Pharmaceuticals for human consumption. The ACTD explains that how a CTD will drastically ease the time and resources required assembling applications for registration, and also, that it will decrease the groundwork for electronic document submissions.
The ACTD dossier explains an suitable write-up format for obtained data. However, it may be mended by the applicants to cast the finest possible presentation of technical info, in order to make possible the comprehending and assessment of the outcome upon pharmaceutical registration.
The exhibit of information must be explicit, clear-cut and obvious so that the reviewer can easily access the applicant’s contents and is able to review the essential data without any hitch. Margins must be used whilst creating text and margins at all times. It gives a levy while taking out printouts, it can be done either on a A4 sized sheet or a 8.5 x 11 size sheet. Specifically, the margin on the left-hand side must be large and wider so that the content isn’t cut whilst binding. The font type and font size must be Times New Roman and 12-point respectively. For text and tables, the font size should be large enough to be readable even after photocopying. Numbering of every page is must. If and when a Common Technical Acronym or abbreviations is used, it must be defined the first time when used, thereafter, the short form may be used.
The 1979 Vancouver Declaration on Uniform Requirements must be kept in mind as references while submitting manuscripts to Biomedical Journals.