ACTD: Bridge between Regulatory Requirements of Developed and Developing Countries

Jain Achin ； Venkatesh M. P. ； Kumar Pramod T. M.

《International Journal of Drug Regulatory Affairs》 1卷4期 (2013/12) Pp. 1-11

並列摘要

Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review and ultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provide a safe, effective and low cost which benefits the society. Filing requirements in developed countries differ from developing countries which makes the approval process tedious and time consuming for the later. To make this process smooth, ASEAN CTD (ACTD) was developed by Association of South East Asian Nations (ASEAN) nations. As format of ACTD resembles the format of Common Technical Document (CTD) with some differences, hence it can be used as a step. Also if both guidelines can be harmonized then differences and variation between both the guidelines can be minimized. This article focuses on the similarities and differences in between CTD & ACTD and highlights how ACTD can be a initiating step for developing countries to meet pharmaceutical regulations of developed countries.

並列關鍵字

ACTD ； ASEAN ； CTD ； eCTD ； ICH