ACTD: BRIDGE BETWEEN REGULATORY REQUIREMENTS OF DEVELOPED AND DEVELOPING COUNTRIES

Abstract

Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review andultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provide asafe, effective and low cost which benefits the society. Filing requirements in developed countries differ fromdeveloping countries which makes the approval process tedious and time consuming for the later. To make thisprocess 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 boththe guidelines can be minimized. This article focuses on the similarities and differences in between CTD & ACTDand highlights how ACTD can be a initiating step for developing countries to meet pharmaceutical regulations ofdeveloped countries.