The Pharma Journal

Introduction:  The Association of Southeast Asian Nations (more commonly known as ASEAN ) is a political and economic organization aimed primarily at promoting economic growth and regional stability among its members.  Asia’s regulatory systems are diverse, and oftentimes challenging to navigate. The regulatory agency in each Asian country has its own set of regulations and customary manner of conducting business. The following show the various Regulatory Authorities in each countries responsible for registration of medicines:- COUNTRY REGULATORY AGENCY INDONESIA NATIONAL AGENCY OF DRUG AND FOOD CONTROL MALAYSIA DRUG CONTROL AUTHORITY, NCE UNIT PHILIPPINES DEPARTMENT OF HEALTH THAILAND THAI FDA CONTROL DIVISION SINGAPORE HEALTH SCIENCES AUTHORITY BRUNEI MINISTRY OF HEALTH VIETNAM DRUG ADMINISTRATION OF VIETNA...

Common Technical Document is defined as a set of specifications which is used for making any application for registration of medicines. This system is used across US,EU and Japan Australia etc. CTD is maintained by  International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The main purpose of this Document set is to combine all safety, efficacy and quality data which are required for regulatory review process by Authorities ultimately for approval of drug registration.             As we are in 2020, The hard copy of documents are not practical in majority countries. All the submissions to the Regulatory Authority shall be done through various eCTD software's  online. The harmonized CTD specifications are given by ICH guidelines ( Multidisciplinary  guidelines  M4 ).                     The eCTD is defined as an interface for in...