A Comparative Study on Regulatory Requirements for Pharmaceutical and Biological Product registration in ASEAN and Asia Pacific Region for Parenteral Dosage Form

Abstract

Regulatory requirements for pharmaceutical and biological product registration varies significantly across different regions impacting availability of critical parenteral dosage form in that market. This thesis provides a comprehensive comparative analysis of regulatory requirements for registration of parenteral dosage form in emerging markets which include ASEAN and Asia – Pacific region.

The study majorly examines key regulatory framework, submission requirement, review process and lifecycle management. Focusing on how these factors affect development and market entry of parenteral product. The research explores major difference in documentation, quality requirements and product life cycle management across these markets. Data for the study is gathered from extensive review of official regulatory documents and guidelines.

Parenteral means ‘Para’ + ‘Enteral’ which means those products that surpasses the intestine and directly enters into systemic circulation. The pharmaceutical parenteral products are derived from synthetic or plant-based API’s whereas biological parenteral products are derived from organisms. This thesis covers all types of parenteral registration requirements including, branded, generic and biosimilar. It includes vaccines, pre-filled syringes, bottles, vials, bags, ampoules, etc.

Aim behind considering RoW market is that they are constantly updating and emerging themselves against regulatory challenges. Some of the countries in these regions have adopted ICH guidelines and others maintain unique regional guidelines. Some countries in region like ASEAN follow ACTD. Few countries like India to reduce the task of handling hard copy have established portals while few have established soft copy submission in CD/DVD or USB form while other still need submission in hard copy.