Insight on PMDA Regulatory Procedures, Key Stages, Timing, and CMC Requirements for Bio-Therapeutic Products in Japan

Abstract

T he purpose of this manuscript is to provide a basic understanding of legal regulatory systems, marketing authorization application, the Pharmaceutical and Medical Device Agency (PMDA) review process, key stages and timing and CMC (Chemistry, Manufacturing and Controls) requirements in Japan, with a focus on biotherapeutic/biological drug products for human use. The PMDA has some stringent CMC data requirements, which make Japan unique. Japan’s regulatory environment is significantly more complicated than any other country. The level of accuracy and details required by the Japanese regulatory authority is sometimes even greater than the US FDA (the United States Food and Drug Administration), the EMA (the European Medicine Agency) or any other pharmaceutical regulatory agency. 

Global biopharma companies often complete their development for US/EU markets before considering Japan. It is clearly an important part of the drug development process and Japan needs to be considered in parallel with activities required for other major regulatory authorities (USFDA and EMA). In context, another significant consideration is that approval for a drug product in the US/EU is a well-understood and documented process, whereas Japanese approvals are often more complicated, unclear and time consuming. Here, the author has studied various unique features and the challenging regulatory framework for biopharmaceutical products, including regulatory procedures, registration, authority review, compliance, approval, and a key focus on CMC requirements. The proposal is to identify priority measures and controls that companies should have in place in order to build quality into procedures for compiling flawless regulatory submissions and to reduce review time by minimizing regulatory queries. This also provides a way for overseas manufacturers for development of bio prescription drugs for the Japanese market and provides a brief of precise requirements.