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

The 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

Agency in Human-Smart Device Relationships: An Exploratory Study

In this paper, we investigate the relationship people have with their smart devices. We use the concept of agency to capture aspects of users’ sense of mastery as they relate to their device. This study gives preliminary evidence of the existence of two independent dimensions of agency for modeling the interaction between humans and smart devices: (i) user agency and (ii) device agency. These constructs emerged from an exploratory factorial analysis conducted on a survey data collected from 587 participants. In addition, we investigate the correlation between user agency and device agency with background variables of the respondents. Finally, we argue that mapping the users’ dynamics with their device into user agency and device agency fosters a better understanding of the needs of the users and helps in designing interfaces tailored for the specific capabilities and expectations of the users.

Agency in Human-Smart Device Relationships: An Exploratory Study

In this paper, we investigate the relationship people have with their smart devices. We use the concept of agency to capture aspects of users’ sense of mastery as they relate to their device. This study gives preliminary evidence of the existence of two independent dimensions of agency for modeling the interaction between humans and smart devices: (i) user agency and (ii) device agency. These constructs emerged from an exploratory factorial analysis conducted on a survey data collected from 587 participants. In addition, we investigate the correlation between user agency and device agency with background variables of the respondents. Finally, we argue that mapping the users’ dynamics with their device into user agency and device agency fosters a better understanding of the needs of the users and helps in designing interfaces tailored for the specific capabilities and expectations of the users.

COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA

A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study covers the introduction to generic drugs, and JAPAN & CHINA regulatory authorities. It also includes the requirements and registration of Generic Drugs in above specified countries. It also includes the checklist for comparative study of regulatory requirements and registration process of generic drugs in JAPAN & CHINA. JAPAN and CHINA are two different markets which are important to pharmaceutical industry. Japan is under one of the Regulated markets and owning the world’s second largest pharmaceutical market. Whereas China is under the Emerging market, but unfortunately these two are un trapped markets in the Pharma hub. So, am enthusiastic to know about Regulatory considerations and Registration process of Generic Drugs.