Stages in Approval Process

The life cycle of any of the regulated medicinal products in Japan commonly consist of a number of mostly consequent stages starting with the discovery and ending with withdrawal from the market. Those stages are covered in two different ways in the publications of Jouhou Koukai Publishing:

1. Development stages from Discovery to Reevaluation & Reexamination - described in documents and reports predominantly from the point of sponsors (for detailed information and list of publications, visit the JKS Document Store
2. Regulatory stages - used in JAD Databases. Under the structural convention applied in JAD Databases, the Regulatory stages begin with Preparation for submission (when the sponsors start evaluating their data and thence the approvability of the product against the regulatory requirements) and end with a withdrawal (voluntary or ordered). The Regulatory stages are listed below and each is covered in various JAD Databases
   

The "Stage Indicator" has been introduced in JAD Database to quantify the progress in approval flow from the date of submission through the approval. For the purpose of JAD Databases selected 6 stages from the life cycle of medicinal products in Japan are covered. Each of the six stages has an "Stage Indicator" assigned as a numerical equivalent ranging from 0 to 24, as shown in the table below.

The Stage Indicator is included in both data and graphical part of JAD Submitted for Approval (JAD-SUB) database. The numerical equivalent assigned to each stage makes visually clear the changes from one stage to another as the product progresses in the approval process.