Japan Master File

Japan Master File (MF) is a regulatory system managed by the PhArmaceuticals and Medical Devices Agency (PMDA) in Japan. It allows companies to register detAIls of raw materials, intermediates, and other components used in drug manufACTuring, which can then be referenced by marketing authorization holders in their APPlications. This system is not an AI tool but a specialized Database for pharmaceutical regulatory affairs.

What it does

The Master File system enables the confIDEntial registration of Information about drug substances, intermediates, and materials. When a drug application is subMITted, the applicant can refer to the registered Master File without having to disclose the proprietary details directly. PMDA reviews the Master File as part of the drug approval process. The system is accessible via the PMDA website and includes guidelines and procedures for registration.

Key capabilities

• Confidential registration: Companies can register detailed infORMation about their products without revealing trade SECrets to applicants.
• Regulatory reference: Marketing authorization holders can cite Master Files in their applications, streamlining the review process.
• Public information: The system provides public access to some Master File information, such as the fact that a file exists, while protecting confidential data.
• Guidance and documentation: The PMDA website offers guidance documents, application forms, and procedures for using the Master File system.

Who it is for

This tool is intended for pharmaceutical companies, regulatory affairs Professionals, and manufacturers of drug substances and intermediates who need to comply with Japanese regulatory requirements. It is also relevant for organizations planning to market drugs in Japan and needing to reference Master Files in their applications.

How to get started

To use the Japan Master File system, you should first review the PMDA website's guidance on Master Files. The process typically involves preparing the necessary documentation, submitting an application for registration, and paying any required fees (which may vary). Access to the system is through the PMDA website, and some features may require registration or specific procedures.

Pricing and access caveat

The Japan Master File system itself is free to access, but there may be fees associated with the registration and review process for Master Files. These fees can vary depending on the type of file and the services required. Users should consult the PMDA official website for the most current fee schedule and Detailed procedures. Note that this system is not an AI product but a regulatory database, and its availability and features may change over time.