Unapproved Drug / Off-Label Use Labeling｜Database Construction Services｜General Incorporated Foundation International Medical Information Center (IMIC)

To ensure you don’t miss any literature on unapproved drugs and off-label use.

With today's pharmaceutical industry required to operate in strict alignment with the Guidelines for Providing Sales Information, we provide comprehensive labeling (tagging) of literature data and product FAQs to ensure information on unapproved drugs and off-label use is never overlooked.
Our services also integrate with your existing literature databases. Our specialized staff will fully support the construction of a highly precise internal information infrastructure.

ABOUT

Overview of Unapproved Drug / Off-Label Use Labeling

We manage the labeling (tagging) of your accumulated literature and product FAQ data on your behalf, helping you adhere to the "Guidelines for Providing Sales Information on Prescription Drugs" and mitigate the risk of regulatory violations. This service significantly reduces your internal workload and supports smooth information provision activities.
Information can also be updated seamlessly whenever package inserts are revised.
By maintaining a consistently up-to-date and appropriate information delivery system, we help your company achieve both enhanced compliance and operational efficiency.

Unapproved drugs: Drugs that have been approved for marketing overseas but not in Japan.
Off-label use: The use of a drug approved in Japan for therapeutic purposes in a manner that differs from its approved indications, dosage, or administration method.

Service Details

This service involves labeling (tagging) literature data and product FAQ (Q&A) data with information on unapproved drugs and off-label uses.
This enables centralized management of the latest and most accurate information, streamlining literature searches and enhancing compliance.

Features and Strengths

We apply labels for unapproved drugs and off-label use, significantly improving searchability.
Accurate labeling (tagging) is performed by our team of medical and pharmaceutical experts.
We also provide consulting services, including the development of literature databases.

Service and Delivery Options

We can accommodate one-off requests.
We can flexibly accommodate your preferred delivery format.
We can also manage data using the tagging feature within the literature integration database developed exclusively by IMIC.

IMIC Document Information System
（I-dis）

FAQ

FAQ for Unapproved Drug / Off-Label Use Labeling

What types of literature can you review?

In addition to literature already registered in your database, we also accept literature information newly retrieved from commercial databases, literature information collected from academic journals and conference proceedings, and labeling (tagging) of literature provided by clients.

How long does it take from request to delivery? Can we get a quote?

We will discuss your requirements during a consultation and propose specifications, a delivery schedule, and a quote.

Click here for the inquiry form

What delivery formats are available?

We can deliver in your preferred format, such as Word, Excel, or text files.

Do you accept periodic requests or one-time requests?

We handle both periodic and one-time requests. For periodic requests, we also provide support when the package inserts are revised.