Drug Safety Information Database (SELIMIC)
Leverage proven safety information services built to global standards
SELIMIC (SafEty information Literature in IMIC) is a drug safety information database developed independently by IMIC, which collects domestic safety information on prescription drugs,
over-the-counter drugs, quasi-drugs, cosmetics, herbal medicines, and regenerative medicine products.
Launched in 1994 in response to requests from the medical industry following the enforcement of GPMSP, SELIMIC is currently utilized by numerous domestic and foreign-affiliated pharmaceutical companies.
ABOUT
Overview of the SELIMIC Database
SELIMIC (SafEty information Literature in IMIC) is IMIC’s proprietary literature and conference information database that collects safety information on pharmaceutical products (prescription drugs, over-the-counter drugs, quasi-drugs and cosmetics, and regenerative medicine products) from pharmaceutical-related journals published in Japan and pharmaceutical-related academic conferences and research meetings held in Japan.
Three reasons why SELIMIC is chosen
Extensive information sources
We cover approximately 600 domestic periodicals and approximately 3,000 program and abstract collections from academic societies and research groups, and we ensure comprehensiveness by regularly reviewing our sources.
High-quality drug safety information
Experienced experts review the full text of journal articles and conference abstracts, and under IMIC’s rigorous quality control system, we are building a highly reliable database of pharmaceutical safety information.
Global & Local compliance
In addition to Japan’s GVP Ministerial Ordinance, we comply with European and U.S. guidelines and collect information on special situations and ICSR reports. We have also consistently adapted to regulatory changes, such as those related to the reporting of safety issues with regenerative medicine products and combination products.
Information categories of SELIMIC
At SELIMIC, we index proprietary "Information Categories" for each pharmaceutical product appearing in the literature, based on domestic and international safety reporting standards. These information categories are directly mapped to the safety reporting requirements of each regulatory authority.
By specifying either "Domestic GVP" or "Global GVP" as your search criteria, we comprehensively retrieve the safety information required for the corresponding regulatory reports without the need to construct complex search queries.
Global GVP
Domestic GVP
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Adverse Events / Adverse Drug Reactions
(Infections) -
Lack of Efficacy
-
Drug Interaction
-
Potential Serious Risk
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Overdose, Misuse, and Abuse
-
Non-clinical Study (Animals / In Vitro)
-
Medication Error
-
Quality Defect
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Occupational Exposure
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Combination Product Malfunction
-
Change in Frequency of Adverse Reactions
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Malfunction or Defect of Regenerative Medical Products
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Drug Resistance
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Off-label Use
-
Special Situations
(Pediatrics, Adolescents, Pregnant Women, Breastfeeding Women) -
Suspected or Confirmed Medicinal Products
-
Ineffective Cases
SERVICE
SELIMIC Services (SELIMIC-Alert, SELIMIC Web)
SELIMIC-Alert (Domestic Drug Safety Information Service)
SELIMIC-Alert is an SDI (Selective Dissemination of Information) service powered by the SELIMIC database. We periodically run searches based on your specified drug names and search criteria (such as Domestic GVP, Global GVP, or custom settings) and deliver the results directly to you.
Full-text copies of the retrieved literature are also included in the delivery package. As an optional feature, we can even provide text files formatted for direct import into your in-house database!
Delivery Process
Advantages of Using Our Service
By using SELIMIC-Alert for domestic literature searches and “Overseas Drug Safety Information Service” for international literature searches, you can outsource both your domestic and international literature screening operations in one package.
Integrated management with overseas safety information
We provide comprehensive support for searching for international drug safety information. IMIC assists with every step of the safety information collection process, from database selection and search query design to ongoing maintenance.
Click here for Overseas Drug Safety Information ServiceIntegration with GVP operations
We also offer GVP services using SELIMIC-Alert.
By outsourcing these services together with overseas drug safety information, you can further streamline your operations.
SELIMIC Web
SELIMIC Web is an online literature search platform that allows you to search the SELIMIC database directly.
OTHER
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