Ready for ICSR reporting
in the new E2B(R3) standard?
With the introduction of IDMP standards, the Republic of Korea expect national drug codes to be submitted for domestic adverse drug reaction (ADR) cases and WHODrug Global MPID and CAS numbers for international ADR cases. WHODrug Link Korea provides a bridge between WHODrug Global codes and applicable local drug codes, effectively facilitating E2B(R3) compliance for domestic cases.
WHODrug Link Korea
bridges the gap for:
Multinational or domestic Marketing Authorisation Holders (MAHs) performing drug coding with WHODrug Global that need to report drug information for ADR cases to the Republic of Korea’s Ministry of Food and Drug Safety (MFDS)
Service providers offering drug coding services to MAHs active in the Korean market
Vendors hosting pharmacovigilance platforms supporting E2B(R3) submissions to the MFDS
Key features
Link to Korea
Provides mappings between WHODrug Global codes and Korean drug codes for both B3 and C3 format users
Updated regularly
New versions of mappings with Korean drug codes released twice a year (in March and September) along with WHODrug Global
Increased efficiency
Reduces the need for manual double coding by matching WHODrug codes to Korean standard product codes and WHODrug CAS numbers to Korean substance codes
Streamlined coding
Can be implemented within pharmacovigilance platforms. Please click here for implementation statements from vendors
How to subscribe
WHODrug Link Korea is available as an add-on subscription to the WHODrug Global licence. Contact us to upgrade your existing subscription or for more information.
FAQ
How can I practically make use of WHODrug Link Korea?
Our recommendation is for WHODrug Link Korea to be implemented directly in pharmacovigilance platforms for maximum effectiveness. Please check with your platform provider for information on implementation plans.
Alternatively, WHODrug Link Korea can be used as a lookup table (for example, in Microsoft Excel) for manual code conversion.
What format is WHODrug Link Korea provided in?
WHODrug Link Korea is available both as .txt and .csv files.
What mappings are included in
WHODrug Link Korea?
WHODrug Link Korea provides mappings to Korean substance codes as well as Korean standard product codes.
Is it mandatory to use WHODrug
to meet Korean regulations?
No, there are no regulatory requirements specifically stating that WHODrug Link Korea is required for identifying and submitting Korean drug codes. Drug information (including local drug codes) for Korean medicinal products can be found on the Korean Ministry of Food and Drug Safety’s website.
Are all Korean medicinal products represented in WHODrug Link Korea?
While aiming to cover a majority of the approved medicinal products within the Republic of Korea in WHODrug Link Korea, the mapping process follows strict guidelines and mapping conventions, and only mappings which accord with those policies are included in WHODrug Link Korea. Unmapped Korean drug codes are not included in WHODrug Link Korea and will need to be identified manually.
Are all mappings provided as one-to-one?
No. Due to the nature of Korean drug codes, WHODrug Link Korea contains a mix of one-to-one and one-to-many mappings. Additional information on medicinal products is included in the files to facilitate the manual selection process for one-to-many mappings.
Are sample files available?
Yes. Sample files can be provided to all WHODrug users upon request. Please contact us for further assistance.