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  • Name of transferred and aquired drugs can be changed in KOR
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | May 9, 2024 05:52am
MFDS clarifies related regulations
MFDS will determine the conformity of product name changes during product approvals
The company may use the name of a drug that withdrew from the market in the case the drug¡¯s market withdrawal was due to mergers, acquisitions, or manufacturer status successions
Korea¡¯s regulations now stipulate that brand names of a drug transferred to a different company can be changed.

According to industry sources on the 7th, the Ministry of Food and Drug Safety recently announced the revision of the 'Casebook for Drug Product Naming Practices (Citizen's Guide)' and announced the allowance of brand name changes.

The MFDS changed the regulation that only allowed the company name of a product to be changed upon transfer of a drug that was specified in 2016 to allow the product name to be changed as well.

However, in response to inquiries from the pharmaceutical industry regarding the transferred drug¡¯s product name, the MFDS has been responding that "the product name is determined a
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