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  • [Reporter¡¯s View]Year of regulations, principle vs practice
  • by Kim, Jin-Gu | translator Alice Kang | Jan 5, 2022 05:57am
In celebration of the TIger's Year, the industry should look back on its principles and practice to right the wrong
As in every other year, regulations imposed on the pharmaceutical and biopharmaceutical industry are again expected to be further reinforced this year.

In particular, GMP-related regulations will be strengthened even further. Starting this month, the government may impose punitive fines on the arbitrary manufacture of pharmaceuticals by companies.

In addition, the government and the National Assembly are pushing to amend the law so that an assigned GMP investigator could conduct on-site investigations on drug manufacturing plants. Also, a bill to revise the law to allow business suspension dispositions up to one year and license revocations in case of GMP violations is pending at the National Assembly.

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