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 Nat