Table 4.

The regulations/guidelines of PMS for CGTPs in South Korea

	Regulations/guidelines	Main topics
1	Pharmaceutical Affairs Act[101]	General regulation
2	Regulation for pharmaceutical approvals, notifications and reviews [106]	Approval, notification and review
3	Regulation on the execution of re-evaluation of pharmaceuticals [53]	Re-evaluation
4	Standard for re-examination of new drugs [105]	Re-examination
5	Regulation on safety information control of medicinal products [107]	Collection of safety information
6	Enforcement Decree of the Pharmaceutical Affairs Act [108]	Distribution, exaggerated advertising and collection and testing
7	Guideline on re-examination affairs of new drug, etc. [51]	Re-examination