Links to major regulatory information of Other Products.
Regulations and Notifications
Generic Products
[Bioequivalence Study]
September 14, 2021 PSEHB/PED Administrative Notice
Ethical Kanpo Formulations
July 19, 2021 PSEHB/PED Administrative Notice
Over-the-counter (OTC) and Behind-the-counter (BTC) Drugs
[The Standards of Marketing Approval]
March 28, 2016 Administrative Notice
December 14, 2015 Administrative Notice
September 29, 2015 Administrative Notice
March 25, 2015 Notification PB No.28
March 25, 2015 Notification PB No.30
March 25, 2015 Notification PB No.26(March 28, 2016 Partial revision)
March 25, 2015 Notification PB No.23 (December 14, 2015 Partial revision)
April 22, 1980 Notification PFSB No.520(March 28, 1986, Final Revision)
May 17, 1982 Notification PB No.463 (May 15, 1998, Final Revision)
June 1, 1984 Notification PB No.381
July 29, 1986 Notification PB No.623
February 1, 1985 Notification PB No.90(March 22, 1995 Final revision)
February 1, 1988 Notification PB No.94 (May 15, 1998 Final revision)
March 28, 1989 Notification PB No.300(May 15, 1998, Final Revision)
February 1, 1991 Notification PB No.109(January 19, 2012 Final revision)
- (Appendix 13) The Standards for Marketing Approval of Antihemorrhoids (External Preparations)[139KB]
March 22, 1995 Notification PFSB No.277
May 15, 1998 Notification PSB No.447
November 1, 2011 Notification PFSB No.1101-1