Others

Links to major regulatory information of Other Products.

Regulations and Notifications

Generic Products

[Bioequivalence Study]

• English Translations of Guidelines for Bioequivalence Studies of Generic Products[362.45KB]

September 14, 2021 PSEHB/PED Administrative Notice

Ethical Kanpo Formulations

• Basic Concept on Bioequivalence Evaluation for Addition of Formulations with Different Dosage Forms in Ethical Kampo Formulations[416.05KB]

July 19, 2021 PSEHB/PED Administrative Notice

Over-the-counter (OTC) and Behind-the-counter (BTC) Drugs

[The Standards of Marketing Approval]

• Partial revision of "English version of the Standards for Marketing Approval of Cold Remedies, etc”[381KB]

March 28, 2016 Administrative Notice

• Partial revision of "English version of the Standards for Marketing Approval of Cold Remedies, etc"[134KB]

December 14, 2015 Administrative Notice

• English version of the Standards for Marketing Approval of Cold Remedies, etc.[1.43MB]

September 29, 2015 Administrative Notice

• (Appendix 1) The Standards for Marketing Approval of Cold Remedies196KB]

March 25, 2015 Notification PB No.28

• (Appendix 2) The Standards for Marketing Approval of Antipyretic Analgesics[86.2KB]

March 25, 2015 Notification PB No.30

• (Appendix 3) The Standards for Marketing Approval of Antitussives and Expectorants[165KB]

March 25, 2015 Notification PB No.26(March 28, 2016 Partial revision)

• (Appendix 4) The Standards for Marketing Approval of Oral Remedies for Rhinitis[50.1KB]

March 25, 2015 Notification PB No.23 (December 14, 2015 Partial revision)

• (Appendix 5) The Standards for Marketing Approval of Gastrointestinal Medicines[229KB]

April 22, 1980 Notification PFSB No.520(March 28, 1986, Final Revision)

• (Appendix 6) The Standards for Marketing Approval of Laxatives[190KB]

May 17, 1982 Notification PB No.463 (May 15, 1998, Final Revision)

• (Appendix 7) The Standards for Marketing Approval of Antivertigo Medicines[107KB]

June 1, 1984 Notification PB No.381

• (Appendix 8) The Standards for Marketing Approval of Ophthalmic Medicines[140KB]

July 29, 1986 Notification PB No.623

• (Appendix 9) The Standards for Marketing Approval of Vitamin Preparations[202KB]

February 1, 1985 Notification PB No.90(March 22, 1995 Final revision)

• (Appendix 10) The Standards for Marketing Approval of Enemas[94.7KB]

February 1, 1988 Notification PB No.94 (May 15, 1998 Final revision)

• (Appendix 11) The Standards for Marketing Approval of Anthelmintics[122KB]

March 28, 1989 Notification PB No.300(May 15, 1998, Final Revision)

• (Appendix 12) The Standards for Marketing Approval of Nasal Drops for Rhinitis[37.9KB]

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

• (Appendix 14) The Standards Marketing Approval of Athlete’s Foot and Ringworm Remedies[129KB]

May 15, 1998 Notification PSB No.447

• (Appendix 15) The Standards for Marketing Approval of Antipruritic and Anti-inflammatory Drugs[53.1KB]

November 1, 2011 Notification PFSB No.1101-1