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March 8, 2026
Approximately 5 minutes
Re-examination Periods for Prescription Drugs Under the Amendment Act
1. Background
The re-examination period of prescription drugs is based on prior notifications such as the 1993 Notification by Director-General (PAB Notification No. 725 dated August 25, 1993), Joint Notification by Directors (Joint PAB/NDD Notification No. 92 dated October 1, 1993), 2000 Notification by Director-General (PMSB Notification No. 1324 dated December 27, 2000), Notification by Director (PMSB/ELD Notification No. 1813 dated December 27, 2000), and PFSB Notification No. 0401001 dated April 1, 2007. The Amendment Act (Act No. 63 of 2019) was promulgated on December 4, 2019, and takes effect from September 1, 2020, introducing a designation system for drugs for specific use, leading to updated re-examination periods. The 1993 Notification by Director-General, Joint Notification by Directors, and third note in the 2000 Notification by Director-General are abolished. This notification applies from September 1, 2020. https://www.pmda.go.jp/files/000268674.pdf
2. Purpose
To determine and inform the re-examination periods for prescription drugs in light of the Amendment Act's designation system for drugs for specific use. https://www.pmda.go.jp/files/000268674.pdf
3. Revisions to Re-examination Periods for Orphan Drugs
For new drugs meeting >6 years to ≤10 years period: (A) Orphan drugs are included under separately specified periods. Re-examination must be conducted within 3 months after the investigation period. https://www.pmda.go.jp/files/000268674.pdf
4. Eligibility for Extensions
New drugs that meet the following are eligible: (1) >6 years to ≤10 years for orphan drugs (A), innovative drugs (B, designated under the SAKIGAKE system), and other drugs (C) designated by the Minister after hearing the Pharmaceutical Affairs and Food Sanitation Council; (2) <6 years for drugs for specific use (A), drugs clearly different in indications (B), and other designated drugs (C); (3) Other new drugs not listed above have a 6-year period. Drugs equivalent to new drugs in active ingredients, contents, administration, dosage, indications, efficacy, etc., approved during the investigation period must be re-examined within a period designated by the Minister to coincide with the new drug's re-examination. https://www.pmda.go.jp/files/000268674.pdf
5. Post-approval Obligations
Re-examination must be conducted within 3 months after the specified investigation period for applicable new drugs. For details, separate notifications should be referred to. https://www.pmda.go.jp/files/000268674.pdf
6. Effective Date
This notification shall apply from September 1, 2020. https://www.pmda.go.jp/files/000268674.pdf
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