Drugs that are approved for effectiveness	Drugs that can be approved for effectiveness with partial revision of matters to be approved	Drugs that are not approved for effectiveness
Number of ingredients	Number of items	Number of ingredients	Number of items	Number of ingredients	Number of items
1,179	3,228	50	142	0	0

(As of the end of FY2013)

Source: Pharmaceutical and Food Safety Bureau, MHLW

Detailed Data 2 Results of Prescription Drug Re-evaluation

(As of the end of FY2013)

Comprehensive evaluation (number of items)
Drugs that are approved for effectiveness	Drugs that can be approved for effectiveness with partial revision of matters to be approved	Drugs that are not approved for effectiveness	Drugs that the applicants made adjustments on matters to be approved after filing re-evaluation application	Total
Phase 1 re-evaluation	11,098	7,330	1,116	305	19,849 (19,612)
Phase 2 re-evaluation	105	1,579	42	134	1,860
New re-evaluation	4,608	3,315	66	864	8,853

Source: Pharmaceutical and Food Safety Bureau, MHLW

(Note) 1. The figures in parentheses indicate those adjusted for cases where the same item was officially announced more than once.

2. Phase 1 re-evaluation: covers ingredients approved on or prior to September 30, 1967

3. Phase 2 re-evaluation: covers ingredients approved between October 1, 1967 and March 31, 1980

4. New re-evaluation: covers all ingredient

Detailed Data 3 Changes in the Number of Reports on Adverse Drug Reaction, etc. in the Past 5 Years

FY	Reports from marketing authorization holders	Reports on adverse drug reactions from medical professionals*
Reports on adverse drug reactions	Reports on infectious diseases	Reports on research results	Reports on overseas measures	Regular reports on infectious diseases
FY2009	30,814	114	933	930	1,108	6,181
FY2010	34,578	99	940	1,033	1,101	4,809
FY2011	36,641	100	841	1,347	1,089	5,231
FY2012	41,254	159	884	1,134	1,117	4,147
FY2013	38,329	98	962	1,317	1,138	5,420

* The figures for FY2009 to FY2012 include reports consolidated by MHLW on adverse reactions arising from voluntary inoculation of influenza vaccines (including novel type) or its inoculation with vaccination promotion project under the Preventive Vaccinations Act and those arising from emergency vaccination promotion projects involving cervical cancer prevention vaccines, Hib vaccines, and pneumococcus vaccines for children. From FY2013, reports on adverse drug reaction after taking preventive vaccination are included in “reports from medical institutions”.

Source: Pharmaceutical and Food Safety Bureau, MHLW

## Detailed Data 4

Changes in Number of Reports on Adverse Event Related to Medical Devices, etc. in the Past 5 Years

FY	Reports from marketing authorization holders	Reports on adverse event from medical professionals
Reports on adverse event $ * $	Reports on infectious diseases	Reports on research results	Reports on overseas measures	Regular reports on infectious diseases
FY2009	6,446	0	6	831	59	363
FY2010	14,811	0	27	978	58	374
FY2011	16,068	0	2	1,060	62	385
FY2012	22,234	0	3	1,337	69	522
FY2013	25,554	0	5	1,669	75	489

$ ^{*} $ Reports on adverse event include overseas cases.

Source: Pharmaceutical and Food Safety Bureau, MHLW