PMDA (Pharmaceuticals and Medical Devices Agency)
Who regulates medicines in Japan?
In one sentence
The PMDA is Japan's medicines and devices agency: it reviews products and collects safety reports for the Ministry, which signs the decisions.
Set up on 1 April 2004 under the Ministry of Health, Labour and Welfare (MHLW), it does three jobs in one house: reviews, post-marketing safety, and the relief fund for people harmed by medicines. The Minister approves and orders; the PMDA reads, investigates and pays.
Where it sits
- MinistryThe Minister of Health, Labour and Welfare, who approves and orders
- CouncilPharmaceutical Affairs and Food Sanitation Council, which advises the Minister
- AgencyPMDA, an incorporated administrative agency that reviews and investigates
- ReportsCompanies and professionals report to the PMDAIt notifies the Minister without delay
Think of it like this
Think of a judge who signs every ruling, and the clerks’ office that reads the files and drafts it. In Japan the same office also runs the fund for the people a medicine has hurt.
Key insights
Under the Act a medicine is approved by the Minister, who “may have the PMDA conduct an examination”. Safety reports work the same way: the law addresses them to the Minister, the Minister routes them to the PMDA, and the PMDA must notify the Minister of what it finds without delay.
Reviews, post-marketing safety and relief for the injured, run as one risk-management system the PMDA calls the Safety Triangle. By its own account no other public agency anywhere does all three. Chapter 1 tells where the third job came from.
A serious case not in the package insert reaches the PMDA within 15 days, from Japan or abroad; a serious case already in the insert has 30 days. In fiscal 2024 companies filed 65,214 adverse reaction reports and health professionals 9,474. Chapter 2 sets the clocks.
With the Ministry, the PMDA is a founding regulatory member of the International Council for Harmonisation (ICH) and a member of the International Coalition of Medicines Regulatory Authorities (ICMRA). In 2024 it opened its first offices abroad, in Thailand and Washington.
Jump to: 1 Three moments 2 Your report, their clock 3 Side by side with Europe 4 Test yourself
Chapter 1
Which three moments made the PMDA what it is?
Pick a year. Each added one side of the triangle.
A fund born of two disasters
Thalidomide victims sued in 1963 and asked for a relief system; sufferers of subacute myelo-optico-neuropathy (SMON), the nerve disease caused by quinoform, sued in 1971. In October 1979 Japan set up the Fund for Adverse Drug Reaction Relief, and in May 1980 the Relief System for Sufferers from Adverse Drug Reactions began paying.
The companies that sell the medicines pay for the fund. In 1994 it became the Organization for Pharmaceutical Safety and Research, one of the three bodies that merged into the PMDA.
What it left behind: a regulator that pays as well as checks, and five relief services today.
Three bodies become one agency
A 2001 Cabinet plan to rationalise public corporations led to the Act on the Pharmaceuticals and Medical Devices Agency, and on 1 April 2004 the PMDA opened, taking over the relief organisation, the evaluation centre of the National Institute of Health Sciences and part of the medical equipment association.
Its legal form is an incorporated administrative agency whose staff are not civil servants. The signature stayed with the Minister: the Act says the Minister “may have the PMDA conduct an examination” for approval, and may have it compile and investigate the safety reports.
What it left behind: one address for applications and reports, and a Minister who still decides.
Twenty years, first offices abroad
On its twentieth anniversary, 1 April 2024, the PMDA adopted a new Purpose; on 1 July it opened an Asia Office in Thailand, its first base outside Japan, and on 1 November a Washington D.C. Office.
At home the safety work had already changed shape. Since fiscal 2018 the PMDA runs the Medical Information Database Network (MID-NET), hospitals’ electronic records it uses for pharmacoepidemiology next to the spontaneous reports. The agency has 1,091 staff.
What it left behind: a Japanese regulator with a desk in Bangkok and one in Washington.
Chapter 2
Your report, their clock
A case has reached your company. The Regulation sets the deadline with two questions: is it serious, and is it already in the package insert? Pick a cell.
Or you are not a company at all:
A serious case the precautions do not predict goes to the PMDA within 15 days, from Japan or abroad. Death is always 15 days, as is any serious case in a new active substance’s first two years or found through early post-marketing phase vigilance. Enforcement Regulation, Article 228-20(1)(i); Pharmaceuticals and Medical Devices Act (PMD Act), Article 68-10 and 68-13
A serious case the precautions already predict has 30 days, for cases in Japan. From abroad it is not sent one by one unless the trend changes. Enforcement Regulation, Article 228-20(1)(ii)
A non-serious case not in the precautions is not sent on its own. It goes into the periodic report: yearly for most medicines, on the re-examination schedule for new ones. Enforcement Regulation, Article 228-20(1)(iii)
A non-serious case already in the precautions is not on the list at all. Enforcement Regulation, Article 228-20(1)
The Act gives physicians, pharmacists and other professionals a duty to report a suspected case “when it is found to be necessary in order to prevent the occurrence or spread of hazards”. It sets no clock; the report goes to the PMDA for the Minister. PMD Act, Article 68-10(2) and 68-13(3)
The PMDA must notify the Minister of Health, Labour and Welfare of the results of such compilation of information or investigation without delay.
Pharmaceuticals and Medical Devices Act (PMD Act), Article 68-13(4): what the agency owes the Minister
In fiscal 2024 companies filed 65,214 adverse reaction reports for medicines and health professionals 9,474, all to the PMDA. The Minister puts the year’s reports before the Pharmaceutical Affairs and Food Sanitation Council and, on its advice, orders revisions of the precautions.
Chapter 3
Side by side with Europe
Japan runs its own rulebook. Five places where it differs from the European Union (EU).
| The EU rule | The Japanese rule | |
|---|---|---|
| Who decides | The European Commission, on the opinion of the European Medicines Agency (EMA), for centralised medicines | The Minister, on the PMDA’s review and the Council’s advice |
| Where a serious case goes | EudraVigilance within 15 days, wherever it happened | The PMDA: 15 days if the precautions do not predict it, from Japan or abroad; 30 days if they do, from Japan only |
| A non-serious case | 90 days if it happened in the Union | In the periodic report if not in the precautions; otherwise not reported |
| A doctor’s serious case | Reporting is encouraged | A duty under the Act when needed to prevent hazards, with no clock |
| The injured patient | Nothing in the pharmacovigilance rules | The PMDA runs a relief fund, paid for by company contributions, since 1980 |
Show the legal references
- Who decides: Regulation (EC) No 726/2004, Article 10(1); PMD Act, Articles 14(1), 14-2(1) and 68-12.
- Serious cases: Directive 2001/83/EC, Article 107(3); Enforcement Regulation, Article 228-20(1)(i) and (ii), and 228-23.
- Non-serious cases: Directive 2001/83/EC, Article 107(3); Enforcement Regulation, Article 228-20(1)(iii).
- Professionals: Directive 2001/83/EC, Article 102(a); PMD Act, Article 68-10(2).
- Relief: the PMDA relief services page and the Profile of Services brochure (history and flowchart).
Two questions, two clocks, one address: in Japan the case goes to the PMDA, and the Minister signs what follows.
The facts, in one place
| What it is | An incorporated administrative agency with non-civil service status under the Ministry of Health, Labour and Welfare, created by the Act on the Pharmaceuticals and Medical Devices Agency (Act No. 192 of 2002). |
|---|---|
| Since | 1 April 2004; its relief fund since October 1979. |
| Who decides | The Minister approves medicines and orders safety measures; a Chief Executive heads the agency. 1,091 staff in 2026. |
| Seat | Tokyo, Shin-Kasumigaseki Building, Kasumigaseki. |
| Fiscal 2024 in numbers | 65,214 adverse reaction reports from companies and 9,474 from health professionals for medicines. |
| Relief | Five services: adverse drug reactions, infections from biological products, and allowances for patients with subacute myelo-optico-neuropathy (SMON), the human immunodeficiency virus (HIV) or hepatitis C; company contributions pay for the drug fund. |
| Member of | The International Council for Harmonisation (ICH), a founding regulatory member with the Ministry; the International Coalition of Medicines Regulatory Authorities (ICMRA); the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since July 2014, as one authority with the Ministry. |
Don’t confuse it with: the Ministry of Health, Labour and Welfare
PMDA
The agency
- Does: the scientific review, the investigation of reports, the relief payments
- Is: an incorporated administrative agency; its staff are not civil servants
- Example: receives a 15-day report and tells the Minister what it found
MHLW
The Ministry
- Does: approves each medicine, orders revisions of the precautions, writes the Regulation
- Is: the department the Act addresses; in law the reports belong to the Minister
- Example: puts the year’s reports before the Council and orders a revision
Chapter 4
Test yourself
Myth or Truth? Pick an answer to see the explanation.
“The PMDA approves new medicines in Japan.”
Article 14 of the Act requires approval from the Minister of Health, Labour and Welfare. Article 14-2 lets the Minister have the PMDA conduct the examination; the signature stays in the Ministry.
“A serious reaction already in the package insert gets 30 days, not 15.”
Article 228-20 of the Enforcement Regulation gives predictable serious cases 30 days. Death, cases in a new active substance’s first two years and cases found through early post-marketing vigilance stay at 15.
Sources (19)
- PMDA: Who We Are
- PMDA: History
- PMDA: Message from the Chief Executive
- PMDA: Safety measures
- PMDA: International activities
- PMDA: Relief services
- PMDA: News releases
- PMDA: Profile of Services (PDF)
- PMDA: 機構の概要 (profile page, Japanese)
- Ministry of Health, Labour and Welfare: 副作用等報告の状況, report counts by fiscal year (PDF, Japanese)
- Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, Act No. 145 of 1960 (Japanese Law Translation)
- Regulation for Enforcement of the Act (Japanese Law Translation)
- MHLW Administrative Notice of 31 May 2022 on adverse reaction reporting, translated by the PMDA (PDF)
- PMDA: Pharmaceuticals and Medical Devices Safety Information No. 351, March 2018 (PDF)
- ICMRA: Membership
- PIC/S: Participating Authorities
- Food and Drug Administration (FDA): ICH overview (PDF)
- Directive 2001/83/EC, consolidated text (EUR-Lex)
- Regulation (EC) No 726/2004, consolidated text (EUR-Lex)
Last reviewed against these 19 sources. Every page is reviewed at least every six months.
