INSTITUTION PROFILE
PMDA
— Japan’s specialist agency for reviewing the scientific substance of new drug applications
PMDA is an independent administrative corporation that is administered by the Ministry of Health, Labour and Welfare. RolesScience to examine the application of new drugs and advise the company from the middle of developmentComment The approval itself is not PMDAMinister of Health, Labour and WelfareComment In recent years, measures to "drug loss" which is not developed in Japan are also the pillar of business. In this article, PMDAHow much does drug discovery and DDS affect?Squeeze and organize.
- PMDA in 30 seconds
- What kind of organization is the type of influence?
- What is DDS?
- Scope of influence (authorization and region)
- Companies and organizations involved
- Future Prospects
- Glossary/Source/Ins ment and Source Response Table
1. PMDA in 30 seconds
Medical DevicesMedical Devices
Approval of new drugs in Japan2 stepsComment After reviewing PMDA and deliberation or reporting at the Pharmaceutical Council,Minister of Health, Labour and Welfare ApprovedHome FactsHome The Ministry of Health, Labour and Welfare decides whether to prioritize drugs other than rare diseases. FactsHome PMDA is not a “determining organization”How to read the contents of the application and tell the company where it is not enoughIn order to carry it in one hand, It is the first and largest partner for companies who want to give medicine in Japan.
2. What kind of organization is the type of influence?
The drug discovery and DDS articles will not make medicines yourself, unlike companies. instead ofWhat pathways will affect the industry?is divided into four types.
3. What is DDS?
| Activities | Home | Numbers and Examples (Announcement of PMDA) |
|---|---|---|
| New Drug Review | Evaluate and approve quality, effectiveness and safety. Minister of Health, Labour and Welfare | List of approved products for 2025140 foundedHome 44 new active ingredients (listed) The calculation of this paper） |
| Goal of the examination period | Manage the total examination period from application to approval to 80% of items within this period | FY2025Priority items 9.0 months9 months11.7 months(12 months) 30.0% of priority items for approval |
| Clinical Trial Consultation | Before applying, consult with the company to determine whether the evaluation items and test methods are sufficient. Advice for a venture company from the development program | There is a framework such as RS general consultation and RS strategy consultation |
| Pioneering Pharmaceutical Designation System | A system to prepare innovative new drugs and accelerate the examination (formerly the predetermined examination designation system) | The goal of the total examination period is6 monthsHome FY2024 Results 4.8 Months and FY2025 No Approved Items |
| Consultation for children and rare diseases | On July 1, 2024, we commenced consultation on the priority examination of rare disease medicines as a business of 'Pharmaceuticals for the treatment of diseases and rare diseases' | Rare disease drugs specified in FY2025101 Items |
modalities seen for 2025 approval
List of approved items for new drugs, not only new active ingredients, but also existing drugsAdding efficacyAlso included. The following classification is written from the component name (Delxecan-Bedtin-ADC, ~silane-siRNA, mRNA) The calculation of this paper。
| modalities | Company name | Approval date and category |
|---|---|---|
| ADC | Em Hearts / Polibee | August 25, 2025, March 23, 2026, March 23, 2026 |
| siRNA | Alnylam Japan | June 24, 2025 |
| mRNA | Mezvia (Modelna Japan). RS virus infection prevention | May 19, 2025 |
| Contains peptides | Nobo Nordic Pharma Insulin Contains Ikodek and Semaglutinide | February 19, 2026 |
PMDA's business results report is a future issue"Drug loss" for overseas venture companiesHome FactsHome The Washington D.C. office opened on November 1, 2024. FY202518 consultations from companies not based in Japan7 of our interviews have led to consultation with the team in charge FactsHome Because many of the new modalities are born from emerging companies in the United States,In the first stage, let's send candidates to apply for JapanIt is the center of measures.
4. Scope of influence (authorization and region)
| What PMDA has | Not having | |
|---|---|---|
| New DrugsResearch on the reliability of the application materials, research on the global environment (such as GMP/GCTP), and consultation on clinical trials | Decision of approval (Minister of Health, Labour and Welfare), Designation of rare disease drugs (Minister of Health, Labour and Welfare), Decision of priority examination other than rare disease (Ministry of Health, Labour and Welfare) | |
| Region | Japanese marketHome Applicants are eligible to sell in Japan for any country | Authorization to determine the availability of sales in other countries |
| Working overseas | Asia Office (Thailand, July 2024) and Washington D.C. Office (November 2024). Regulatory cooperation with U.S. government agencies and information transmission to U.S. startups | Permission to apply for overseas companies in Japan (information and consultation) |
| International Location | ICHRegulatory member at the time of establishment(MHLW/PMDA, Japan) In collaboration with the Ministry of Health, Labour and Welfare, we received WHO Listed Authority certification in pharmaceutical field | Permissions to decide the ICH guideline alone (depending on the agreement of the member authority) |
1,053 peopleWhole PMDA including medical devices, regenerative medicine products, and health reliefNumber of employees Total number of 656 people including medical devices FactsHome The number and amount of people engaged only in the examination of new drugs is not listed in the business results report Undetermined / FutureHome In addition, 140 approved items include new efficacy and new doses, which are different from the FDA’s number of “novel drugs”.
5. Companies and organizations involved
6. Future Prospects
| Read | Primary Information | |
|---|---|---|
| Washington D.C. OfficeWorking with U.S. companieswill be the center of the future drug loss measures | Our business results report cooperates with overseas companies to take outreach measures against drug loss. | |
| ADC and siRNA are more than approved by new ingredientsAdding effect of existing productsis the center of the number | In the list of FY2025, both ADC and siRNA items are approved as new efficacy (mRNA vac、s are new active ingredients) | |
| How much drug loss is solved (Change in number of drugs not developed in Japan) | There is a number of consultations in the business results report, but there is no indicator showing the degree of resolution. | Undetermined / Future |
7. Glossary
- Corporate Governance
- Businesses in Japan Conducting operations under the supervision of the ministers of the main office.
- Total screening period (80% tiles)
- The period from application to approval is arranged in a short order, and the period of 80% of items will be charged. Indicators of PMDA screening goals.
- Clinical Trial Consultation
- Before applying for approval, it is a mechanism to consult with PMDA whether the test plan and evaluation item meet the requirements of approval.
- Ross
- Drugs used overseas are not developed or applied in Japan.
- Rare Disease Drugs
- Pharmaceuticals designated by the Minister of Health, Labour and Welfare to meet the requirements of less than 50,000 patients in Japan. Prioritized screening.
8. Source
- PMDA What is PMDA (name, establishment, type of corporation, integration of three organizations) https://www.pmda.go.jp/about-pmda/outline/0001.html
- PMDA In May 2025, we will cooperate with the Ministry of Health, Labour and Welfare, the Ministry of Health, Labour and Welfare, advice for clinical trial consultation and a venture, the establishment and role of the Asian office and Washington D.C. office. https://www.pmda.go.jp/files/000219906.pdf
- PMDA Business Results Report (FY2019). Address, number of employees, budget, number of employees, total examination period of new drugs, priority item registration, pioneering pharmaceutical designation system, medical consultation center for diseases and rare diseases, designated number of rare disease drugs, consultation number of Washington D.C. office, drug loss counter, WHO Listed Authority https://www.pmda.go.jp/files/000282524.pdf
- PMDA List of approved items for new drugs (FY2025). PMDA examination and pharmacy council approval by the Minister of Health, Labour and Welfare, description of priority screening and rare disease drugs. https://www.pmda.go.jp/review-services/drug-reviews/review-information/p-drugs/0039.html
- PMDA List of approved items (New Drugs: April 2025 - March 2026) Approval date, company name, ingredient name, classification per item. https://www.pmda.go.jp/files/000277966.xlsx
- ICH Members & Ob。s (Regulators at the time of establishment: EC, Europe/FDA, United States/MHLW/PMDA, Japan) https://www.ich.org/page/members-observers
9. Response table of claims and sources
| Content | ||
|---|---|---|
| Formal name, established on April 1, 2004, merged with three organizations, type of corporation | Facts | Source 1 https://www.pmda.go.jp/about-pmda/outline/0001.html |
| Advice for the Ministry of Health, Labour and Welfare, Clinical Trial Consultation and A venture, Time and Role of Overseas Offices | Facts | Source 2 https://www.pmda.go.jp/files/000219906.pdf |
| Address, 1,053 employees, 656 employees, 9.0 months, 11.7 months, priority 30.0%, pioneering drug designation system, consultation center, 101 rare disease medicines, 18 and 7 consultations at Washington D.C. office, drug loss measures, WHO Listed Authority | Facts | Source 3 https://www.pmda.go.jp/files/000282524.pdf |
| The Ministry of Health, Labour and Welfare approved by the Minister of Health, Labour and Welfare after the examination of PMDA and the pharmacy council, and priority examination other than rare diseases is determined by the Ministry of Health, Labour and Welfare. | Facts | Source 4 https://www.pmda.go.jp/review-services/drug-reviews/review-information/p-drugs/0039.html |
| Company name, approval date, classification of Enharts, Polibby, Amvtra, Melsbia, and Quens | Facts | Source 5 https://www.pmda.go.jp/files/000277966.xlsx |
| MHLW/PMDA is a member of regulatory authorities at the time of establishment of ICH | Facts | Source 6 https://www.ich.org/page/members-observers |
| List of 140 FY2025, including 44 new active ingredients, classification of modalities by ingredient names | The calculation of this paper | List of Source 5 |
| Engine Four Mold Segment | The calculation of this paper | Advice for the Ministry of Health, Labour and Welfare, Clinical Trial Consultation and A venture, Time and Role of Overseas Offices |
| Number of people and amounts engaged only in the examination of new drugs | Undetermined / Future | Not specified in Source 3. This article does not estimate |
| Chapter 6 Prospects ()ulation 2 Items / Undetermined 1 Items) | Interpre of this paper from the description of source 3 and 5 |
Last Updated:September 26, 2026/Troy Technical
This document is based on the official website of PMDA, business information, business results report, approval item list, and ICH's official website. This is an interpretation that reads from primary information. This article does not recommend certain medicines.