PMDA Philosophy

Structure of PMDA Philosophy

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PMDA’s Principle

PMDA continues to improve the public health and safety of our nation by reviewing applications for marketing approval of pharmaceuticals and medical devices, conducting safety measures, and providing relief to people who have suffered from adverse drug reactions.

We conduct our mission in accordance with the following principles:

• We pursue the development of medical science while performing our duty with greater transparency based on our mission to protect public health and the lives of our citizens.
• We will be the bridge between the patients and their wishes for faster access to safer and more effective drugs and medical devices.
• We make science-based judgments on quality, safety, and efficacy of medical products by training personnel to have the latest technical knowledge and wisdom in their field of expertise.
• We play an active role within the international community by promoting international harmonization.
• We conduct services in a way that is trusted by the public based on our experiences from the past.

PMDA’s Purpose

The environment surrounding pharmaceuticals, medical devices and regenerative medicines is changing every day.
In order to respond flexibly to these changes, the Purpose reflects our wish to mature ourselves further and to create a world where everyone can feel peaceful and can lead vibrant and healthy lives, together with all stakeholders.
Each and every PMDA member works with the Purpose and continues to create "Tomorrow's Normal" together with everyone around the world.
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PMDA’s Values

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PMDA Code of Conduct（Code of Ethics）

We conduct our operations with social ethics and values of regulatory science in accordance with the following Code of Conduct in order to put the PMDA philosophy into practice. 

1. Compliance

   We comply with laws and regulations, and act with the highest ethical standards in accordance with social norms. 

2. Strict Information Management

   We strictly manage confidential information, including trade secrets and personal information, which we obtain in the course of our operations.

3. Ensure Fairness in the Performance of our duties

   We act up to “Honest PMDA” based on high transparency, fairness, sincerity, courtesy, and humility to all stakeholders involved in our operations.

4. Enhance the Work Environment

   We create a positive work environment and maintain good communications including greetings.

5. Health Management

   We maintain and manage our own health and are mindful of the health of people around us.

6. Prevention of harassment

   We respect the dignity and personality of each individual, and we do not tolerate any form of discrimination or harassment.

7. Teamwork

   We report, communicate, and consult in a timely and appropriate manner, understand others’ standpoint, listen sincerely to other people’s views, and cooperate in our operations.

8. Enhance of our operations

   We constantly improve our operations, increase efficiency, and aim for higher goals with a positive spirit.

9. Proper Management and Use of PMDA Assets

   We manage the assets owned by the PMDA so that they are always in a good condition and use them efficiently without mixing public and personal matters.

4F

We promote “4Fs (First)” listed below to put the PMDA Philosophy into practice: 

Patient First

We make well communication with healthcare professional and work giving the highest priority to patient satisfaction.

Access First

We accelerate the access to innovative medical products of public demand, while ensuring appropriate risk-benefit balance.

Safety First

Focusing on risk mitigation, we implement efficient post-marketing data collection and product distribution control, especially for accelerated approval schemes such as “Conditional Early Approval System” and “SAKIGAKE Designation System”.

Asia First

We promote regulatory harmonization and improve public health among Asian countries/regions, as well as build trust in Japanese regulatory system.