science

Pharmaceuticals and Medical Devices Agency

Pharmaceuticals and Medical Devices Agency is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Pharmaceuticals and Medical Devices Agency rather than just read about it. In short: The Pharmaceuticals and Medical Devices Agency (独立行政法人医薬品医療機器総合機構) (PMDA) is a Japanese corporation, an Independent Administrative Institution, responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. It is similar in function, in many respects, to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the Un…

Key takeaways

Pharmaceuticals and Medical Devices Agency belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Pharmaceuticals and Medical Devices Agency to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Pharmaceuticals and Medical Devices Agency from memory before moving on to harder problems.

Reference excerpt

The Pharmaceuticals and Medical Devices Agency (独立行政法人医薬品医療機器総合機構) (PMDA) is a Japanese corporation, an Independent Administrative Institution, responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. It is similar in function, in many respects, to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Spanish Agency of Medicines and Medical Devices in Spain or the Food and Drug Administration in the Philippines. The PMDA adopted the International Council for Harmonisation (ICH) Electronic Common Technical Document (eCTD) format for electronic regulatory submissions beginning in 2017.

Tasks

Among other things, the agency is tasked with the following:

Drug and medical device testing: Scientific review of market authorization applications based on Japanese pharmaceutical law Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA)) Inspection and conformity assessment of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Practice Systems and Programs (GPSP) Auditing of manufacturers to ensure they conform to Good Manufacturing Practice (GMP) and have a suitable Quality Management System (QMS) Post-marketing drug safety: The collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices Advising consumers on approved products Research on the development of industry standards Victim compensation: Payment of medical costs, lost wages, and pain and suffering for those who experience injury or disability resulting from the use of medical products Disbursement of funds to those infected with HIV as a result of blood transfusions

Leadership Yasuhiro Fujiwara, former head of the National Cancer Center Japan, became chief executive of the agency in April 2019. From 2008 to 2019, the chief executive of the agency was Tatsuya Kondo, a neurosurgeon and graduate of the University of Tokyo.

References

Further reading Nagasaka, Satoru; Lang, Benjamin; Shintani, Mihoko & Ueno, Sayaka (April 2008). "An Overview of Pharmaceutical and Medical Device Regulation in Japan" (PDF). Asian Counsel. Philadelphia, PA: Morgan Lewis-TMI: 28–31. Archived from the original (PDF) on 11 February 2014. Retrieved 30 September 2012. Morgan Lewis-TMI is a joint venture between Morgan, Lewis & Bockius LLP and TMI Associates [Tokyo, Japan].{{cite journal}}: CS1 maint: multiple names: authors list (link)

External links Official website

Illustrations

Worked examples

Example 1 — a first encounter with Pharmaceuticals and Medical Devices Agency

Start with the simplest possible case. Write down what Pharmaceuticals and Medical Devices Agency claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Pharmaceuticals and Medical Devices Agency before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Pharmaceuticals and Medical Devices Agency ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Pharmaceuticals and Medical Devices Agency

In research: Pharmaceuticals and Medical Devices Agency appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Pharmaceuticals and Medical Devices Agency in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Pharmaceuticals and Medical Devices Agency is common in secondary-school and first-year university syllabi. It links to neighbouring topics 2004 establishments in Japan, Government agencies established in 2004, Independent Administrative Institutions of Japan, so understanding it makes those chapters shorter.
In everyday life: Look for Pharmaceuticals and Medical Devices Agency outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Pharmaceuticals and Medical Devices Agency in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Pharmaceuticals and Medical Devices Agency means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Pharmaceuticals and Medical Devices Agency out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Pharmaceuticals and Medical Devices Agency in simple terms?

Why does Pharmaceuticals and Medical Devices Agency matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Pharmaceuticals and Medical Devices Agency?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Pharmaceuticals and Medical Devices Agency.