The (PhMDA) is an

Independent Administrative Institution An Incorporated Administrative Agency (独立行政法人, ''Dokuritsu gyōsei hōjin'' or ''Dokugyo'' in abbreviation) is a type of legal corporation formulated by the Government of Japan under the Act on General Rules for Incorporated Administrat ...

responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in

Japan Japan ( ja, 日本, or , and formally , ''Nihonkoku'') is an island country in East Asia. It is situated in the northwest Pacific Ocean, and is bordered on the west by the Sea of Japan, while extending from the Sea of Okhotsk in the n ...

. It is similar in function to the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

in the United States, the

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptab ...

in the United Kingdom or the

in the Philippines. The PhMDA has been eCTD compliant at least since December 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 Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements ...

(GCP), Good Laboratory Practice (GLP), and

Good Practice Systems and Programs In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

(GPSP) ** Auditing of manufacturers to ensure they conform to

Good Manufacturing Practice Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceut ...

(GMP) and have a suitable

Quality Management System A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). I ...

(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 transfusion Blood transfusion is the process of transferring blood products into a person's circulation intravenously. Transfusions are used for various medical conditions to replace lost components of the blood. Early transfusions used whole blood, but mo ...

Leadership

The chief executive of the agency is Yasuhiro Fujiwara, former head of the National Cancer Center Japan. From 2008 to 2018, the chief executive of the agency was Tatsuya Kondo, a neurosurgeon and graduate of the University of Tokyo.

References

External links

* {{authority control Medical and health organizations based in Japan National agencies for drug regulation Independent Administrative Institutions of Japan Government agencies established in 2004 2004 establishments in Japan