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 north ...

. It is similar in function to the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

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 acceptably ...

in the United Kingdom or the

in the Philippines. The PhMDA has been

eCTD The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format a ...

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 In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, ...

(GLP), and Good Practice Systems and Programs (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, pharmaceutica ...

(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 The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...

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