Koseisho definition

Koseisho means the Japanese Ministry of Health and Welfare, or any successor agency thereto.
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Koseisho as used herein means the Ministry of Health and Welfare of Japan.
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Koseisho. 1.27 “Licensed Territory”
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Examples of Koseisho in a sentence

  • If requested by Vertex, CFFT will arrange for one or more representatives of CFFT to participate in meetings between representatives of Vertex and any of the FDA, the EMEA and Koseisho (MHW Japan), to the extent that Vertex reasonably believes that representatives from CFFT would further the regulatory approval process.

  • The Japanese drug regulatory body is known as the Ministry of Health, Labor and Welfare (MHLW), or the Koseisho.

  • NDD will assist CMS with any application for regulatory approval whether from the FDA or any other regulatory body (e.g., 510(K), PMA, Koseisho), country product registration and OSHA/safety related requests.

  • Thedeveloper of Corebot simply stopped supporting it and as for Vawtrak, its author was arrested, which resulted in this activity being stopped.But they have been replaced by new Trojans: Trickbot, Sphinx 2, TinyNuke, Portal, GNAEUS, and Plan2016.

  • Upon CMS's reasonable request, SMSI shall reasonably cooperate as necessary with, and provide appropriate Oxygen Sensor data and information to, CMS regarding the Oxygen Sensors that would assist in, among other items, any application for regulatory approval whether from the FDA or any other regulatory body (e.g., 510(K), PMA, Koseisho), country product registration and OSHA/safety related requests.

  • Techniclone will conduct a stability program for Antibody and Product, including Packaged Product, to be produced pursuant to this Article VII (in compliance with pharmaceutical industry standards and requirements of the FDA, EMEA and Koseisho) and agreed upon between the Parties.

  • If, on the date occurring at the end of five (5) years from the Effective Date, PanGenetics has not filed an IND or equivalent submission related to Licensed Products with either the Japanese Koseisho, or a corresponding regulatory agency in the United Kingdom, Germany, France or other major market country in the European Community, Chiron shall have the right to determine whether PanGenetics has made diligent efforts to produce Licensed Products.

  • The Company has never been the subject of any inspection or investigation by a French or foreign regulatory authority and has never received any notice of deficiency by any regulatory authority (including but not limited to the French Ministry of Health, the Federal United States Food And Drug Administration, and the Japanese Ministry of Health ("Koseisho").

  • Techniclone shall be responsible for all testing and document generation (including without limitation all facilities information and related documentation; chemistry, manufacturing, and control information; regulatory methods and controls; and assays and reference standards) necessary for and required by the FDA, EMEA or Koseisho for the manufacture of Antibody and Product, including Packaged Product.

  • The Company is authorized to sell Neuromate product in the European Community, Japan and the United States and holds all regulatory authorizations to this effect under its own name, save for the regulatory authorization of Koseisho which has been granted to the exclusive distributor of the Company in Japan, IMATRON.


More Definitions of Koseisho

Koseisho means the Japanese governmental agency responsible for the review and approval of therapeutic or diagnostic products intended for human use or its successor.
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Related to Koseisho

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency or any successor entity thereto.

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Health Canada means the department of the Canadian Government known as Health Canada and includes, among other relevant branches, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;

  • tpd means tonnes per day.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • securities regulatory authority or “SRA” means a body created by statute in any Canadian or foreign jurisdiction to administer securities law, regulation and policy (e.g. securities commission), but does not include an exchange or other self regulatory entity;

  • EMEA means the European Medicines Agency.

  • EMA means the European Medicines Agency or any successor agency thereto.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • orphan means a child who has no surviving parent caring for him or her;

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • PHSA means the Public Health Service Act (or any successor thereto), as amended from time to time, and the rules, regulations, guidelines, guidance documents and compliance policy guides issued or promulgated thereunder.

  • DEA means the Drug Enforcement Administration of the United States of America, any comparable state or local Governmental Authority, any comparable Governmental Authority in any non-United States jurisdiction, and any successor agency of any of the foregoing.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Canadian Securities Regulatory Authorities means the securities regulatory authorities in each of the provinces and territories of Canada;

  • MAA means a Marketing Authorization Application, in relation to any Product, filed or to be filed with the EMA (or equivalent national agency), for authorization to place a medicinal product on the market in the European Union (or any other territory).

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.