Japanese Pharmacopeia
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Japanese Pharmacopeia
The is the official pharmacopoeia of Japan. It is published by the . The first edition was published on 25 June 1886, with revisions being issued from time to time. The current revision is number 18, issued electronically on 7 June 2021. An official English translation is in preparation (status: 06 Aug 2021). See also * ''The International Pharmacopoeia ''The International Pharmacopoeia'' (''Pharmacopoeia Internationalis'', ''Ph. Int.'') is a pharmacopoeia issued by the World Health Organization as a recommendation, with the aim to provide international quality specifications for pharmaceutical s ...'' References Pharmacopoeias Pharmacy in Japan {{japan-lit-stub ja:薬局方#日本薬局方 ...
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Pharmacopoeia
A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography ''pharmacopœia'', meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. Descriptions of preparations are called monographs. In a broader sense it is a reference work for pharmaceutical drug specifications. Etymology The term derives from grc, φαρμακοποιία ''pharmakopoiia'' "making of (healing) medicine, drug-making", a compound of φάρμακον ''pharmakon'' "healing medicine, drug, poison", the verb ποιεῖν ''poiein'' "to make" and the abstract noun suffix -ία ''-ia''. In early modern editions of Latin texts, the Greek diphthong οι (''oi'') is latinized to its Latin equivalent ''oe'' which is in turn written with the ligature ''œ'', giving the spelling ''pharmacopœia''; in modern UK English, ''œ'' is wri ...
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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 toward the East China Sea, Philippine Sea, and Taiwan in the south. Japan is a part of the Ring of Fire, and spans Japanese archipelago, an archipelago of List of islands of Japan, 6852 islands covering ; the five main islands are Hokkaido, Honshu (the "mainland"), Shikoku, Kyushu, and Okinawa Island, Okinawa. Tokyo is the Capital of Japan, nation's capital and largest city, followed by Yokohama, Osaka, Nagoya, Sapporo, Fukuoka, Kobe, and Kyoto. Japan is the List of countries and dependencies by population, eleventh most populous country in the world, as well as one of the List of countries and dependencies by population density, most densely populated and Urbanization by country, urbanized. About three-fourths of Geography of Japan, the c ...
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Pharmaceuticals And Medical Devices Agency
The (PhMDA) is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. It is similar in function to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom or the Food and Drug Administration 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 (GCP), Good Laboratory Practice (GLP), and Good Practice Systems and Programs (GPSP) ** Auditing of manufacturers to ensure they conform to Good Manufacturin ...
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The International Pharmacopoeia
''The International Pharmacopoeia'' (''Pharmacopoeia Internationalis'', ''Ph. Int.'') is a pharmacopoeia issued by the World Health Organization as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms, together with supporting general methods of analysis, for global use. Its texts can be used or adapted by any WHO member state wishing to establish legal pharmaceutical requirements. The ''Ph.Int.'' is based primarily on medicines included in the current WHO Model List of Essential Medicines (EML) and medicines included in the current invitations to manufacturers to submit an expression of interest (EOI) to the WHO Prequalification Team – Medicines (PQT) and those of interest to other UN Organizations. In recent years, priority has been given to medicines of importance in low and middle income countries, which may not appear in any other pharmacopoeias, including child-frien ...
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Pharmacopoeias
A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography ''pharmacopœia'', meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. Descriptions of preparations are called monographs. In a broader sense it is a reference work for pharmaceutical drug specifications. Etymology The term derives from grc, φαρμακοποιία ''pharmakopoiia'' "making of (healing) medicine, drug-making", a compound of φάρμακον ''pharmakon'' "healing medicine, drug, poison", the verb ποιεῖν ''poiein'' "to make" and the abstract noun suffix -ία ''-ia''. In early modern editions of Latin texts, the Greek diphthong οι (''oi'') is latinized to its Latin equivalent ''oe'' which is in turn written with the ligature ''œ'', giving the spelling ''pharmacopœia''; in modern UK English, ''œ'' is wr ...
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Pharmacy In Japan
Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links health sciences with pharmaceutical sciences and natural sciences. The professional practice is becoming more clinically oriented as most of the drugs are now manufactured by pharmaceutical industries. Based on the setting, pharmacy practice is either classified as community or institutional pharmacy. Providing direct patient care in the community of institutional pharmacies is considered clinical pharmacy. The scope of pharmacy practice includes more traditional roles such as compounding and dispensing of medications. It also includes more modern services related to health care including clinical services, reviewing medications for safety and efficacy, and providing drug information. Pharmacists, therefore, are experts on drug therapy and ...
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