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The Japanese Pharmacopoeia 2015 (JP-15)


Japanese Pharmacopoeia (JP-15) Fifteen Edition

The Japanese Pharmacopoeia (JP) is an official document that defines specifications, standards and standard test methods needed to ensure the quality of medicines in Japan.

Paragraph 2 of Section 41 of the Act on Assurance of Quality, Efficacy and Safety of Products, Including Medicines and Medical Devices, states that a full evaluation of JP must be done at least once every 10 years. Since version 9 of JP, a major overhaul is carried out every 5 years. In addition to full revisions, a supplement has been published twice every 5 years since the 12th edition of the JP and minor revisions have been made as necessary to take into account recent advances in science in favor of international coordination.

JP's 16th edition was released by Notice No. 65 from the Ministry of Health, Labor and Welfare (MHLW) on March 24, 2011.

Japanese Pharmacopoeia Commission

In July 2011, the Committee on JP established the basic principles for the preparation of the JP 15th Edition, setting out the roles and characteristics of the JP, the definite measures for the revision, and the date of the revision.

At the Committee, the five basic principles of JP, whichwerefer to as the``five pillars'', were established as follows: 1) Including all drugs which are im-portant from the viewpoint of health care and medical treatment; 2) Making qualitative improvement by introducing the latest science and technology; 3) Promoting internationalization; 4) Making prompt partial revision as necessary and facilitating smooth administrative operation; and 5) Ensuring transparency regarding the revision, and disseminating the JP to the public. It was agreed that the Committee on JP should make efforts, on the basis of these principles, to ensure that the JP is used more effectively in the fields of health care and medical treatment by taking appropriate measurements, including getting the understanding and cooperation of other parties concerned.

Japanese Pharmacopoeia Standard

It was agreed that the JP should provide an official standard, being required to assure the quality of medicines in Japan in response to the progress of science and technology and medical demands at the time. It should define the standards for specifications, as well as the methods of testing to assure overall quality of all drugs in principle, and it should have a role in clarifying the criteria for quality assurance of drugs that are recognized to be essential for public health and medical treatment. JP has been prepared using the knowledge and experience of several pharmaceutical professionals. Therefore, the PC should have the characteristics of an official standard, which can be widely used by all parties concerned, and play an appropriate role in providing information and understanding of drug quality to the public. Furthermore, as a quality standard for pharmaceutical drugs, it should help promote and sustain progress, as well as international consistency and harmonization of technical requirements within the international community. It was also agreed that CP articles should address drugs that are important from the perspective of health care and medical treatment, clinical performance or benefit and frequency of use as soon as possible after they come to market. 

JP Expert Committees were originally organized with the following committees: Expert Committee; Sub-expert Committee; Committee on Chemicals; Committee on Antibiotics; Committee on Biologicals; Committee on Crude Drugs; Committee on Pharmaceutical Excipients; Committee on Physico-Chemical Methods; Committee on Drug Formulation; Committee on Physical Methods; Committee on Biological Methods; Committee on Nomenclature for Pharmaceuticals; Committee on International Harmonization; Committee on Pharmaceutical Water and Committee on JP Reference Standards. Furthermore, working groups were established under the Committee on Physico-Chemical Methods; Committee on Drug For-mulation and Committee on Biological Methods to expedite discussion on revision drafts. Later, the Ex-pert Committees were reorganized in order to solve technical issues with preparation of JP drafts; the Sub-committee on Manufacturing Process-related Matters was newly established and the Committee on JP Refer-ence Standards was re-formed and renamed Com-mittee on Reference Standards. Moreover, working groups were established under the Committee on Phar-maceutical Excipients and Committee on International Harmonization.

In accordance with the above principles, the com-mittees initiated deliberations on selection of articles and on revisions for General Notices, General Rules for Crude Drugs, General Rules for Preparations,General Tests, Monographs and so on.

In order to ensure distribution of drugs in the area hit by the 2011 off the Pacific coast of Tohoku Ear-thquake on March 11, 2011, for those drugs that were distributed by the distributors in the same quake-hit area, the expiry date of interim measure of the Supple-ment II to the JP 15th Edition under the Ministerial Notification No. 425 of the MHLW dated September 30, 2009 was extended to June 30, 2013 and that of the Partial Revision of the JP 15th Edition under the Ministerial Notification No. 322 of the MHLW dated July 30, 2010 was extended to January 31, 2012, which was promulgated as the partial revision of the pream-ble of the Ministerial Notification of the JP 16th Edi-tion by Ministerial Notification No. 96 of the MHLW on March 31, 2011, and became effective.

Draft revisions covering subjects in General Notices, General Rules for Crude Drugs, General Rules for Preparations, General Tests and Monographs, for which discussions were finished between April 2010 and March 2012, were prepared for a supplement to the JP 16. They were examined by the Committee on JP in May 2012, followed by the Pharmaceutical Af-fairs and Food Sanitation Council (PAFSC) in June 2012, and then submitted to the Minister of Health, Labour and Welfare.

The supplement was named ``Supplement I to the JP 16th Edition'', promulgated on September 27, 2012 by Ministerial Notification No. 519 of MHLW, and became effective on October 1, 2012.

Numbers of discussions in the committees to pre-pare the supplement drafts were as follows: Expert Committee (8); Sub-expert Committee (4), Committee on Chemicals (22), Committee on Antibiotics (5); Committee on Biologicals (9); Committee on Crude Drugs (21); Committee on Pharmaceutical Excipients (12); Committee on Physico-Chemical Methods (14); Committee on Drug Formulation (19); Committee on Physical Methods (7); Committee on Biological Methods (13); Committee on Nomenclature for Phar-maceuticals (7); Committee on International Harmoni-zation (8); and Committee on Pharmaceutical Water (7).

It should be noted that in the preparation of the drafts for the supplement, generous cooperation was given by the Pharmaceutical Technology Committee of the Osaka Pharmaceutical Manufacturers Association, the Pharmacopeia and CMC Committee of the Pharmaceutical Manufacturers' Association of Tokyo, the Tokyo Crude Drugs Association, the International Pharmaceutical Excipients Council Japan, the Japan Kampo Medicines Manufacturers Association, the Japan Flavor and Fragrance Materials Association, the Japan Medicinal Plant Federation, the Japan Pharmaceutical Manufacturers Association, the Parenteral Drug Association Japan Chapter, the XVII

Japan Reagent Association, the Japan Oilseed Processors Association, the Home Medicine Association of Japan, and the Association of Membrane Separation Technology of Japan.

In consequence of this revision, the JP 16th Edition carries 1837 articles, owing to the addition of 77 articles and the deletion of 4 articles.

Draft revisions covering subjects, the revision of the General Tests and the revision of the specification of monograph Gelatin connected with the harmonization among the three pharmacopeias, JP, EP and USP were examined by the Committee on JP in February 2013, followed by PAFSC in April 2013, and then submitted to the Minister of Health, Labour and Welfare.

This revision was promulgated on May 31, 2013 by Ministerial Notification No. 190 of MHLW, and became effective.

Draft revisions covering subjects in General Notices, General Rules for Crude Drugs, General Rules for Preparations, General Tests, and Monographs, for which discussions were finished between April 2012 and September 2013, were prepared for a supplement to the JP 16. They were examined by the Committee on JP in October 2013, followed by the PAFSC in December 2013, and then submitted to the Minister of Health, Labour, and Welfare.

The supplement was named ``Supplement II to the JP 16th Edition'' and promulgated on February 28, 2014 by Ministerial Notification No. 47 of MHLW, and became effective.

The numbers of discussions in the committees to pre-pare the supplement drafts were as follows: Expert Committee (5); Sub-committee on Manufacturing Process-related Matters (6); Committee on Chemicals (16); Committee on Antibiotics (3); Committee on Biologicals (8); Committee on Crude Drugs (16); Com-mittee on Pharmaceutical Excipients (12); Committee on Physico-Chemical Methods (9); Committee on Drug Formulation (14); Committee on Biological Methods (13); Committee on Nomenclature for Pharmaceuticals (4); Committee on International Harmonization (10); and Committee on Reference Standards (1).

It should be noted that in the preparation of the drafts for the supplement, generous cooperation was given by the Pharmaceutical Technology Committee of the Osaka Pharmacy.

nautical Manufacturers Association, the Pharmacopeia and CMC Committee of the Pharmaceutic