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20 BioPharm International eBook September 2019 www.biopharminternational.com Regulatory Sourcebook Pharmacopoeia Compliance Series be addressed. The articles intend to give consistent language to, and awareness of, the tasks associated with the effort and to give specific guidance to those groups and indi- viduals within a company who are charged with ensuring ongoing compliance with pharmacopoeia requirements. While focusing on the situation for innovator and generic companies, the informa- tion is also potentially helpful in bringing greater awareness and understanding to regulatory and pharmacopoeia authorities. Along with the understanding and assistance provided to those who perform this work, there is the goal of ensuring continued avail- ability of medicines with consistent quality, which comply with com- pendial and regulatory expecta- tions. Achieving compliance for t hese med ic i nes ensu res meet- ing the needs of patients around the world, regardless of where the patients live, where the medicines are manufactured, or which phar- macopoeias may apply. THE LEGAL AND REGULATORY BASIS FOR PHARMACOPOEIA COMPLIANCE Pha r macop o e ia s a re of te n re f- erenced in the laws and regula- t ion s of cou nt r ies a rou nd t he world to help ensure drug qual- it y, safet y, and eff icac y. In the United States, the Federal Food, Dr ug, and Cosmetic Act (FD&C Ac t) def i nes t he ter m "of f ic ia l compendium" as the official USP– NF or any supplement to it and the term "drug" to include articles recognized in the official USP–NF. FDA has responsibility to enforce compliance with USP–NF require- ments. In Europe, the European Union Direc tives on Medicines for Huma n a nd Veter ina r y Use (2 0 01/82/ E C a nd 2 0 01/8 3/ E C) maintain the mandatory charac- ter of European Pharmacopoeia (Ph. Eur.) monographs, which are appli- cable to all substances, prepara- tions, and pharmaceutical forms appearing in it when requesting marketing authorization. In Japan, t he L aw on S e c u r i ng Q u a l it y, Efficacy, and Safet y of Products includ ing Pha r maceut ica ls a nd Table I. Legal/regulatory basis for pharmacopoeia compliance (1). Source: World Health Organization Publication Published by Legal/regulatory basis United States Pharmacopeia and National Formulary (USP–NF) Published by the USP Convention (a private, not- for-profit organization that is independent of the US government). The USP and NF are recognized as official compendia under the Federal Food, Drug and Cosmetic Act (FD&C Act). See, for example, 501(b), 502(e)(3)(b) and others. See also USP general notices section 2.30. European Pharmacopoeia (Ph. Eur.) Published by the European Directorate for the Quality of Medicines and HealthCare (EDQM). European Union (EU) Directives 2001/82/EC and 2001/83/EC, as amended, on medicines for human and veterinary use maintain the mandatory character of European Pharmacopoeia monographs. British Pharmacopoeia (BP) Published by the British Pharmacopoeia Commission under the guidance of the Medicines and Healthcare Products Regulatory Agency (MHRA). The BP is authorized under terms of the Medicines Act 1968 (Section 99), superseded by the Human Medicines Regulations, 2012 (Section 317(1)). Japanese Pharmacopoeia (JP) Published by the Japanese government as a ministerial notification by the Ministry of Health, Labour and Welfare (MHLW). The JP is published in accordance with the Act of Securing Quality, Efficacy, and Safety of Products including Pharmaceuticals and Medical Devices, which is the most fundamental law for pharmaceutical regulation in Japan. Chinese Pharmacopoeia (ChP) Published by the Chinese Pharmacopoeia Commission of the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA). The ChP is published under laws established in 1950 by the Ministry of Health. The Drug Administrative Law issued by the National People's Congress, effective from 2001 and updated in 2015, states that the Pharmacopoeia of the People's Republic of China and the drug standards issued by the drug regulatory department under the State Council shall serve as the national drug standards. The Drug Registration regulation issued by CFDA in 2007 defines the role of ChP in drug registration. Indian Pharmacopoeia (IP) Published by the Indian Pharmacopoeia Commission on behalf of the Ministry of Health and Family Welfare of India, with oversight from the Central Drugs Standard Control Organization (CDSCO). The IP is authorized under the Indian Drugs and Cosmetics Act (1940) and Rules (1945). Russian Pharmacopoeia (SP RF) The State Pharmacopoeia of the Russian Federation (SP RF) is published by the Ministry of Health (MoH) as the authorized federal executive body. Rules of elaborating general monographs and monographs and including them in the State Pharmacopoeia were enacted by Federal Law No. 61-FZ on Circulation of Medicines (2010).