Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 29 of 54

30 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m takeaway message is clear; companies must comply with compendial requirements and must also remain up to date with changes made to the requirements. This ongoing re- vision to the pharmacopoeias around the world poses one of the main challenges for companies and will be further addressed in later articles in this series. Purpose and content of pharmacopoeias Having highlighted the need to comply with compendial requirements, with examples of obser vations resulting from non-compliance, it is helpful to have an overall un- derstanding of the role pharmacopoeias play to support the availability of medicines. This understanding may be found in the histor y, purpose, and content of phar- macopoeias. Many of the pharmacopoeias from around the world have met during the past several years, under the guidance of WHO, to discuss collaboration and har- monization in today's globalized compendial, regulatory, and supply situation for drugs. The main suggestion to come out of these meetings was the development of Good Pharmacopoeial Practices (GPhP) recently published by WHO (4). WHO's GPhP states, "The primar y objective of t he GPhP guidance is to def ine approaches and policies in establishing pharmacopoeial standards with the ultimate goal of harmonization" (4). This focus on compendial har- monization is ref lected in the origins of several of the pharmacopoeias (to be detailed in another article in this series) and is critical to the ongoing goal of providing medicines with consistent quality to patients around the world. The WHO document goes on to list the purpose and role of the pharmacopoeias: "A pharmacopoeia's core mission is to protect public health by creating and making 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). Pharmacopoeia Compliance Series

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