A Brief History of Pharmacopoeias: a Global Perspective
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Pharmacopoeia Compliance Series A Brief History of Pharmacopoeias: A Global Perspective J. Mark Wiggins and Joseph A. Albanese he global and historical perspective presented herein is critical to understanding the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias, as well as providing a Tdeeper appreciation of the important harmonization prog- ress achieved to date. Also, by understanding the lack of iQoncept/stock.adobe.com harmonization, the reader will appreciate the complexity it adds to a company’s processes for compendial monitoring In this series of articles, the authors provide an understanding and compliance. about the need for pharmacopoeia compliance. The following articles can be found within this ebook and online Pharmacopoeias–A global perspective and brief history at www.PharmTech.com/compendia: According to the latest index compiled by the World Health • Why Pharmacopoeia Compliance is Necessary Organization (WHO) (1), there are as many as 40 pharma- • Why Pharmacopoeia Compliance is Difficult copoeias published around the world, with as many as 60 • A Brief History of Pharmacopoeias: A Global Perspective active pharmacopoeia commissions who carry out the work • Global Pharmacopoeia Standards: Why Harmonization of developing and maintaining these pharmacopoeias (Table is Needed I). To better understand the situation today, it is instructive • Harmonization Efforts by Pharmacopoeias and to consider the history of pharmacopoeias. A timeline is Regulatory Agencies provided in Figure 1 indicating the year when many of the Upcoming articles in this series will include the following: pharmacopoeias were created. Although the earliest work • Revision Process for Global/National Pharmacopoeias presenting medical knowledge and herbal remedies may • Surveillance Process for Industry: Monitoring date back more than 3000 years to ancient Egypt (2), it Pharmacopoeia Revisions was De Materia Medica, which appeared in the 1st century • Monograph Development: Why and When to Participate CE in Greece and Rome that perhaps represents the first • Monograph Development: How to Participate; How to example of a “pharmacopoeia” (3). (The word “pharmaco- Harmonize poeia” translates from the ancient Greek as “drug-making”.) • A Practical Approach to Pharmacopoeia Compliance This treatise on medical matters compiled herbal remedies • A Case Study in Pharmacopoeia Compliance: Excipients known at the time, along with their methods of preparation. and Raw Materials Beginning in the 16th century, several pharmacopoeias con- • Pharmacopoeia Compliance: Putting it All Together; taining medical prescriptions were prepared for apothecar- What is on the Horizon ies and physicians in important cities of Europe, including Nuremburg (4), London, Edinburgh, and Dublin (5). BP and USP–early efforts to harmonize pharmacopoeias J. Mark Wiggins is owner and compendial In the 19th century, it was recognized that there were in- consultant with Global Pharmacopoeia Solutions LLC. Joseph A. Albanese is the director of Analytical consistencies in the information contained in the various Strategy and Compliance at Janssen Research and pharmacopoeias which then existed. As a result, there was Development, LLC. an emerging focus on efforts to standardize and harmonize the content in the pharmacopoeias. An early example of the Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 1 Pharmacopoeia Compliance Series Table I. Pharmacopoeia commissions/published pharmacopoeias The development of the compiled from World Health Organization data (1). USP and BP were intended to Pharmacopoeia Pharmacopoeia Pharmacopoeia Pharmacopoeia commission published commission published harmonize drug standards. Argentina# √ Macedonia+ Austria* √ Malta* Belarus## √ Mexico √ need for pharmacopoeial harmonization was the creation Belgium* Montenegro* Bosnia and of the British Pharmacopoeia (BP) in 1858 to overcome the Netherlands* inconveniences and dangers resulting from the existence of Herzegovina* three different pharmacopeias in the United Kingdom and Brazil# √ Norway* Ireland, those of London, Edinburgh, and Dublin (5). Even Bulgaria* Pakistan √ Chilex √ Philippines √ earlier, in 1820, the United States Pharmacopeia (USP) was China √ Poland* √ established by a group of 11 physicians who held the first Croatia* √ Portugal* √ United States Pharmacopeial Convention (USP) in the US Republic of Cyprus* √ Capitol building in Washington, because they recognized Korea the need for consistent standards for the medicines that Czech Republic* √ Romania* √ Russian were being used in the separate states of the relatively young Denmark* √ Federation## “united” country. Information contained in the preface to Egypt √ Serbia* the first edition of the USP provides an early reference to Estonia* Slovak Republic* √ the historical purpose, value, and usefulness of the phar- Finland* Slovenia* macopoeias, which also provides interesting perspectives for France* √ Spain* √ today (6). Modern pharmacopoeias strive to achieve similar Germany* √ Sweden* value and usefulness, while shifting away from historical Greece* √ Switzerland* √ “recipes” that described methods of preparation for medi- Hungary* √ Thailand √ cines, to instead focus on the attributes of drug products and Iceland* Turkey* ingredients that help ensure their identity, strength, quality, India √ Ukraine* √ and purity. The preface to the first edition of the USP con- Indonesia √ United Kingdom* √ tinues with the following remarkable comments that speak Iran √ United States √ to the need and value of harmonization to achieve consis- Ireland* Vietnam √ tency in pharmacopoeial standards (6): Italy* √ Regional/International Japan √ Africa √ Eurasian Kazakhstan## √ √ • “In the United States the evil of irregularity and un- Economic Union## certainty in the preparation of medicines has been felt Latvia* Europe* √ with peculiar weight.” Lithuania* MERCOSUR# √ • “… (A) number of Pharmacopoeias … have been pro- World Health Luxembourg* √ duced in different parts of the Union … and of course Organization++ the character of medicinal preparations is liable to * Pharmacopoeia authorities are a party to the European vary in every state and city of the Union.” Pharmacopoeia Convention. # Participating countries in the MERCOSUR Pharmacopoeia: • “… (A) National Pharmacopoeia … should be estab- Argentina, Brazil, Paraguay, Uruguay. lished and adopted … being evidently the only mode ## Participating countries in the Eurasian Economic Union (EAEU) by which a uniform system could be introduced at Pharmacopoeia: Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russian Federation. once into all parts of the American territory.” x Pharmacopoeia authority not active. The work of the convention that introduced this uniform + Former Yugoslav Republic of Macedonia. system of drug standards and led to the initial creation of ++ The World Health Organization (WHO) publishes the International the pharmacopoeia of the United States continues today, Pharmacopoeia (Ph. Int.). with the next meeting of stakeholders scheduled in May 2020, marking the 200th anniversary of the USP. However, the establishment of the USP in 1820 occurred long before of the 1906 Pure Food and Drug Act (7), nearly a century modern bio/pharmaceutical manufacturing capabilities and after the first USP was published. The USP and National regulatory systems that are in place today around the world Formulary (NF) were subsequently recognized as official to control the quality, safety, and efficacy of drug products. compendia in the 1938 Federal Food, Drug, and Cosmetic Although it was not known by its present name until 1930, Act (FD&C Act). In 1975, USP acquired the previously FDA’s modern regulatory functions began with the passage separate compendium NF and the first combined edition 2 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 PharmTech.com Figure 1: Timeline indicating the year when many of the pharmacopoeias were created. 1898 1962 Local 1820 1858 Argentina Indonesian pharmacopoeias United States British Pharmacopoeia Pharmacopoeia 1964 are created in 2004 2020? Pharmacopeia Pharma- is created is created European 1987 some cities and Philippine EAEU is created – for copoeia Pharmacopoeia is Thailand city-states 1953 Pharma- Pharmacopoeia >20 US states is created – 1929 created – first regional Pharmacopoeia around the globe Modern pharmacopoeia with 8 is created copoeia is first publication – from 3 UK city Brazilian pharma- Chinese member states of the created from 5 Eurasian Pharma- copoeias Pharmacopoeia Council of Europe Economic Union copoeia is created states is created Until 1800 – 1871 – 1951– 1964 – 1986 – Beyond 1800 1870 1950 1963 1985 2020 2020 1844 1846 1866 1886 1951 1958 1970 2008 TBD Indian Mexican Russian Japanese International Korean Vietnam Kazakhstan MECOSUR Pharmacopoeia Pharma- Pharma- Pharma- Pharmacopoeia Pharmacopoeia Pharma- Pharmacopoeia Pharmacopoeia is initially created copoeia is copoeia copoeia is is created by is created copoeia is is created first publication – created is created created WHO created from 4 Southern Common Market (South American) 1955 1980 countries Modern Indian First Combined Pharmacopoeia United States is created Pharmacopeia- National Formulary is published of the USP–NF, as it is known today, was released in 1980. amples bring awareness of the overall timeline for develop- The USP–NF remains unique today among pharmacopoe- ment of the pharmacopoeias and provide the larger