Regulatory Sourcebook Pharmacopoeia Compliance Series IQConcept - stock.adobe.com A Brief History of Pharmacopoeias: A Global Perspective This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.

J. MARK WIGGINS AND JOSEPH A. ALBANESE

he global and historical perspective presented PHARMACOPOEIAS–A GLOBAL herein is critical to understanding the par- PERSPECTIVE AND BRIEF HISTORY ticular challenges that must be overcome to According to the latest index compiled by the World achieve harmonization among the pharmaco- Health Organization (WHO) (1), there are as many as poeias, as well as providing a deeper apprecia- 40 pharmacopoeias published around the world, with Ttion of the important harmonization progress achieved as many as 60 active pharmacopoeia commissions to date. who carry out the work of developing and maintain- Also, by understanding the lack of harmonization, ing these pharmacopoeias (Table I). To better under- the reader will appreciate the complexity it adds to a stand the situation today, it is instructive to consider company’s processes for compendial monitoring and the history of pharmacopoeias. A timeline is provided compliance. in Figure 1 indicating the year when many of the phar-

J. MARK WIGGINS is owner and compendial consultant with Global Pharmacopoeia Solutions LLC. JOSEPH A. ALBANESE is the director of Analytical Strategy and Compliance at Janssen Research and Development, LLC.

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A Practical Guide to Pharmacopoeia Compliance: A Series

In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work to establish effective processes, partnerships, and tools to maintain appropriate and timely compliance across the bio/pharmaceutical industry to the benefit of patients.

The following articles can be found within this ebook and online at www.BioPharmInternational.com/compendia: • Why Pharmacopoeia Compliance is Necessary • Why Pharmacopoeia Compliance is Difficult • A Brief History of Pharmacopoeias: A Global Perspective • Global Pharmacopoeia Standards: Why Harmonization is Needed • Harmonization Efforts by Pharmacopoeias and Regulatory Agencies

Upcoming articles in this series will include the following: • Revision Process for Global/National Pharmacopoeias • Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions • Monograph Development: Why and When to Participate • Monograph Development: How to Participate; How to Harmonize • A Practical Approach to Pharmacopoeia Compliance • A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials • Pharmacopoeia Compliance: Putting it All Together; What is on the Horizon

macopoeias were created. Although BP AND USP–EARLY EFFORTS TO States Pharmacopeial Convention the earliest work presenting medi- HARMONIZE PHARMACOPOEIAS (USP) in the US Capitol build- cal knowledge and herbal remedies In the 19th century, it was recog- ing in Washington, because they may date back more than 3000 nized that there were inconsisten- recognized the need for consis- years to ancient Egypt (2), it was cies in the information contained tent standards for the medicines De Materia Medica, which appeared in the various pharmacopoeias that were being used in the sepa- in the 1st century CE in Greece which then existed. As a result, rate states of the relatively young and Rome that perhaps represents there was an emerging focus on “united” country. the first example of a “pharmaco- efforts to standardize and har- Information contained in the poeia” (3). (The word “pharmaco- monize the content in the phar- preface to the first edition of the poeia” translates from the ancient macopoeias. An early example of USP provides an early reference to Greek as “drug-making”.) This trea- the need for pharmacopoeial har- the historical purpose, value, and tise on medical matters compiled monization was the creation of usefulness of the pharmacopoe- herbal remedies known at the time, the British Pharmacopoeia (BP) in ias, which also provides interesting along with their methods of prep- 1858 to overcome the inconve- perspectives for today (6). Modern aration. Beginning in the 16th niences and dangers resulting pharmacopoeias strive to achieve century, several pharmacopoeias from the existence of three differ- similar value and usefulness, containing medical prescriptions ent pharmacopeias in the United while shifting away from histori- were prepared for apothecaries Kingdom and Ireland, those of cal “recipes” that described meth- and physicians in important cities London, Edinburgh, and Dublin ods of preparation for medicines, of Europe, including Nuremburg (5). Even earlier, in 1820, the United to instead focus on the attributes of (4), London, Edinburgh, States Pharmacopeia (USP) was drug products and ingredients that and Dublin (5). established by a group of 11 phy- help ensure their identity, strength, sicians who held the first United quality, and purity. The preface to

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Table I. Pharmacopoeia commissions/published pharmacopoeias compiled the first edition of the USP contin- from World Health Organization data (1). ues with the following remarkable Pharmacopoeia Pharmacopoeia Pharmacopoeia Pharmacopoeia comments that speak to the need commission published commission published and value of harmonization to achieve consistency in pharmaco- Argentina# √ Macedonia+ poeial standards (6): Austria* √ Malta* • “In the United States the evil ## Belarus √ Mexico √ of irregularity and uncer- Belgium* Montenegro* tainty in the preparation of Bosnia and medicines has been felt with Netherlands* Herzegovina* peculiar weight.” Brazil# √ Norway* • “… (A) number of Bulgaria* Pakistan √ Pharmacopoeias … have been Chilex √ Philippines √ produced in different parts of China √ Poland* √ the Union … and of course the character of medicinal prepara- Croatia* √ Portugal* √ tions is liable to vary in every Cyprus* Republic of Korea √ state and city of the Union.” Czech Republic* √ Romania* √ • “… (A) National Pharmacopoeia Denmark* Russian Federation## √ … should be established and Egypt √ Serbia* adopted … being evidently the Estonia* Slovak Republic* √ only mode by which a uniform Finland* Slovenia* system could be introduced at once into all parts of the France* √ Spain* √ American territory.” Germany* √ Sweden* The work of the convention that Greece* √ Switzerland* √ introduced this uniform system Hungary* √ Thailand √ of drug standards and led to the Iceland* Turkey* initial creation of the pharmaco- India √ Ukraine* √ poeia of the United States contin- ues today, with the next meeting Indonesia √ United Kingdom* √ of stakeholders scheduled in May Iran √ United States √ 2020, marking the 200th anni- Ireland* Vietnam √ versary of the USP. However, the Italy* √ Regional/International establishment of the USP in 1820 Japan √ Africa √ occurred long before modern bio/ Eurasian Economic pharmaceutical manufacturing Kazakhstan## √ √ Union## capabilities and regulatory systems Latvia* Europe* √ that are in place today around Lithuania* MERCOSUR# √ the world to control the quality, World Health safety, and efficacy of drug prod- Luxembourg* √ Organization++ ucts. Although it was not known

* Pharmacopoeia authorities are a party to the European by its present name until 1930, Pharmacopoeia Convention. FDA’s modern regulatory functions # Participating countries in the MERCOSUR Pharmacopoeia: began with the passage of the 1906 Argentina, Brazil, Paraguay, Uruguay. ## Participating countries in the Eurasian Economic Union (EAEU) Pure Food and Drug Act (7), nearly Pharmacopoeia: Armenia, Belarus, Kazakhstan, Kyrgyzstan, a century after the first USP was Russian Federation. published. The USP and National x Pharmacopoeia authority not active. + Former Yugoslav Republic of Macedonia. Formulary (NF) were subsequently ++ The World Health Organization (WHO) publishes the International recognized as official compendia Pharmacopoeia (Ph. Int.). in the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act). In

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Figure 1. Timeline indicating the year when many of the pharmacopoeias were created.

1898 1962 Local 1820 1858 Argentina Indonesian 2020? pharmacopoeias United British Pharmacopoeia Pharmacopoeia 1964 1987 2004 EAEU created in some States Pharma- is created is created European Pharma- Thailand Philippine Pharmaco- cities and Pharma- copoeia copoeia is created – Pharmacopoeia Pharma- poeia first city-states around copeia is is created – first regional is created copoeia is publication – globe 1929 1953 created - from 3 UK Brazilian Modern pharmacopoeia with created from 5 for >20 US city pharma- Pharmacopoeia Chinese 8 member states of Eurasian states copoeias is created Pharmacopoeia the Council of Europe Economic is created Union states

Until 1800 1800-1870 1871-1950 1951-1963 1964-1985 1986-2020 Beyond 2020

TBD 1958 1970 1980 MECOSUR Korean Vietnam First Combined Pharma- Pharma- Pharma- United States 2008 copoeia first 1844 1951 copoeia is copoeia is Indian 1846 International Pharmacopeia- Kazakhstan publication – 1866 1886 created created National Pharmaco- from 4 Pharmacopoeia Mexican Russian Japanese Pharma- Formulary is poeia is Southern is initially created Pharma- Pharma- Pharma- copoeia is 1955 published created Common copoeia is copoeia is copoeia is created by WHO Modern Market created created created Indian (South Pharma- American) copoeia is countries created

1975, USP acquired the previously vide the larger global context to separate compendium NF and the HISTORICAL PERSPECTIVE FOR aid in understanding the continu- first combined edition of the USP– OTHER PHARMACOPOEIAS ing efforts to achieve some degree NF, as it is known today, was released A broader consideration of today’s of compendial harmonization. in 1980. The USP–NF remains unique global community reveals a more Based on traditions for curing today among pharmacopoeias, complex situation with compli- illnesses dating back to the 2nd because it is developed by a private, ance challenges that result from millennium BCE, the classic Shen- non-governmental standards-setting the lack of broad harmonization nung Pen-ts’ao Ching represents organization. Unlike most other across the various pharmacopoe- the oldest known pharmaceuti- pharmacopoeias, which are affili- ias and regulatory agencies around cal work in China, a compilation ated with, or formally part of the the world. The publication of the of traditional Chinese materia regulatory agency in that country or USP in 1820 and the BP in 1858 medica (8). The current Chinese region, the USP–NF is not part of, nor aimed to bring consistency to drug Pharmacopoeia (ChP) also has an is it affiliated with the US FDA. Still, standards for the benefit of phar- interesting history for the estab- USP and FDA have a long-standing macy and medical practitioners lishment of quality standards for collaboration and maintain official and their patients. This objective medicines, reflecting the great contact through a number of estab- has been pursued in other coun- importance attached to medicine lished channels to help ensure the tries, continuing to modern times, and healthcare by the Chinese gov- standards that are published in USP– with the initial development and ernment for the people of China NF and enforced by FDA (among subsequent updates to their phar- (9). In 1949, the year the People’s their many other responsibilities) macopoeias. As noted earlier, there Republic of China was founded, contribute to the quality of medi- are currently as many as 40 phar- the Ministry of Health convened cines. The historical context and macopoeias published around the a meeting of medical and phar- practical considerations in the devel- world, each with its own rich and maceutical experts to compile a opment of the USP and FDA have led unique history, while sharing a national pharmacopoeia for China. to instances where the pharmaco- common goal of providing qual- Over the following several years, a poeia and regulatory requirements ity standards for medicines to ben- process for developing the pharma- in the US are not fully aligned, efit patients. Additional historical copoeia was established, including making it difficult to comply with examples bring awareness of the a secretariat and experts charged both standards. overall timeline for development with carrying out the practical

of the pharmacopoeias and pro- and technical aspects of the work. OF THE AUTHORS FIGURE COURTESY

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The first edition of the Chinese Elsewhere, the first edition of International Pharmacopoeia (Ph. Pharmacopoeia was published in the Russian Pharmacopoeia (now Int.), each of which deserves fur- 1953, containing 531 monographs the State Pharmacopoeia of the ther consideration. for drug substances and products, Russian Federation or SP RF) dates including chemical medicines and back to 1866 (12); it is now in its PH. EUR.–CREATION OF A MODERN, traditional medicines of plant and 14th edition, which was published HARMONIZED PHARMACOPOEIA animal origin. The first addendum (in Russian and on-line only) by In their historical context, the to the 1953 edition was published the Russian Ministry of Health in development of the USP and BP in 1957. Since then, the content in December 2018, with implementa- were intended to harmonize drug the pharmacopoeia has continued tion required by January 2022. standards. But unlike the USP, BP, to expand. The latest (10th) edi- and many other pharmacopoe- tion of the Pharmacopoeia of the The development of ias, the more recent creation of People’s Republic of China, referred the Ph. Eur. occurred within the to as the ChP, was published in the USP and BP were context of modern manufacturing 2015 and consists of four volumes and regulatory systems in Europe covering traditional Chinese medi- intended to harmonize and around the world, providing cines, modern chemical medicines a recent and successful example and antibiotics, biologics, excip- drug standards. of harmonization. In 1964, the ients, and general chapters (10). Convention on the Elaboration ChP 2015 contains more than 5600 The Japanese Pharmacopoeia (JP) of a European Pharmacopoeia, set monographs, 10 times the number was first published in 1886 (13) forth by eight member states of in the first edition, including more and is now in its 17th edition the Council of Europe, established than 1000 new monographs since including two supplements, with harmonized standards for medi- the previous edition that was pub- the 18th edition planned for pub- cines in Europe (5). The conven- lished in 2010, and more than 300 lication in 2021. The pharmaco- tion facilitated the free movement general chapters and requirements. poeias in Mexico and Argentina of medicines throughout member The next edition of ChP is in devel- were first published in 1846 and states and ensured access to medi- opment, with publication planned 1898, respectively (1). The first edi- cines by European citizens. Today, for 2020. tion of the Brazilian Pharmacopoeia this convention has 39 signatory The history of the Indian was published in 1929 (1) and is parties from Europe, including the Pharmacopoeia (IP) (11) began in currently in its 5th edition includ- European Union, in which there 1833, when a committee recom- ing two supplements, with an is mandatory compliance with the mended publication of a pharma- updated 6th edition nearing com- requirements of the Ph. Eur. These copoeia, which was first completed pletion. The Korean Pharmacopoeia member states participate and vote in 1844 and mainly consisted of was first published in 1958 (1); in the European Pharmacopoeia commonly used indigenous rem- the Indonesian Pharmacopoeia Commission sessions, where the edies. A subsequent publication in 1962 (12). Other recent exam- standards published in the Ph. in 1868 included not only the ples include the pharmacopoe- Eur. are adopted (14). Currently, indigenous drugs used in India, ias in Vietnam, Thailand, the there are also 30 observers from but also the drugs of the British Philippines, and Kazakhstan, first all over the world, including the Pharmacopoeia. Then in 1885, the published in 1970, 1987, 2004, and US, China, and WHO, that are BP was made official in India. 2008, respectively (1). able to participate in the scientific After independence from Britain, Each pharmacopoeia was ini- work of the Commission and ben- the Indian Pharmacopoeia tially established to standardize efit from the European experience Commission was established medicines and serve the needs in this area. Observers also gain in 1948, with its main function of patients within their respec- access to the work on the qual- being the publication of IP as the tive country. Today, a global view ity control of medicines and the national pharmacopoeia. The first is necessary in order to meet the methods of analysis in the Ph. Eur., edition of the modern IP was pub- needs of global patients. Within which could further support com- lished in 1955, and the current 8th this perspective, there is a spe- pendial harmonization through edition was published in 2018. cial place held by the European adoption or adaptation of the Ph. Pharmacopoeia (Ph. Eur.) and the Eur. standards.

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The Ph. Eur. marks the creation The Ph. Eur. marks the of the 10th edition of the Ph. Eur., of a single, unified regional phar- which is official in January 2020, macopoeia—it may be argued even creation of a single, EDQM organized an international an international pharmacopoeia— conference in Strasbourg in June providing legally binding stan- unified regional 2019, bringing together leading sci- dards for the quality of medicines entists and experts to exchange and their ingredients in Europe pharmacopoeia—it views and share experiences on all for the signatories to the conven- aspects of the quality of medicines. tion, where previously there had may be argued even The conference, titled “EDQM and been separate pharmacopoeias in European Pharmacopoeia: State-of- each member country. This rep- an international the-Art Science for Tomorrow’s resents an important advance in Medicines,” highlighted devel- the historical evolution of phar- pharmacopoeia. opments in the Ph. Eur. to help macopoeias to move toward global ensure that modern pharmaco- standards. With this achievement, poeias continue to make a vital why are there still pharmacopoe- An article written by the contribution to the protection of ias in some individual countries Director of the European public health. in Europe? Maintaining a national Directorate for the Quality pharmacopoeia in these countries of Medicines and HealthCare OTHER REGIONAL provides text that is either of inter- (EDQM) provides perspective on PHARMACOPOEIA INITIATIVES est to one member state only, or the continuing role of the phar- There have been other efforts to out of scope of the Ph. Eur. (e.g., macopoeia in the 21st century (3). support the harmonization of national formularies) (15). Three The article describes how pharma- pharmacopoeia standards between main approaches were taken in copoeias continue to modernize several countries in a particular Europe following the creation in changing times to support the region, drawing on the success- of the Ph. Eur., with the decision availability of affordable medi- ful experience of the Ph. Eur. The being country specific: cines without compromising MERCOSUR pharmacopoeia is • Discontinuation of the national their quality, safety, and efficacy. being developed to provide har- pharmacopoeia (e.g., Sweden, The 9th edition of the Ph. Eur., monized compendial standards for Finland, Netherlands); Ph. Eur. which became official in January four Southern Common Market established as the only pharma- 2017, has continued to add new (South American) countries: Brazil, copoeia, potentially translated and revised general chapters and Argentina, Paraguay, and Uruguay. into the national language monographs, including the pub- The Eurasian Economic Union • Inclusion of the Ph. Eur. con- lication of the first monograph (EAEU) pharmacopoeia, currently tent in the national pharma- for a finished product containing under development, is intended copoeia (e.g., United Kingdom a chemically defined active sub- to provide a core set of require- [BP], Spain) stance. The Ph. Eur. has moved to ments for the quality of medicinal • Publication of the national allow the use of reverse osmosis products in the countries of the pharmacopoeia in addition for the production of water for Eurasian Economic Union, which to the Ph. Eur. (e.g., France, injections (WFI) and has increased includes the Russian Federation, Germany, Switzerland, Austria). focus on impurities, quality by Armenia, Belarus, Kazakhstan, and Regardless of the approach design (QbD), process analytical Kyrgyzstan. It will be interesting taken, the standards contained technology (PAT), and biothera- to monitor the continued devel- in the Ph. Eur. remain mandatory peutic products, including mono- opment of these pharmacopoeias, in these countries, even as their clonal antibodies (mAbs). EDQM, including how the published com- national pharmacopoeia serves to which publishes the Ph. Eur., has pendial standards are received and complement the content of the also recognized that a high per- accepted by the health authorities Ph. Eur. by including standards centage of APIs come from outside in these countries and around the for drug products and ingredi- Europe, Japan, and the US, leading world. It remains to be seen if the ents that are applicable in that to even further need to strengthen existing national pharmacopoe- individual country. the collaboration among pharma- ias will continue to exist, or if they copoeias. To mark the publication

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will be discontinued or absorbed in substances and dosage forms. These the Netherlands, Switzerland, the new regional publication. are intended to serve as source the United Kingdom, and the material for reference or adapta- United States. PH. INT.–TOWARD GLOBAL tion by any WHO Member State In 1947, WHO took over the work PHARMACOPOEIA STANDARDS (194 countries) wishing to establish begun under the League of Nations With the inclusion of “inter- pharmaceutical requirements (17). for the unification of pharmacopoe- national” in its title and con- From a compliance perspective, it ias. The first edition of the Ph. Int. sidering the numerous other is important to understand that the was published in two volumes (1951 pharmacopoeias also in exis- Ph. Int. only has legal status when- and 1955) and a supplement (1959) tence today, it is useful to under- ever a national or regional author- in English, French, and Spanish, stand the history and specific role ity expressly introduces it into and also translated into German played by the Ph. Int. in the global appropriate legislation. and Japanese. The Ph. Int. was orig- pharmacopoeia landscape. The ultimate goal of the Ph. Int. inally published with the aim of is to provide quality control speci- creating a worldwide, unified phar- The ultimate goal fications to help enable access to macopoeia and relied on collabora- quality medicines worldwide. The tion with national pharmacopoeia of the Ph. Int. is to Ph. Int. is published by WHO with commissions for its preparation. the aim to achieve wide global har- However. it was recommended that provide quality control monization of quality specifications Ph. Int. was not intended to be a for selected pharmaceutical prod- legal pharmacopoeia in any coun- specifications to ucts, excipients, and dosage forms. try unless adopted by the pharma- Compared to other pharmacopoe- copoeial authority of that country. help enable access ias, priority is given to medicines In 1975, the purpose of the Ph. Int. that are included in the WHO was reconsidered. It was decided to quality medicines Model List of Essential Medicines that the publication should focus and to medicines that are impor- more on the needs of developing worldwide. tant for WHO health programs; the countries, applying simple, classical needs of developing countries are chemical techniques for the test- Among its many responsibili- taken into account (17). However, ing of medicines. Priority would ties, WHO provides important sup- this focus on essential medicines be given to drugs that were widely port to global healthcare through and developing countries is a fairly used throughout the world, with the publication of the International recent development and was not emphasis on the therapeutic value Pharmacopoeia. The work on the always the primary intention of the of these drugs. High priority would Ph. Int. is carried out in collabora- Ph. Int. Indeed, the goal of achiev- be accorded to drugs important tion with members of the WHO ing harmonized pharmacopoeia to WHO health programs, and to Expert Advisory Panel on the standards for drug quality is deeply those likely to contain impurities International Pharmacopoeia and rooted in the history of Ph. Int., arising from degradation or due to the WHO Expert Committee on which dates back to 1874 when the difficulties in their manufacture. Specifications for Pharmaceutical need to standardize terminology Since 1979, monographs in Ph. Int. Preparations. Also involved in this and to specify dosages and compo- have provided specifications for the work are specialists from regula- sition of drugs led to attempts to identification, purity and content tory authorities, from industry and produce an international pharma- for drugs in the WHO Model List of from other institutions, including copoeia (18). In 1937, the League Essential Medicines. national drug quality control labo- of Nations set up an expert com- As with all pharmacopoeias, the ratories, WHO collaborating cen- mittee in response to repeated calls activities related to Ph. Int. pro- ters, and other standards-setting from pharmaceutical experts in vide an important element in the organizations (16). The eighth edi- various countries to coordinate the overall quality assessment of bio/ tion of Ph. Int. was published in work of national pharmacopoeia pharmaceuticals, thereby contrib- 2018 and constitutes a collection commissions and develop a uni- uting to the safety and efficacy of of recommended procedures for fied pharmacopoeia. The first com- medicines. Currently, the focus analysis and specifications for the mittee comprised seven experts for Ph. Int. is on essential medi-

FIGURE CREDIT HERE CREDIT FIGURE determination of pharmaceutical from Belgium, Denmark, France, cines, and more recently on pri-

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ority medicines of major public sented herein to further explore 7. FDA, “The History of FDA’s Fight for health importance, for instance, the need for harmonization of Consumer Protection and Public medicines to treat malaria, tuber- compendial standards, with discus- Health,” FDA.gov, www.fda.gov/ about-fda/history-fdas-fight-con- culosis, and HIV/AIDS, as well as sion about some of the approaches sumer-protection-and-public-health, medicines for children. However, that are underway to reach this Accessed July 11, 2019. from the earliest times, dating important goal. Later articles will 8. P. U. Unschuld, Medicine in China: A back to 1874, the objective had build on this information to pro- History of Pharmaceutics (University actually been to create a unified pose a practical basis for classify- of California Press, pp. 14-16, 1986). 9. Chinese Pharmacopoeia Commis- pharmacopoeia that could be ing pharmacopoeias as “global” or sion, “History of the Pharmacopoeia used around the world—truly an “national”, which enables a thor- of the People’s Republic of China,” international pharmacopoeia. ough consideration of the variety ChP, Vol. 1, pp. XIII - XXIII (China of approaches that may be taken by Medical Science Press, 2015). bio/pharmaceutical companies to 10. Chinese Pharmacopoeia Commis- The history of the sion, “Preface,” ChP, Vol. 1, pp. IX - meet health authority expectations XII (China Medical Science Press, pharmacopoeias around the world in regard to phar- 2015). macopoeia compliance. 11. Indian Pharmacopoeia Commission, around the world “About IP–History of IP,” ipc.gov.in, ACKNOWLEDGMENT https://ipc.gov.in/mandates/indian- pharmacopoeia/about-ip.html, Ac- reveals a common The authors gratefully acknowl- cessed July 11, 2019. edge the contribution of Susan J. 12. WHO, “International Meeting of purpose to support Schniepp for her technical review World Pharmacopoeias”, WHO.int, and helpful suggestions during the www.who.int/medicines/areas/qual- preparation of this series of articles. ity_safety/quality_assurance/re- the health of the sources/qas_worldpharmmeeting/en/, Accessed June 26, 2019. population through 13. PMDA, “JP History and Legal Status”, REFERENCES Japanese Pharmacopoeia–About JP, consistent standards 1. WHO, “Index of World Pharmaco- pmda.go.jp, www.pmda.go.jp/ poeias and Pharmacopoeial Authori- files/000210780.pdf, Accessed June ties,” World Health Organization, 26, 2019. for medicines. Working Document QAS/11.453/ 14. EDQM, “Membership & Observer- Rev.10, January 2018, www.who.int/ ship,” EDQM.eu, www.edqm.eu/en/ CONCLUSION medicines/publications/pharmaco- membership-observership, Accessed The history of the pharmacopoe- poeia/index-of-pharmacopoe- July 18, 2019. ias around the world reveals a com- ias_17012018.pdf?ua=1 15. C. Vielle, “The European Pharmaco- 2. New York Academy of Medicine, poeia–Part 1,” Presentation at the mon purpose to support the health “Academy Papyrus to be Exhibited at Workshop The Chinese and Euro- of the population through consis- the Metropolitan Museum of Art,” pean Pharmacopoeias–The New Edi- tent standards for medicines. Early Press Release, July 2005, https://web. tions, Strasbourg, France (October 17, examples, like the creation of the archive.org/web/20101127161922/ 2016), www.edqm.eu/sites/default/ USP and BP at a national level, as http://nyam.org/news//2493.html, files/1710_1420_cv_presentation_ Accessed September 9, 2019. chp_meeting.pdf well as later examples, such as the 3. S. Keitel, PDA Letter, April 2019, 16. WHO, “The International Pharmaco- Ph. Eur. on a regional level, also www.pda.org/pda-letter-portal/ poeia (Ph. Int.),” WHO.it, www.who. show an emphasis on trying to har- home/full-article/the-pharmacopeia- int/medicines/publications/pharma- monize the quality standards con- in-the-21st-century copoeia/en/, Accessed June 10, 2019. tained in the pharmacopoeias. The 4. A. Arber, Herbals, Their Origin and 17. WHO, “The International Pharmaco- Evolution: A Chapter in the History of poeia, 8th Edition,” Library Homep- history of the Ph. Int. demonstrates Botany, 1470–1670, (Cambridge Uni- age (WHO Department of Essential that the vision of creating a unified, versity Press, p. 66, 1912). Medicines and Health Products, international pharmacopoeia is not 5. S. Keitel, Pharmaceutical Technology 2018), https://apps.who.int/phint/ new; the goal of such a pharmaco- 34 (4), pp. 120-121 (April 2010). en/p/about/ poeia, which could support public 6. USP, The Pharmacopoeia of the 18. WHO, “The International Pharmaco- United States of America, Copyright poeia, 8th Edition,” Background to health at a global level goes back United States Pharmacopeial Conven- Previous Editions (WHO Depart- nearly 150 years. tion, Inc., Facsimile of First Edition ment of Essential Medicines and The next articles in this series (1820), Published by the American Health Products, 2018), https://apps. will use the historical context pre- Institute of the History of Pharmacy, who.int/phint/en/p/docf/BP Madison, Wisconsin (2005).

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