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WHO Drug Information Vol. 27, No. 2, 2013

The International Pharmacopoeia

International Meeting Compared to national and regional pharmacopoeias, The International of World Pharmacopoeias Pharmacopoeia (Ph. Int.) is issued by A pharmacopoeia is a legally binding WHO as a recommendation with the collection of standards and quality aim of providing international standards specifications for used – including less technically demanding in a country or region. Within the alternatives where needed — for pharmacopoeia, a quality specification is adoption by Member States and to help a set of appropriate tests that will confirm achieve a potentially global uniformity the identity and purity of the product, of quality specifications for selected ascertain the strength (or amount) of the pharmaceutical products, excipients and active substance and, when needed, the dosage forms. performance characteristics. Reference substances are used in testing to help In response to a call for input, and ensure the quality, such as identity, as follow-up to discussions with strength and purity, of medicines. representatives of world pharmacopoeias during the International Conference of A pharmacopoeia also covers pharma- Drug Regulatory Authorities in Hong ceutical starting materials, excipients, Kong in 2002 and in Madrid in 2004, intermediates and finished pharma- WHO organized the International Meeting ceutical products (FPPs). General of World Pharmacopoeias in early requirements may also be given on 2012. The aim was to discuss topics of important subjects related to medicines common interest and address identified quality, such as analytical methods, challenges. microbiological purity, dissolution testing, or stability (1). In order to prepare for the meeting, WHO provided a set of preliminary The role of a modern pharmacopoeia questions on pharmacopoeias to meeting is to furnish quality specifications for participants in an effort to inspire input to active pharmaceutical ingredients (APIs), the agenda. The questions, presentations FPPs and general requirements. The and final report are now available on a existence of such specifications and dedicated web site (3). This article is a requirements is necessary for the proper summary of the report. functioning or regulatory control of medicines production. Pharmacopoeial Pharmacopoeia: publication and requirements form a basis for establishing frequency of updates quality requirements for individual The pharmacopoeia, as a public tool, pharmaceutical preparations. maintains quality of medicines by collecting the recommended procedures According to the information available for analysis and specifications for to the World Health Organization the determination of pharmaceutical (WHO), 140 independent countries are substances, excipients and dosage at present employing thirty national forms and, in most cases, consists of a as well as African, European and general part (tests, methods and general International Pharmacopoeias (2). requirements) and a specific part in the

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Questions proposed to pharmacopoeias

1. Name of pharmacopoeia. 2. Is pharmacopoeia referred to in national/regional legislation – if yes, which? 3. Does national/regional legislation make reference to other national, regional, or internatio- nal pharmacopoeias(s) – if yes, which? 4. When was publication of latest edition?

5. What is the update frequency – annually, biannually, other (please specify). 6. For which products does the pharmacopoeia provide specifications?APIs, dosage forms, products, biologicals, traditional medicines, etc. (please specify) 7. What number of texts are included in the pharmacopoeia monographs for APIs, finished dosage forms, biologicals, and general monographs? 8. Is there collaboration with and/or being part of a (different) national/regional pharmaco- poeia – if yes, which? 9. Is there publication of harmonized pharmacopoeial texts within the pharmacopoeia if yes, which pharmacopoeia, which type, how many? 10. Interaction with stakeholders, including regulators? 11. What is the strategy for the future? form of monographs for pharmaceutical Legal basis and references substances. Pharmaceutical analysis to other pharmacopoeias represents a platform through which Pharmacopoeias are referred to in state-of-the-art research can affect the legislation which confirms their legally quality, safety and efficacy of medicines binding status in the relevant country or directly by pharmacopoeial application of region. scientific results into everyday practice. In Europe, a regional approach is used. Transparency and scientific progress the (Ph. are the driving forces behind the need to Eur.) was created by eight Member constantly update all pharmacopoeias. States in 1964 and today consists of Discussion of internationalization 36 Member States and the European and unifying principles for the quality Union (EU) which are signatories to of medicines will require mindful the Convention on the Elaboration of consideration of the different languages a European Pharmacopoeia. Ph. Eur. and medicines regulatory activities members are: Austria, Belgium, Bosnia among countries. and Herzegovina, Bulgaria, Croatia, Most pharmacopoeial commissions take Cyprus, Czech Republic, Denmark, measures to update their pharma- Estonia, Finland, , Germany, copoeias in a timely manner. The Greece, , Iceland, Ireland, , updates are performed through the Latvia, Lithuania, Luxembourg, (the publication of supplements and addenda former Yugoslav Republic of) Macedonia, or by partial revision. More than half Malta, Montenegro, Netherlands, Norway, the pharmacopoeias represented at the Poland, , Romania, Serbia, meeting are updated annually. , Slovenia, , Sweden,

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Switzerland, Turkey, United Kingdom, pharmacopoeia is also accepted in and the EU. In addition, there are 24 legislation for and other countries observers, comprising 23 countries and where Portuguese is an official language. WHO. WHO’s International Pharmacopoeia EU Directives stipulate that ″the (Ph. Int.) is «ready for use» by Member monographs of the European States. The Ph. Int. is referred to in a Pharmacopoeia shall be applicable number of national legislations due to its to all substances, preparations and applicability. pharmaceutical forms appearing in it. In respect of other substances, each For which products does Member State may require observance of the pharmacopoeia provide its own national pharmacopoeia.″ These specifications? directives are transposed into national A large number of products are usually legislation of EU Member States. covered, reflecting the diligence and commitment of pharmacopoeial Some of the 36 Member States of the authorities and their appointed experts Ph. Eur. Convention have decided to develop a comprehensive working to discontinue their own national tool with up-to-date scientific data. pharmacopoeia and use only the Ph. Eur. The complexity and diversity of most Examples are Sweden and Finland. pharmacopoeias results from mutual Other Member States of the Ph. Eur. integration and interdependence with Convention have decided to continue monographs for various types of products their national pharmacopoeia for products such as active pharmaceutical ingredients of solely national interest. In , (APIs), excipients, herbal products, for instance, the Pharmacopoea Helvetica biologicals (vaccines, blood products), (Ph. Helv.) exists alongside the Ph. Eur. radiopharmaceuticals, dosage forms and and the two together form the legally homeopathic preparations. binding pharmacopoeia. In France, the pharmacopoeia consists of the texts of It may be noted that there is a majority of the European Pharmacopoeia and of finished dosage forms, which generally the French Pharmacopoeia, including can be defined as the form of active the ″overseas″ pharmacopoeia. Other ingredient which is or is intended to be countries, such as the United Kingdom, dispensed or administered to the patient have decided to fully integrate the and requires no further manufacturing texts of the Ph. Eur. into their national or processing other than packaging pharmacopoeia; hence the British and labelling. This is in parallel to Pharmacopoeia (BP) contains the texts the decreasing tendency of specific of the Ph. Eur. in addition to the national national monographs for APIs within texts of the BP. some national pharmacopoeias due to replacement with monographs from National/regional legislation often regional or international pharmacopoeias. includes reference to other pharmaco- poeias in the event that their own As the pharmacopoeia itself has pharmacopoeial texts are not available. emerged from experience gained Thus the EU pharmaceutical legislation throughout the centuries, the roots of and hence the legislation of all EU this valuable knowledge can still be seen Member States includes references both in contemporary as traditional at the national/regional and international medicine monographs, represented levels. Historic and language ties also mainly in the pharmacopoeias of , play a role. For example, the Portuguese France (overseas), Japan and Ph. Eur.

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Likewise, homeopathic approaches are of participation occur. Active participants, represented in pharmacopoeias in Brazil, such as members of Ph. Eur., can Germany and , for example. contribute their share of pharmacopoeial development, while passive forms of The pharmacopoeias reviewed at participation may include observational the International Meeting of World missions to benefit from the experience of Pharmacopoeias contain standards for other countries in specific areas and gain chemical and biological drug substances, access to the work on quality control of dosage forms, compounded preparations, medicines and methods of analysis used. excipients, medical devices and dietary supplements. During the current Leading world pharmacopoeias promote meeting some countries, such as Brazil, constant progress within pharmacopoeial France, Germany, Mexico, Serbia and development, ″good pharmacopoeia Switzerland, provided examples of practice″ and recommendations of incorporating a national for procedures for analysis intended to hospital and/or community serve as source material for reference or preparations into their pharmacopoeias. adaptation by any of their Member States In Portugal, there is a non-official national wishing to establish pharmaceutical formulary which is published by the requirements. Portuguese Association. During the meeting, examples were given Ph. Int. provides an opportunity of types of monographs with less frequent to comment on drafts by all world occurrence than other types. pharmacopoeias and offers participation in meetings, such as consultations and For example, monographs for blood Expert Committees during the WHO products were presented by Argentina consultation process. There are also (12), Brazil (20) and India (21), while WHO special projects covering quality monographs for vaccines were presented assurance of medicines worldwide, by Argentina (21), India (57), Kazakhstan such as collaboration with the African (15) and Ukraine (26). Homeopathic Pharmacopoeia, , preparations described in monographs Chinese Pharmacopoeia, Council of were presented mainly by France Europe/Ph. Eur. and the Pharmacopoeial (320), Germany (120) and Mexico (558) Discussion Group (PDG). and finally monographs for were given as an example Ph. Eur. covers all national pharmaco- by China (2165). A total of 92 herbal, poeias of the signatory parties to the traditional herbal and homeopathic Convention, who are members of the monographs are present in the British Ph. Eur. with emphasis on complement- Pharmacopoeia 2012. Supplementary arity, thereby reducing duplication of information is included in some of the work. In some member countries of pharmacopoeias, for example general the Ph. Eur. national pharmacopoeias texts, reference tables, and texts on complement the Ph. Eur. for texts of methods of analysis, reagents, materials/ interest to one Member State only. containers, sutures, and reference Some member countries also republish substances used in national monographs. Ph. Eur. monographs in their national pharmacopoeias. Membership and Collaboration among observership enables States to pharmacopoeias participate in Ph. Eur. Commission Pharmacopoeial authorities collaborate at sessions even if only Members are both regional and international levels for entitled to vote. Within these sessions, the sake of harmonization and exchange each Member State is represented by its of experience. Active and passive forms national delegation consisting of not more

122 WHO Drug Information Vol. 27, No. 2, 2013 The International Pharmacopoeia than three members. On all technical collaboration of the Czech Republic matters delegations cast a vote. The EU with the Slovak Republic results from decides on behalf of EU Member States a common history. Agreements for in all non-technical issues of the Ph. Eur. collaboration have been signed between Each Member State and observer can countries to increase the degree of also propose national experts for each compatibility, such as the USP with group of experts or working party. Mexico. Ukraine has also signed a collaborative agreement with USP, while The European Medicines Agency intensively working with Kazakhstan. A (EMA) participates in the sessions of memorandum of understanding has been the Ph. Eur. Commission and working signed by both the British Pharmacopoeia parties of interest. The European (BP) and Ph. Int. to use and incorporate Directorate for the Quality of Medicines developed monographs mutually. and HealthCare (EDQM) participates in relevant committees and working parties Intensive collaboration with China’s at the level of the EMA alongside national pharmacopoeial authorities was competent authorities. In addition, annual described by representatives of the meetings are organized between EDQM British and French Pharmacopoeias and national pharmacopoeial authorities. and USP during the meeting. France Thirty-six Member States and the EU collaborates with Algeria, Morocco are signatories to the Convention on and Tunisia due to the fact that the the Elaboration of a European Pharmaco- French language is used in those poeia. pharmacopoeias. Brazil and Viet Nam Observership to the Ph. Eur. allows for are also named as collaborators with the participation in the scientific work of the French Pharmacopoeia. In information European Pharmacopoeia Commission. sent to WHO, Korean pharmacopoeial Observer examples are Belarus, Brazil, representatives mentioned bilateral China, , the United States of memoranda of understanding with America, and WHO. Ph. Eur. and USP. The Pharmacopoeial Discussion Group Publication of harmonized (PDG) consists of representatives pharmacopoeial texts within of three pharmacopoeias: Ph. Eur., the pharmacopoeia Japanese Pharmacopoeia (JP) and The PDG has defined harmonization of the United States Pharmacopoeal a pharmacopoeial monograph or general Convention (USP). Its main activities are chapter as follows: retrospective harmonization of general chapters and excipient monographs. In ″A pharmacopeial general chapter addition, Ph. Eur. and USP are running a or other pharmacopeial document is pilot project on prospective harmonization harmonized when a pharmaceutical of active pharmaceutical ingredient substance or product tested by the monographs. document’s harmonized procedure yields the same results and the same accept/ MERCOSUR, as an example of intensive reject decision is reached.″ (4). collaboration at the regional level, and is formed by Argentina, Brazil, When using a fully harmonized pharma- Paraguay and Uruguay. Texts and copoeial monograph or general chapter, chapters are discussed for inclusion in an analyst will perform the same the MERCOSUR Pharmacopoeia. procedures and reach the same accept/ reject decisions irrespective of which Some collaboration is historically and PDG pharmacopeia is referenced. geographically related. Traditional This is called interchangeability and

123 The International Pharmacopoeia WHO Drug Information Vol. 27, No. 2, 2013 each pharmacopoeia identifies, in texts in the USP-NF, where 41 of 61 of an appropriate manner, each fully excipient monographs and 28 of 35 of harmonized monograph and general general chapters have been harmonized chapter. so far. The realization that it was important America to have an independent evaluation of Countries participating within medicinal products before they are MERCOSUR have included harmonized allowed on the market was reached texts in their national pharmacopoeias at different times in different regions. after discussion. PDG texts are also In many cases action was driven by considered during discussions of the tragedies, such as that with sulfanilamide Brazilian Pharmacopoeia Committee. in the USA in 1937 and with thalidomide Mexico does not have a formal process in the 1960s. Therefore, the urgent need for the harmonization of information to rationalize and harmonize regulation with other pharmacopoeias, but its drug was impelled by concerns over rising monographs are consistent in their costs of health care, escalation of the specifications with the BP, Ph. Eur. and cost of research and development and USP in 60–100%. the need to meet public expectations for a minimum delay in making safe and Ph. Int. collaborates worldwide and has efficacious new treatments available to texts harmonized from various sources patients in need. due to its rich collaboration. With the British Pharmacopoeia, this resulted in Eastern Europe three texts adopted in 2010, with 19 in The majority of the State Pharmacopoeia the pipeline. Also, through collaboration of the Republic of Kazakhstan is with PDG, 12 general methods were formed from harmonized texts, including adopted in Ph. Int. in 2011 with more in general chapters and monographs, mono- the pipeline for methods of analysis and graphs on pharmaceutical substances, supplementary information. monographs on vaccines for human use and human immunoglobulins. In the Interaction with stakeholders, Ukrainian Pharmacopoeia Supplement, including regulators there are seven harmonized monographs There are many ways for national/ for finished dosage forms, four are regional pharmacopoeial authorities pursuant to the ″Grant of Rights to Copy to interact and be influenced by and Adapt the USP-NF ″ contract. Eleven stakeholders, particularly through public draft monographs for the 2nd Edition forums. have already been elaborated. The most common interactions are at national level between national and Asia regional regulatory authorities, quality Japan contributes to harmonization control laboratories and different efforts with its counterparts – Ph. Eur. institutions related to quality assurance of and USP – within the PDG and the medicines. Fusion of academic, clinical Japanese Pharmacopoeia contains and industrial fields, such as universities general tests (14), general information and other academic bodies, hospital (11) and excipient monographs (31) and community pharmacies organized as harmonized texts. The Korean in expert groups, and manufacturers Pharmacopoeia has harmonized PDG worldwide through their organizations, texts for general tests. represent a platform for comprehensive and progressive discussion. North America USP incorporates PDG-harmonized To enable harmonization and a reliable

124 WHO Drug Information Vol. 27, No. 2, 2013 The International Pharmacopoeia source of fluid information exchange Ph. Int. specifications. Keeping the costs at the global level, international of analysis in mind, especially in the case organizations (UNAIDS, UNFPA, of developing countries, Ph. Int. provides UNICEF, World Bank, WIPO, WTO, standards for major public health needs. WCO), international professional and other associations, nongovernmental Regional organizations (FIP, IFPMA, IGPA, MSF, Ph. Eur. supports innovation and WMA, WSMI), quality control laboratories flexibility without losing the aim of a (other than national/regional), United pharmacopoeia to provide official, Nations-related organizations such as the recognized and technically sound quality Global Fund to Fight AIDS, Tuberculosis standards. It also remains at the forefront and , and WHO programmes in the biofield and constantly increases including International Nonproprietary pharmacopoeial harmonization through Names, Prequalification of Medicines, collaboration, i.e. as part of PDG, Medicines Regulatory Support, Medicines and maintains observers within other Safety, Traditional Medicines, Quality, pharmacopoeial institutions worldwide. Safety and Standards and specific Ph. Eur. Member States Sweden and disease programmes, are all stakeholders Finland continue to cooperate and be in collaboration. active in the elaboration of the Ph. Eur.

Specific harmonization issues are National discussed within regional and inter- Croatia is currently preparing a regional harmonization groups (ASEAN, publication of a new edition of the GCC, ICH, PANDRH, SADC, etc.). Croatian Pharmacopoeia. To ensure discussion and pragmatic approaches, annual science and standard The Czech Republic would like to symposia are organized, as well as public complete a national formulary, mainly in forums, for an unbiased outside view on the field of paediatrics through coopera- particular issues. tion with the chamber of paediatricians. Assessment of stability in the pharmaco- Strategy for the future poeia formularies for small-scale products Strategies of the individual pharmaco- and products prepared in pharmacies poeias differ for geographical and have also been mentioned as a future economic reasons and depending on the plan by Czech representatives, as well as level of integration to respective regional establishment of a new group of experts international systems. There was a from hospital pharmacies and certified commitment to establish comprehensive, laboratories. updated editions with highly compatible standards at a national or regional France presented its strategy for the level, as well as intentions to harmonize future at both the national and European intensively with emphasis on increased levels. Publication online will define new quality assurance of medicines around policy and reinforce the code of practice the world. in line with the new French Public Health Law. France defines the work programme International based on both interest of patients or pro- Ph. Int. commits to fulfilling the mandate fessionals (paediatric, ophthalmic and of WHO given by its Member States and homeopathic preparations) and conforms responds to the needs of the latter. As to regulation and national strategy an international body, it also responds to (French overseas territories). As a key the needs of quality control laboratories player within the Ph. Eur., France would for post-marketing surveillance and like to contribute to specific topics maintains the international applicability of such as biological products, cell

125 The International Pharmacopoeia WHO Drug Information Vol. 27, No. 2, 2013 and tissue therapies, anti-allergenic corresponding monographs of the leading products, antiseptic preparations, world pharmacopoeias. This will be paediatric preparations, traditional herbal assisted by participation of the Federal preparations and collaboration with P4 State Budgetary Institution “Scientific procedures. Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the In addition to its contribution to the Russian Federation in the work of the Ph. Eur., Germany focuses on particular WHO Expert Committee on Specifications technical issues in terms of pharma- for Pharmaceutical Preparations, work ceutical analysis such as identification of of the EDQM (as an observer) and work materials by the evaluation of analytical of the WHO Working Group on Good fingerprinting, use of non-destructive Pharmacopoeial Practices. spectroscopic methods, imaging techniques for the intact pharmaceutical United Kingdom representatives preparations, trace analysis of impurities presented priorities at the international and simplified analytical identification level. Contributions and intensive tests for certified substances. collaboration within the Ph. Eur. were also described. National activities of As a country collaborating closely with the BP will focus on the Annual BP and the Ph. Eur., Portugal is focusing on its BP (Vet) Publications, British Approved future plan to update national texts and Names Supplements, increase in New to tighten the links with Portuguese- Formulated Preparation Monographs speaking countries and stakeholders. (licensed and unlicensed), Supplementary Serbia will prepare its national addition Chapters for BP and BP (Vet), Red Tape to Ph. Eur., update national ″Magistral Challenge, Stakeholder Cooperation Formularies″ and continue cooperation (manufacturers, practition- with the Ph. Eur. ers, pharmacies, etc.) and tailored publications. Spain plans to follow the timetable for publication of the in-force Ph. Eur. Japan‘s efforts toward internationalization successive editions (simultaneous of its pharmacopoeia are based on translation), to work with internal prompt publication and further improve- Spanish groups that support work of the ment of the JP English edition and experts and specialists in European and web site. Building up the framework for international groups and continue its international information exchange among efforts to cooperate with the work of the pharmacopoeias will also be intensified. Ph. Eur. and international groups. For its next revision JP commits itself to follow-up of the revision of ″General Switzerland focuses on participation Rules for Preparations ″ in JP16: general in the activities of the Ph. Eur. in the quality tests for preparations would framework of the legally binding mandate be newly set, containers and storage of the Ph. Eur. Convention. section revised, and a new framework Introduction of quality standards of the for monographs of drugs created whose Russian Federation Pharmacopoeia manufacturing processes are different, (SP RF) 12th edition (Vols 1–5) in the including impurities (including residual territory of the Russian Federation, solvents), process-related substances, development of new quality standards impurities in biotechnology products and for medicinal products and review of tests for preparations. the older ones, will help to upgrade the national regulatory system. Plans for China provided information to WHO the future also include harmonization stating that the country is committed to of the SP RF monographs with the more cooperation with other world leading pharmacopoeias.

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poeial Commission are strengthening India, in terms of sharing of information of regional harmonization through joint among pharmacopoeias, would like to development of reference standards and focus on resources, working in pockets harmonization of general methods and where there is a need for sharing informa- monographs in order to establish similar tion and providing commitment to quality standards within the region. monitoring, harmonizing with leading pharmacopoeias. Provision of quality Brazil commits to continuing its integra- medicines will be improved through tion with the MERCOSUR Pharma- harmonized drug standards and copoeia and aligning the Brazilian monitoring the quality of medicines Pharmacopoeia with public health needs through an effective regulatory system. and public policy development.

Indonesia’s plans are to publish a new Mexico wants to stay tuned to the needs edition of the Indonesian Pharmacopoeia of the health authority and users, to every five years, to publish the supple- maintain its current pharmacopoeia, ment annually for the existing pharmaco- continue promoting the approach of poeia and to publish the pharmacopoeia users to participate in the development in an English version. of monographs and establish closer Korea has informed WHO that it aims communication with colleagues in other to include in its pharmacopoeia all parts of the world. medicines which are relevant from the viewpoint of health care and medical North America treatment. It will revise it in a timely USP strategy focuses on creating manner for more efficient application and monographs in ways that rely on both will follow international harmonization. the traditional donor model as well Transparency will be important in revision as on research and development in of the Korean Pharmacopoeia, and the its own laboratories. In support of the document will be publicly available and second approach, USP has created the include up-to-date analytical methods and Medicines Compendium (MC), a freely preparation of reference standards. available, online-only compendium of public standards for medicines approved Eastern Europe in any country. The MC monographs A future strategy for Kazakhstan will provide performance tests for critical include the introduction of the State quality attributes and acceptance Pharmacopoeia, further harmonization criteria, a source-independent reference with Ph. Eur. and USP and development, procedure and one or more acceptable edition and revision of its own mono- procedures submitted by manufacturers. graphs. The MC strives to make available Ukraine would like to transform its reference materials for all possible status from observer at the Ph. Eur. impurities associated with a particular Commission to membership, support monograph, and to expand approaches leading pharmacopoeias and implement to include USP-NF, where many harmonized standards. It aims to facilitate monographs are missing and more need the movement of high-quality medicines updating. USP is also strengthening through developing pharmacopoeial its ability to develop impurity reference educational programmes and expanding materials independently through synthetic visiting scientist programmes. capabilities. Latin America In addition, USP is working on The priorities for Argentina’s Pharmaco- standards with allied activities in

127 The International Pharmacopoeia WHO Drug Information Vol. 27, No. 2, 2013 support of manufacturers, regulatory including analytical fingerprinting, non- bodies and others. Examples include destructive spectroscopic methods and a ″global comparator product″, as well imaging. Lastly, support was reiterated as emphasis on biological medicines for maintenance of the international standards in support of new, biosimilar applicability of Ph. Int. specifications. and interchangeable biological products. Individual presentations, the full report USP is working on spectral imaging and conclusions are to be found on the approaches that allow field approaches WHO web site (3). to assure identity. These latter efforts align with the more elaborate laboratory References testing approaches in a pharmacopoeial 1. Kopp, S. The International Pharmacopoeia monograph or a private specification. – a Myth or Reality? International Pharmacy Journal. 2006, 20 (2). Conclusion Participants at the meeting agreed to 2. Index of Pharmacopoeias at http://www. focus in the future on acceleration of who.int/medicines/areas/quality_safety/ international harmonization between quality_assurance/resources/index-of- pharmacopoeias16032012.pdf. world pharmacopoeias, and also on the establishment of an international bank 3. WHO Medicines Quality Assurance of harmonized texts for substances Programme. Review of World Pharmaco- and finished dosage forms of the most poeias, WHO/QAS/12.512/Rev.1 at http:// common vital medicines. It was also www.who.int/medicines/areas/quality_safety/ agreed that there should be a build-up of quality_assurance/resources/qas frameworks for international information _worldpharmmeeting/en/index.html. exchange among pharmacopoeias, 4. Harmonization – Pharmacopoeial an introduction of new techniques, Discussion Group (PDG) at http://www.usp. org/usp-nf/harmonization

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