QUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES

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1 QUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES Why are Pharmacopoeias so important in a globalised world? Pharmacopoeias have historically provided collections of medical recipes intended to ensure accurate dispensing of medicines by pharmacists. Today, pharmacopoeias play a major role in the regulatory process and the control of active pharmaceutical ingredients (APIs), excipients and drug products and are used by industrial manufacturers, official medicines control laboratories and regulatory authorities. Pharmacopoeias provide public standards, specifications and test methods that are used by independent analysts for quality control. Today more than 80% of APIs used for the production of medicines for the European market come from outside Europe. Harmonised and state-of-the-art European quality standards are crucial to ensure the quality of medicines in this globalised setting. Why the European Pharmacopoeia is beneficial to all The European Pharmacopoeia is used during the life-cycle of a medicine: development, production and commercialisation. It harmonises the quality standards for active pharmaceutical ingredients (APIs), excipients and drug products, which, in their original state or in the form of pharmaceutical preparations, are of general interest and importance to the peoples of Europe, thus contributing to the safe use of medicines. It is constantly evolving either to respond rapidly to new risks to public health (eg: heparin crisis, new safety issues) or to respond to technical and scientific development. It is one of Europe s success stories in the past 50 years, contributing to a harmonised understanding of pharmaceutical quality and as a consequence benefiting all of us whenever we take our medicines Dr Jean Louis Robert, Chair of the European Pharmacopoeia Commission (April 2014). Medicines, Public Health and Media workshop 18 November 2014 Page 1

2 An indispensable reference for the regulatory authorities According to our mission we see ourselves as a national competent authority acting as a partner in the European network and promoting our values, namely being responsible, objective, competent and European. The European Pharmacopoeia serves as a fundamental compendium of quality standards for active substances and excipients; it is appreciated world-wide. The Certification procedure, to which a great many Austrian quality assessors contribute on a routine basis, can be considered as one of the most outstanding work-sharing projects in the field of medicines, ensuring excellent quality of assessment using resources efficiently and thus making a major contribution to public health DI Dr Christa Wirthumer-Hoche, Head of the Austrian Medicines and Medical Devices Agency (AGES) April Who was at the origin of a European Pharmacopoeia? In July 1964, eight countries (Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom) signed the Council of Europe s Convention on the Elaboration of a European Pharmacopoeia. For the first time in their history they undertook to harmonise their national pharmacopoeias and replace their national rules with requirements. The harmonisation of national pharmacopoeias was the first step towards a European regulatory framework for medicines, which today applies to a medicine throughout its development and marketing and sale. What is the exact scope and influence of the European Pharmacopoeia? Today, thirty-seven European countries and the European Union, which in 1994 became a full member alongside its member states, have ratified the Convention, making this instrument's standards legally binding on their territories. The European Pharmacopoeia is also used as a reference by many other countries, both European and non-european. In addition, the European Pharmacopoeia has a growing number of observers, currently comprising 25 countries from all continents, the World Health Organization and the TFDA, and their participation in its scientific work bears witness to its importance and world-wide influence. Observers contribute to the work of the European Pharmacopoeia Commission by participating in scientific discussions but they do not participate in decisions. They may also choose to implement the standards of the European Pharmacopoeia, in full or in part, on their respective territories. This shared success puts Europe at the forefront of public health protection in the pharmaceutical sector. It is an outcome that could not have been achieved without the support of the member Medicines, Public Health and Media workshop 18 November 2014 Page 2

3 countries' national authorities and experts from a wide variety of scientific fields. Health authorities, universities, scientific institutes and industry participate in the work of the European Pharmacopoeia. Thus, for 50 years the European Pharmacopoeia has contributed to the basic human right of access to good quality medicines and healthcare and the promotion and protection of human and animal health. Over these decades, national pharmacopoeias have collaborated and pooled resources to build together a European pharmacopoeia which in 2014 consists of 2600 standard-setting texts published in its 8th Edition. What are the objectives of the European Pharmacopoeia? The European Pharmacopoeia has the objective of preparing quality standards (monographs) for medicines for human or veterinary use and the substances used in their production. The European Pharmacopoeia does not only have to ensure that its standards and test methods are robust and validated but also that they remain state-of-the-art. In addition, it has to respond rapidly to new risks to public health (eg heparin crisis, adverse thromboembolic effects of immunoglobulins etc) by elaborating new methods of analysis and tests and setting new specifications. What are the links between the European Pharmacopoeia and the European Directorate for the Quality of Medicines and HealthCare (EDQM)? The EDQM serves as the technical secretariat to the European Pharmacopoeia Commission. In addition the EDQM is in charge of establishing European Pharmacopoeia reference standards or preparations, which are needed to carry out the tests described in the monographs; The EDQM is also responsible for establishing alternatives to in vivo methods currently prescribed in the European Pharmacopoeia in order to reduce the use of animals (under the Biological Standardisation Programme financed in partnership with the European Commission); Medicines, Public Health and Media workshop 18 November 2014 Page 3

4 In addition the EDQM regularly organises conferences on new scientific and technical subjects, as well as seminars and training sessions on subjects related to the European Pharmacopoeia. What is the role of the European Pharmacopoeia in the pharmaceutical legislation? The European Pharmacopoeia is at the heart of the quality dossier required by European Pharmaceutical legislation, whatever the product's origins, method of production or type. From a simple tablet taken with a glass of water to the most complex types of formulations, all medicines put on the European market must comply with its quality specifications. Quality standards are vital instruments in the context of marketing authorisation and market surveillance; they facilitate access to good quality medicines throughout Europe and beyond. The Convention on the elaboration of a European Pharmacopoeia provides the legal framework for the European Pharmacopoeia and establishes its obligatory nature. The countries that ratify the Convention undertake to contribute to a common pharmacopoeia and to take the necessary measures to ensure that the European Pharmacopoeia texts become the official standards applicable within their respective territories. In addition, the European Pharmacopoeia standards are implemented through Community legislation (directives 2004/28/EC and 2003/63/EC) throughout the countries of the European Economic Area. Therefore consumers and patients can be assured that the medicine they receive, no matter where it was dispensed in Europe, its brand or type, will be safe and of high quality. What are the challenges ahead for the European Pharmacopoeia? Although much of the work on harmonising is almost complete, the quality standards (monographs) need to be continually revised and adopted to keep pace with the changes in the marketplace and scientific advances. There is a continuous need to update monographs, taking account of new developments and requirements triggered by scientific and technical evolutions (e.g. new molecules, new therapies), developments in the regulatory environment (e.g. guidelines like ICH, REACH), increased demand for generic and biosimilar products (e.g. new sources), new risks to public health (e.g. genotoxic impurities, TSE, contamination/falsification (heparins)) and developments in manufacturing and globalisation (e.g. continuous manufacturing, changed routes of synthesis) To remain state-of-the-art, the European Pharmacopoeia has a continuous process for adding and revising quality specifications (in 2014, the 8th Edition of the European Pharmacopoeia comprised over 2600 monographs and general chapters). Globalisation and expansions in international trade present further challenges as there is a growing need to develop global quality standards. Harmonisation among the world s three major pharmacopoeias, the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Medicines, Public Health and Media workshop 18 November 2014 Page 4

5 Pharmacopoeia, is currently an important and challenging task, as these standards are a vital instrument in the registration, market surveillance and free movement and trade of medicines among as many countries as possible. This growth in trade also makes it necessary to extend scientific relations and share expertise with emerging countries such as China, India and Brazil, so that their exports to Europe comply with the strict requirements of the European Pharmacopoeia. What is the origin of the EDQM? The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964) and was established as the Technical Secretariat to the European Pharmacopoeia Commission. Since then the EDQM has been entrusted with additional activities. To support the EDQM member states volunteer not only the services of experts in pharmaceutical sciences and access to equipment in national medicines control laboratories but also the services of experts in blood transfusion, organ transplantation, pharmaceuticals and pharmaceutical care or consumer protection, as well as those involved in assessments and inspections in the context of the certification of suitability procedure. The unwavering support from its member states is one of the factors in the success of the EDQM, enabling it to respond to the needs and realities of public health in Europe and beyond. What is the impact of the European Pharmacopoeia and the EDQM for an Official Medicines Control Laboratory? Defining the quality requirements and exchanging information between laboratories is essential for the success of the surveillance and the control of medicinal products and their ingredients. With the Pharmacopoeia, the EDQM provides the quality requirements and with the OMCL Network, it provides a platform to exchange information on methods and results. Both make my life easier Dr Philippe Girard, Head of Division OMCL (Laboratory), Swissmedic, Switzerland (April 2014) What are the tasks of the Network of Official Medicines Control Laboratories at European level? The network plays an essential role in the organisation of independent quality control testing; it ensures a high degree of control, avoids duplication of work by several countries and allows collaboration between States and facilitates access to state-of-the-art technology and effective analytical procedures. It is a perfect example of work-sharing between member States. Medicines, Public Health and Media workshop 18 November 2014 Page 5

6 2014: 67 official laboratories from 33 countries collaborate in a network, with financial contributions from the European Commission. The added value of the Certification of suitability procedure The Certification of suitability to the European Pharmacopoeia monographs procedure was created to ensure the quality of different sources of pharmaceutical substances in the context of globalisation, while respecting requirements for public health. It includes centralised assessment of applications describing the manufacture and quality control of substances for pharmaceutical use, for the benefit of the regulatory authorities and industry. Its corollary, a programme of inspection of manufacturing sites world-wide, supported by member States, is now an integral part of the procedure. The procedure: - certifies that the quality of substances used in the production of pharmaceutical products is ensured and that these substances comply with the European Pharmacopoeia and therefore with the requirements of the relevant EU legislation - facilitates the management of marketing authorisation applications for medicinal products - ensures work-sharing between licensing authorities and optimises the use of their resources - contributes to work-sharing between inspectorates and optimises the use of scarce resources through close collaboration with European and non-european authorities. The certification procedure provides valuable information on the quality of substances on the world market, which makes it possible to keep the European Pharmacopoeia constantly up to date. What were the EDQM biggest challenges over the last decades? Over the last 50 years, the European Pharmacopoeia and its Secretariat have extended their scope and grown substantially. The Secretariat has become the EDQM, and its portfolio of activities have resulted in what can be considered a true success story in work-sharing and making best use of scarce resources for the benefit of patients. Due to these successes and the experience acquired in international collaboration, the EDQM has been entrusted by the Committee of Ministers of the Council of Europe with additional missions since 2007 so that it is now also responsible for areas activities in the field of blood transfusion, transplantation of organs, cells and tissues, pharmaceuticals and pharmaceutical care and consumer health protection. Medicines, Public Health and Media workshop 18 November 2014 Page 6

7 However, where the quality, efficacy and safety of medicines are concerned, much remains to be done to protect patients health, keep abreast of scientific and therapeutic developments and ensure optimum use of existing resources. This 50th anniversary is an excellent opportunity to thank the member States for their manifold contributions and urge them to continue their collective commitment to public health protection within an intergovernmental paradigm that has proved its worth. Medicines, Public Health and Media workshop 18 November 2014 Page 7