EMEA European Medicines Agency

1. EMEAEuropean Medicines Agency Presented by: Aarohi Shah M. Pharm: L.M.C.P. Department of Pharmaceutics and Pharmaceutical Technology

2. Structure • The EMEA began its activities in 1995. • Decentralised body of the European Union - headquarters in London. • 25 EU Member States in a network of 42 national competent authorities • Aim: Protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use • Coordinates the evaluation and supervision of medicinal products throughout the European Union. • Centralised procedure - one single marketing authorisation application • If the relevant Committee concludes that quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. • This is sent to the Commission to be transformed into a single market authorisation valid for the whole of the European Union.

3. EMEA Mission Statement • Developing efficient and transparent procedures • Controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals, • Facilitating innovation and stimulating research • Mobilising and coordinating scientific resources from throughout the EU to provide high-quality evaluation of medicinal products • To advise on research and development programmes • To perform inspections • To provide useful and clear information to users and healthcare professionals.

4. Organigramme

5. Management Board • A Chairman • Two members of European parliament European commission • Two representatives of Patients' organizations Doctors' organizations Veterinarians' organizations • One representative of each member country • One representative of observer countries

6. 25 Member countries • Austria • Belgium • Cyprus • Czech Republic • Denmark • Estonia • Finland • France • Germany • Greece • Hungary • Ireland • Italy • Latvia • Lithuania • Luxembourg • Malta • Netherlands • Poland • Portugal • Slovakia • Slovenia • Spain • Sweden • United Kingdom

7. Observer countries (EEA-EFTA States) • Bulgaria • Iceland • Liechtenstein • Norway • Romania

8. EMEA Committees Committee for Medicinal Products for Human Use (CHMP) The CHMP is composed of • A chairman, elected by serving CHMP members • One member (and an alternate) nominated by each of the 25 EU Member States • One member (and an alternate) nominated by each of the EEA-EFTA states Iceland and Norway • Up to five co-opted members, chosen among experts nominated by Member States or the EMEA and recruited, when necessary, to gain additional expertise in a particular scientific area.

9. EMEA Committees Committee for Medicinal Products for Human Use (CHMP) Role and responsibilities • Assessment of medicinal products for which a Community-wide marketing authorisation is sought • Responsible for several post-authorisation and maintenance activities • Arbitrates in cases where there is a disagreement between Member States concerning the marketing authorisation of a particular medicinal product • Assessments conducted by the CHMP are based on purely scientific criteria • These processes ensure that medicinal products have a positive risk-benefit balance • The CHMP plays an important role in this EU-wide ‘pharmacovigilance’ activity by closely monitoring reports of adverse drug reaction reports, making recommendations regarding changes to a product’s marketing authorisation or the product’s suspension/withdrawal from the market. • Can issue an ‘urgent safety restriction’ (USR) • The CHMP publishes a European Public Assessment Report (EPAR) for every centrally authorised product that is granted a marketing authorization The EMEA’s integrated quality-management system ensures effective planning, operation and control of the CHMP’s processes and records.

10. EMEA Committees Committee for Medicinal Products for Veterinary Use (CVMP) • The CVMP composition • Roles and responsibilities

11. EMEA Committees Committee for Orphan Medicinal Products (COMP) The COMP is composed of • A chairman, elected by serving COMP members; • One member nominated by each of the 25 EU Member States; • One member nominated by each of the EEA-EFTA states (Iceland, Liechtenstein and Norway) • Three members nominated by the European Commission To represent patients' organisations On the EMEA's recommendation • One European Commission representative • General observers

12. EMEA Committees Committee for Orphan Medicinal Products (COMP) Role and responsibilities • The Committee for Orphan Medicinal Products (COMP) is responsible for reviewing applications from persons or companies seeking 'orphan medicinal product designation' for products they intend to develop for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union. • The COMP is also responsible for advising the European Commission on the establishment and development of a policy on orphan medicinal products in the EU.

13. EMEA Committees Committee on Herbal Medicinal Products (HMPC) Composition • One member and one alternate member from each of the EU Member States and EEA-EFTA states. • The HMPC is composed of scientific experts in the field of herbal medicinal products. • Currently, the Committee has co-opted members with expertise in clinical pharmacology, experimental/non-clinical pharmacology, toxicology and paediatric medicines. A member with expertise in traditional herbal medicines may be co-opted in 2006

14. EMEA Committees Committee on Herbal Medicinal Products (HMPC) Role and responsibilities • Assisting the harmonisation of procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further integrating herbal medicinal products in the European regulatory framework. • Provides EU Member States and European institutions its scientific opinion on questions relating to herbal medicinal products

15. Product information Human Medicines Veterinary Medicines Safety Announcements Product Withdrawals Summary of Opinions Opinions for Orphan Designation Opinions for medicines used outside the EU

16. EMEA Interaction with Patients' and Consumers' Organisations • Agency together with the EMEA/CHMP Working Group with Patients' Organisations prepared a set of criteria to be fulfilled by patients’ and consumers’ organisations prior to involvement in the EMEA activities. • Based on these criteria, a questionnaire has been prepared to collect all necessary information in order to evaluate if your organisation fulfils the defined criteria, and therefore can be involved in EMEA activities. • One can contact EMEA through this e-mail ID: patients-consumers@emea.eu.int

17. SME Office: Addressing the needs of small and medium-sized enterprises (SMEs) • Specific provisions aimed at promoting innovation and the development of new medicinal products for human and veterinary use by SMEs were adopted by the European Commission on 15 December 2005. • The Agency has launched an 'SME Office', which is dedicated to addressing the particular needs of smaller companies. • Any queries, feedback or comments are welcome. • Contact point smeoffice@emea.eu.int

18. Inspections - Activities of the Sector • Coordination of the verification of compliance with the principles of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) • Co-ordinating any inspection requested by the CHMP or CVMP • Pharmacovigilance (PhV) • Vaccine Antigen Master File (VAMF) and Plasma Master File (PMF) certification. • The Sector organises and chairs regular meetings ofEuropean Economic Area (EEA) GCP and GMP inspectors • Implications of PAT • Sampling and Testing Programme. • Communication and action by Member States in response to suspected Quality Defects • Responsibility for issuing Certificates of Medicinal Products in accordance with WHO requirements Whilst most scientific activities of the Agency are divided between medicinal products for human and for veterinary use, the tasks of the Inspections Sector are typically common to both types of products.

19. Inspections EMEA Certificates of Medicinal Products • The EMEA certification scheme is based on World Health Organisation recommendations • EMEA Certificates are issued by EMEA, on behalf of the European Commission, to confirm the Marketing Authorisation status of products • EMEA issues certificates within 10 working days following receipt of a valid application form.

20. Inspections Counterfeit Medicines • Counterfeit medicines are substandard pharmaceuticals - medicines manufactured below established standards of safety, quality and efficacy. • Counterfeiting can apply to both branded and generic products • Counterfeit medicines may include products with Correct ingredients but fake packaging with the wrong ingredients without active ingredients with insufficient active ingredients. • The most frequently counterfeited medicines in wealthy countries developing countries • As the phenomenon spreads, more and more medicines are counterfeited, including expensive ones, such as anti-cancer drugs, and those highly in demand, such as antivirals. • EMEA seeks to support anti-counterfeiting activities in close cooperation with the Commission and national medicines agencies by facilitating information sharing and coordinating actions (including recalls and testing)

21. Inspections Good Clinical Practice - Human Medicinal Products • Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. • Clinical trials included in any marketing authorisation application in the EU are required to be conducted in accordance with GCP • The sector is involved in the preparation of new and revised guidance on GCP topics, co-ordination of advice on the interpretation of EU GCP requirements and related technical issues, and on the development of community-wide procedures relating to GCP inspections. • Europe has adopted the ICH-GCP in July 1996

22. Inspections Good Clinical Practice - veterinary medicinal products • For clinical trials of veterinary products, Europe has adopted the VICH GCP • It provides guidance on the design and conduct of all clinical studies of veterinary products in the target species. • It is directed at all individuals and organisations involved in the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies in target species and is intended to ensure that such studies are conducted and documented in accordance with the principles of Good Clinical Practice (GCP).

23. Inspections Good Laboratory Practice • The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived. • The Procedure describes the co-ordination of GLP inspections of the non-clinical safety, toxicological and pharmacological studies proposed in human and veterinary applications for marketing authorisations under the centralised system. • EMEA Inspections Sector has advised the CHMP and CVMP that pivotal studies for centralised products should be inspected to assess their compliance with the Principles of GLP.

24. Inspections Good Manufacturing Practice • Good Manufacturing Practice (GMP) is defined as “That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.” • The principles and guidelines for GMP are stated in two Directives; Directive for medicinal products and investigational medicinal products for human use and Directive concerning veterinary medicinal products

25. Inspections Process Analytical Technology • The term "Process Analytical Technologies (PAT)" has been used to describe "a system for designing and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes for raw and in-process materials and also processes with the goal of ensuring final product quality". • Focused on a comprehensive analysis of the active substance, the choice of the composition, the manufacturing method, as well as the identification of the critical process parameters and the development of suitable analytical methods • In order to support the PAT activities in EU, an EMEA PAT team was created in November 2003. • Aim to review the implications of PAT and to ensure that the European regulatory framework and the authorities are prepared for and adequately equipped to conduct thorough and effective evaluations of PAT-based submissions.

26. Inspections Product Defects and Recalls • In order to protect public health and animal health, it may become necessary to implement urgent measures such as the recall of one or more defective batch(es) of a medicinal product during its marketing period. • The authorisation holder is required to notify the relevant Competent Authority of any defect or abnormal restriction that could result in a recall. • Competent Authorites should ensure that information concerning the recall of medicinal products is notified rapidly to other Member States, if the nature of the defect presents a serious risk to public health. • This information is communicated using the Rapid Alert Procedure

27. Inspections Sampling and Testing of Centrally Authorised Products • The EMEA implements every year a sampling and testing programme, aimed at supervising the quality of the Centrally Authorised Products (CAPs) available on the European market. • EMEA is supported by other institutional partners and by the marketing authorisation holders; each of these plays an important role in the success of the programmes. • Annual reports on the outcome of the sampling and testing programme have been published starting with products submitted for testing in 2003.

28. Inspections Inspection Fees • An applicant for a marketing authorisation under the centralised procedure (or for a variation to an existing marketing authorisation) is liable to pay a fee for each inspection. • A separate, full inspection fee of €17,400 is charged for each distinct inspection of an individual site and €8,700 in the case of consecutive distinct inspections. • Invoices are issued within 20 days of the confirmation of the inspection dates by the relevant inspectors and are sent by registered post to the applicant. • To pay the total fee charged within 45 days from the date on which the inspection is carried out. • For inspections outside the Community the applicant is also required to pay the travel and accommodation expenses of the Inspector(s) and any Experts involved in carrying out the inspection(s). These expenses are to be paid directly by the applicant to the inspectors’ Authorities.

29. Recruitment • Recruitment Policy • Job Opportunities

30. Recruitment This section gives detailed information for the selection of various members of working committees. • Eligibility • Experience • Linguistic requirements • Application form • Selection procedures • Data protection • Appeal procedure • Reserve list and requirements • Recruitment policies

31. Meetings & events... • EMEA Calendar • Conferences & Events

32. EU Enlargement • The EMEA has opened up a new area for this topic with a view to providing information and guidance to applicants and marketing authorization holders during the run up to accession of Bulgaria and Romania as of 1st January 2007 and future candidate countries. • The intention is to provide a variety of information on topics specific to the EMEA’s activities and help applicants/marketing authorization holders prepare for those phasing in processes and transitional processes.

33. EMEA Implementation of the New EU Pharmaceutical Legislation These new provisions provide tools to speed up patients’ and healthcare professionals’ access to medicinal products in the Community. They also introduce measures for better safety monitoring of medicinal products for human and veterinary use

34. EMEA Implementation of the New EU Pharmaceutical Legislation New name for the EMEA • As a consequence of the revised EU pharmaceutical legislation, the name of the EMEA changed from the 'European Agency for the Evaluation of Medicinal Products' to the 'European Medicines Agency'. • The acronym 'EMEA', however, remains unchanged.

35. EMEA Implementation of the New EU Pharmaceutical Legislation New composition of the Management Board • Previously there were two representatives per Member State on the Board, there is now only one. • Board will include two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations. The selection process for these representatives is ongoing; it is expected that the full composition of the Board will be settled shortly. • Management Board continues to have two representatives of the European Parliament and two representatives of the European Commission, plus one observer from each of the EEA-EFTA states Iceland, Liechtenstein and Norway. • Each member of the Management Board has an alternate.

36. EMEA Implementation of the New EU Pharmaceutical Legislation New composition of CHMP and CVMP • Now have one representative per EU Member Stateinstead of two, plus one representative for Iceland and one representative for Norway. • Each committee member has an alternate. • Possibility of appointing up to five co-opted members each, to gain additional expertise in particular scientific areas.

37. EMEA Implementation of the New EU Pharmaceutical Legislation New scientific committee: HMPC • The HMPC was inaugurated in September 2004. • The role of the HMPC is to provide the Member States and the European Institutions with the best-possible scientific opinions on questions relating to herbal medicinal products.

38. EMEA Implementation of the New EU Pharmaceutical Legislation New scientific advice working parties (SAWPs) • Providing scientific advice to undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products. • The CHMP and CVMP have each set up a Scientific Advice Working Party to fulfil this responsibility by providing scientific advice and protocol assistance to sponsors, companies, research institutes, etc.

39. EMEA Implementation of the New EU Pharmaceutical Legislation New scientific advisory groups (SAGs) • On request from the committee concerned, an independent recommendation on scientific and technical matters relating to products under evaluation. • Views expressed by the SAGs are taken into account, the ultimate responsibility for final opinions rests with the respective scientific committee. • SAGs to provide expertise on oncology, diagnostics, anti-infectives and endocrinology/diabetes. The establishment of SAGs for HIV/viral diseases, CNS/psychiatry, and cardiology is planned for 2005/2006.

40. EMEA Road Map to 2010 • European Medicines Agency (EMEA) has developed a long-term strategy that will contribute to better protection and promotion of public and animal health, improve the regulatory environment for medicinal products, and help to stimulate innovation, research and development in the EU. • The Road Map takes a realistic view of the challenges facing the Agency and the EU regulatory system as a whole, while offering viable proposals as to how those challenges can be met. • On the solid achievements of the past 10 years, the EMEA and its partners in the EU medicines system adequately prepared theground for further success in the years to come.

41. Contacting the EMEA... EMEA7 Westferry CircusCanary WharfLondonE14 4HBUnited KingdomTelephone switchboard:(44-20)74 18 84 00 Web site: www.emea.eu.int

42. Contacting the EMEA by e-mail... General enquiries: info@emea.eu.int Press enquiries: press@emea.eu.int E-mail addresses for EMEA staff members are constructed as follows: first-name.family-name@emea.eu.int

43. REFERENCE • http://www.emea.eu.int/

44. THANK YOU