EMA role in GMP Manufacturing and Quality Compliance

Transcription

1 EMA role in GMP Manufacturing and Quality Compliance III all Russian GMP Conference Kazan 2018, Russia Presented by Roberto Conocchia Manufacturing and Quality Compliance European Medicines Agency An agency of the European Union

2 Contents Introduction EMA role in GMPs GMP Inspections Mutual recognition agreements agreements Quality defects and recalls Sampling and testing Conclusion 1

3 EU Network - EMA 28 EU member states + 3 EEA members states (~500 million citizens) 50 National Regulatory Authorities 4,500 European experts EMA - Decentralised agency of the EU - founded in Located in London, ~890 staff 2

4 EMA role in Manufacturing and Quality Compliance EMA is a technical, scientific and administrative secretariat Co-ordination of GMP inspections Developing and maintaining the EudraGMDP database GMP/GDP Inspectors Working Group Developing EU-wide procedures on GMP inspections and related activities (Compilation of Union procedures) Sampling and Testing planning for Centrally Authorised Products (CAPs) Coordination of the actions at EU level in case of Quality Defects, Shortages and counterfeited products 3

5 Co-ordination of GMP inspections Each member state is responsible for inspecting manufacturing sites located within their own territories. Manufacturing sites outside the EU are inspected by the national competent authority of the Member State where the EU importer is located. EMA facilitates cooperation between the authorities concerned in supervising the sites. EU competent authorities plan routine inspections following a risk-based approach, or if there is suspicion of non-compliance 4

6 Co-ordination of GMP inspections Summary of GMP inspections performed by EU inspectorates (1) USA CHINA INDIA RW EU 5 Source: EudraGMDP data 9 th January 2018

7 Co-ordination of GMP inspections Summary of GMP inspections performed by EU inspectorates with SNC (2) USA CHINA INDIA RW EU 6 Source: EudraGMDP data 9 th January 2018

8 Co-ordination of GMP inspections Summary of GMP inspections performed in Russia by EU inspectorates (2) GMP inspections in Russia number of gmp inspections No statement of noncompliance with GMP has been issued 7 Source: EudraGMDP data 24 th May 2018

9 EudraGMDP database EudraGMDP is a publicly accessible EU database which contains manufacturing and import authorisations, registration of active substance manufacturers, GMP certificates and non-compliance statements. After inspecting a manufacturing site, EU competent authorities issue a GMP certificate or a non-compliance statement, which is entered in the EudraGMDP database. In April 2013, the Agency launched a further module, extending coverage to GDP-related information and registration of manufacturers, importers and distributors of active substances 8

10 GMP/GDP Inspectors Working Group EMA chairs and provides the secretariat for the GMP/GDP Inspectors Working Group of senior inspectors appointed by all the EEA competent authorities. It meets at EMA four times a year. The group provides a forum for harmonisation and discussion of common issues, such as: updates or amendments to the EU GMP guidelines; the compilation of Union procedures; harmonised interpretation of GMP and related requirements. 9

11 Compilation of Union procedures EMA maintains a compilation of GMP and good distribution practice (GDP) inspection-related procedures and forms agreed by all Member States. This facilitates cooperation between EU Member States and supports harmonisation and exchange of inspection-related information. eline/2009/10/wc pdf 10

12 Mutual recognition agreements The EU has signed mutual recognition agreements on GMP inspections with regulatory authorities outside the EU. This allows EU authorities and their counterparts to: 1) rely on each other's GMP inspections; 2) waive batch testing of products on entry into their territories; 3) share information on inspections and quality defects. Mutual Recognition Agreements in place: al/general_content_ jsp&mid=wc0b01ac058005f8ac 11

13 Mutual recognition agreements (2) EMA is involved in operational activities once the MRAs are in place, including: facilitating cooperation on inspections, including joint inspections and exchange of information on inspections; facilitating exchange of information and relevant contact points between the EU GMP inspectorates and partners countries; operating the EudraGMPD Database and connecting partners countries to it; responding to queries on the implementation of the MRA; involving partner countries in relevant EMA working groups, such as the GMP/GDP working group; coordinating MRA maintenance activities 12

14 International collaboration on GMP inspections (1) EDQM - sampling and testing programme for CAPs - collaboration on coordination of API inspections WHO - optimisation of the use of inspection resources - capacity building - promoting the adoption of EU regulatory approaches PIC/S (Pharmaceutical Inspection Co-operation Scheme ) formal agreement between EMA and PIC/S to collaborate to maintain common GMP guideline at international level - aim to better use inspection resources, avoid duplication of activities - aim to maintain mutual confidence and promote quality assurance of inspections 13

15 International collaboration on GMP inspections (2) ICMRA (International Coalition of Medicines Regulatory Authorities) - forum to support international cooperation among medicines regulatory authorities - completed a procedure for mutual recognition of GMP inspections ICH to support the EU constituency in developing guidelines with particular attention on GMP inspection and pharmaceutical quality systems approach 14

16 Quality defects and recalls The European Medicines Agency (EMA) coordinates the assessment of reports of product quality defects of centrally authorised medicines. EMA has a coordinating role between the marketing authorisation holder, the rapporteur(s) responsible for the product at EMA's relevant scientific committee, the supervisory authority and the national competent authorities where the product is marketed. If the nature of a product quality defect of a medicinal product presents a serious risk to public and animal health, national competent authorities inform each other through the rapid alert system.

17 Sampling and testing The European Medicines Agency implements every year a sampling and testing programme, aimed at supervising the quality of the Centrally Authorised Products (CAPs) available on the European market. Annual reports on the outcome of the sampling and testing programme have been published starting with products submitted for testing in 2003.

18 Conclusion The coordination of GMP inspections can save resources and share competencies within the EU network. The EMA coordination of quality defects and recalls is helpful in order to have a common decision in whole the EU network. The EMA responsibility to co-ordinate the sampling and testing program is an important role for the supervision of centrally authorised medicinal products. Despite the challenges and the big changes coming in the next future, EMA will continue to deliver on its mission and protect public and animal health and make every effort to avoid any issues of centrally authorised medicinal products. 17

19 Any Questions? European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website Follow us 18