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Work programme 2017

WC500221614

• Sampling and testing

• Sampling and testing programme. The Agency operates a sampling and testing programme to supervise the quality of centrally authorised medicinal products placed on the market and to check compliance of these products with their authorised specifications. Sampling from the market in different Member States is carried out by national inspectorates and testing is performed by Official Medicines Control Laboratories (OMCL), coordinated through the European Directorate for the Quality of Medicines and Healthcare (EDQM). The Agency is responsible for the selection of products to be sampled and the follow-up of any findings with the relevant marketing-authorisation holders and rapporteurs. • Certificates. The Agency issues certificates of medicinal products, in accordance with WHO requirements, in order to support the work of health authorities outside the European Union, especially in developing countries. Certificates are issued by the Agency, on behalf of the European Commission, to confirm the marketing-authorisation status and GMP compliance of the manufacturing sites of products authorised by the Commission through the centralised procedure, or of products for which a marketing-authorisation application has been submitted to the Agency. • Parallel distribution. Parallel distribution is the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company, independent of the marketing-authorisation holder. The Agency checks compliance of products distributed in parallel with the conditions laid down in Union legislation on medicinal products and the marketing authorisation of the product. • Mitigation of supply shortages. Past years saw cases of global supply shortages of medicines caused by quality defects or GMP non-compliance. This has led to development of recommendations to minimise the risks of such shortages occurring in the future, as well as mitigate the impact of shortages that do occur. The Agency continues to promote proactive riskmanagement by manufacturers and marketing-authorisation holders and, within its scope, instilling controls to ensure product quality and supply continuity. Drivers Increasing numbers of manufacturing sites located and clinical trials conducted outside the EU will continue to be a trend. As a result, increased focus on ensuring the medicines tested and manufactured outside the EU meet the EU requirements will drive efforts to develop and strengthen collaboration with international partners regarding collaborative inspections, information exchange, capacity-building and greater mutual reliance. Increasing complexity and globalisation of the medicines supply chain will also contribute to information exchange and closer, more streamlined cooperation among authorities, to ensure product and data integrity, and continuity of the medicines supply chain. Parallel distribution is seeing increase across the three procedures – initial notifications, annual updates and notifications of change. The increase in notifications of change is driven by the growing number of safety updates to centrally authorised products. There is a slight year-on-year increase in number of certificates for medicinal products issued, which reflects the overall increase in marketing authorisations of centrally authorised products. The forecasts for the number of inspections do not account for the additional GCP and GMP inspection coverage that the Agency aims to attain through information exchange on inspections performed by other non-EU authorities. Work programme 2017 EMA/583016/2016 Page 84/123

Workload indicators Results Forecasts 2014 2015 2016 2017 GMP inspections 420 2 567 2 548 200 GLP inspections 0 1 0 1 GCP inspections 66 86 121 125 Pharmacovigilance inspections 20 14 8 14 PMF inspections - 3 - 3 124 45 Notifications of suspected quality defects 147 164 181 200 Notifications of GMP non-compliances 1 18 17 60 Medicinal products included in the sampling and testing programme 46 48 48 48 Standard certificate requests received 3,338 3,221 3,787 3,500 Urgent certificate requests received 535 785 487 480 Parallel distribution initial notifications received 2,492 2,838 2,850 3,350 Parallel distribution notifications of change received 1,295 2,096 1,847 2,200 Parallel distribution notifications of bulk changes received 9 13 8 11 Parallel distribution annual updates received 2,339 4,550 4 3,815 5 5,100 1 previously: "Other GMP inspections related notifications" 2 includes PMF inspections 3 included in GMP inspections results 4 includes 560 parallel distribution annual update notifications that were received in 2014 but processed in 2015 5 excludes approximately 1000 notifications received but not processed in 2016 Performance indicators Results Targets 2014 2015 2016 2017 Inspections conducted within established regulatory 100% 100% 100% 100% timeframes Standard certificates issued within established timelines (10 30.4% 91% 91.6% 90% working days) Average days to issue standard certificate 13.7 7 7 10 Urgent certificates issued within established timelines (2 100% 100% 100% 100% working days) Parallel-distribution notifications checked for compliance 97% 99% 99% 90% within the established timeline Additional GCP inspections addressed through information 29% 46% 34% 35% exchange on inspections carried out by international partners Additional routine GMP re-inspections of manufacturing sites 8% 14% 19% 10% addressed through exchange of information with international partners Outcome reports of the Sampling and Testing for centrally authorised products followed up with the MAH within one month of receipt 100% 100% 100% 100% Work programme 2017 EMA/583016/2016 Page 85/123

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