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CHAPTER 2 - KEY FIGURES IN 2019

Inspections and compliance

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EMA coordinates the verification of compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), good pharmacovigilance practices (GVP) and certain aspects of the supervision of authorised medicines in the EU. Here are some key figures for inspections in 2019. For more detailed information, download the full annual report 2019 (PDF version).

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GMP - GOOD MANUFACTURING PRACTICE

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497 GMP inspections requested by EEA authorities in 2019
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2262 certificates and 16 non-compliance statements issued by EEA authorities
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GCP - GOOD CLINICAL PRACTICE

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137 GCP inspections requested in 2019
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605 GCP inspections finalised by EEA authorities in 2019
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PHARMACOVIGILANCE INSPECTIONS & MARKET SURVEILLANCE

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9 Pharmacovigilance inspections requested by the CHMP or the CVMP
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175 suspected quality defect notifications received by EMA