Compliance: research and development

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Medicine developers are responsible for ensuring that they and any parties working for them comply with standards set out in European Union (EU) legislation and guidelines for good clinical practice (GCP), good laboratory practice (GLP) and good manufacturing practice (GMP) for investigational medicinal products.

The European Medicines Agency (EMA) is responsible for harmonising these standards at EU level. It also coordinates inspections to verify that medicine developers comply with them.  

United Kingdom’s (UK) withdrawal from the EU

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK’s withdrawal from the EU.

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Medicine developers should also consider the regulatory information in the sections below:

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