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 is responsible for harmonising these standards at EU level. It also coordinates inspections to verify that medicine developers comply with them.
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Medicine developers should also consider the regulatory information in the sections below:
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