Compliance

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Marketing authorisation holders must comply with standards set out in European Union (EU) directives. The European Medicines Agency (EMA) coordinates inspections to verify this compliance, the results of which are submitted to online databases.

Inspections can be a routine element of a marketing authorisation application or the post-authorisation phase, or they can be requested 'for cause' by the Committee for Medicinal Products for Human Use (CHMP) or a national competent authority. A for cause inspection can be triggered by various factors, such as an assessor’s concern about the validity of data, or a failure to provide all necessary information.

Agency role

EMA’s responsibilities for each inspection area are similar and include:

  • coordinating inspections for the centralised procedure;
  • developing EU-wide guidelines on inspections and related procedures;
  • preparing guidance through inspectors working groups;
  • coordinating advice on the interpretation of requirements. 

Compliance in the product lifecycle

Research and developmentMarketing authorisation applicationPost-authorisation
Quality by design  
Good laboratory practice (GLP) 
Good clinical practice (GCP)
Good manufacturing practice (GMP) and good distribution practice (GDP)
 Pharmacovigilance inspections
 Plasma master files (PMF)
 Sampling and testing
 Vaccine antigen master file (VAMF) inspections
  Mutual recognition agreements

 

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