International collaboration on GMP inspections

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With the increasing globalisation of medicine manufacturing and supply chains, regulatory authorities across the world need to cooperate in the overall interest of public health. The European Medicines Agency (EMA) participates in initiatives with partner organisations outside the European Union (EU) on good manufacturing practice (GMP) inspections, in order to better distribute inspections capacity, allowing more sites to be monitored and reducing unnecessary duplication.

Active substance inspections

EMA participates in a programme to rationalise GMP inspections of active substance manufacturers at international level. The aim is to foster cooperation and mutual confidence between participating regulators through better communication and exchange of information on inspections.

The programme includes sharing of information on inspection planning, policies and inspection reports, and organisation of joint inspections in case where a manufacturing site is of interest for more than one of the participating authorities:

Participating authorities include:

This collaboration is not linked to the EU Falsified Medicines Directive, which adds specific rules on the import of active substances into the EU. 

Drug shortages due to GMP non-compliance and quality defects

EMA participates in quarterly teleconferences on drug shortages due to GMP non-compliance and quality defects since 2013. 

The aim of this interaction is to develop international co-operation to share information on specific shortages (with or without impact on other territories) and best practices on risk management and prevention strategies.

Participating authorities include:

EMA/FDA cooperation

EMA and FDA ran a joint inspection programme on finished-dosage-form manufacturers and an initiative to share work on inspections of manufacturing sites before signing a mutual recognition agreement (MRA) in 2017.

These bilateral collaborative activities contributed to building trust and increase confidence in each other’s activities, allowing the MRA to be fully implemented.

For more information, see:

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