International collaboration on GMP inspections

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 facilitates sharing of information on inspection planning and outcomes, and organisation of joint inspections for manufacturing sites of common interest.

For the terms of reference and procedures for the participating authorities, see:

Participating authorities and organisations include:

In April 2018, EMA published a report with an overview of the activities of the programme between 2011 and 2016:

The report shows that the programme has grown both in membership and sites of common interest during this period. The level of information shared between participants has increased and overall inspection coverage grew, benefiting global public health.

The participating authorities concluded that this programme is beneficial and agreed to continue their collaboration. They also made a series of proposals to further streamline day-to-day operations, such as improvements of the electronic platforms for information exchange and regular reviews of the programme deliverables.

The programme started with a pilot in 2008-2010 and became a full programme in January 2011. For more information, see:

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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