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 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:
- EU Member States (France, Denmark, Ireland and Italy);
- the United Kingdom’s Medicines and Healthcare products Regulatory Authority (MHRA);
- the European Directorate of the Quality of Medicines and Healthcare (EDQM);
- the United States Food and Drug Administration (FDA);
- the Australian Therapeutic Goods Administration (TGA);
- Health Canada (from December 2015);
- the Japanese PMDA (from December 2016)
- the World Health Organization (WHO).
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.
Manufacturers of sterile medicines
In December 2019, EMA and its European and international partners launched a pilot programme to share information on GMP inspections of manufacturers of sterile medicines located outside the participating countries and to organise joint inspections of manufacturing sites of common interest.
The products in scope include sterile medicines for human use of chemical origin and certain therapeutic biotechnology-derived products, such as monoclonal antibodies and recombinant proteins.
Vaccines, cell and gene therapies and plasma-derived pharmaceuticals are currently out of the scope of this pilot.
For the terms of reference, objectives and full scope, see:
Participating authorities and organisations include:
- EU Member States (France);
- the United Kingdom’s Medicines and Healthcare products Regulatory Authority (MHRA);
- the United States Food and Drug Administration (FDA);
- the Australian Therapeutic Goods Administration (TGA);
- Health Canada;
- the Japanese PMDA;
- the World Health Organization (WHO).
The pilot will last for a minimum of two years. After this period, participating authorities will assess the programme and determine the next steps.
This initiative builds on the success and experience with the international active substance inspection programme.
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:
- the United States Food and Drug Administration (FDA);
- the Australian Therapeutic Goods Administration;
- Health Canada.
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:
EU-UK cooperation
EMA collaborates with the UK as per the EU-UK Trade and Cooperation Agreement, Annex TBT2 - Medicinal Products.
Under the agreement, the EU and UK recognise the outcomes of GMP inspections carried out by the other party in their territories and may also recognise the outcomes of inspections carried out in other third countries.
Recognition of GMP inspection outcomes under the EU-UK Trade and Cooperation Agreement
| Status | In provisional application since 1 January 2021 as 'Annex TBT-2: Medicinal Products' to the Trade and Cooperation Agreement between the EU and UK |
| Products covered | Medicinal products for human use and veterinary use:
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| Products excluded | N/A |
| Scope and territorial applicability |
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| Exchange of information | Exchange of official GMP documents |
| Agreement | EU-UK Trade and Cooperation Agreement, Annex TBT2 - Medicinal Products |
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