EMA于2026年9月14日更新国际GMP检查协作页面，纳入原料药检查2017至2024年度报告
International collaboration on GMP inspections
EMA更新其国际GMP检查协作页面，纳入覆盖2017至2024年的原料药检查项目报告。报告显示参与机构由10个增至13个，信息共享与协作持续改善GMP监管并减少重复检查，结论与上一份覆盖2011至2016年的报告一致。页面还介绍2019年12月启动的无菌药品境外生产场地检查信息共享试点，疫苗、细胞和基因治疗及血浆制品目前不在该试点范围内。
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.
EMA participates in initiatives with partner organisations outside the EU on good manufacturing practice (GMP) inspections. This helps distribute inspections capacity better, allowing the monitoring of more sites and reducing unnecessary duplication.
For more information on EMA's work in support of good manufacturing practice, see:
Active substance inspections
EMA participates in a programme to rationalise GMP inspections of active substance (active pharmaceutical ingredient) manufacturers at international level.
The aim is to foster cooperation and mutual confidence between participating regulators through better communication.
The programme facilitates:
- exchange of information on inspection planning and outcomes;
- organisation of joint inspections for manufacturing sites of common interest.
Inspection programme reports
The most recent report on the activities of the programme shows that international information sharing and cooperation continue to improve GMP oversight and reduce duplication of inspections.
This report covers the 2017-2024 period. During this time, the programme expanded from 10 to 13 participating authorities.
EMA published this report in September 2026.
Findings are consistent with those from the previous report, which covered the 2011-2016 period. Both reports are available below.
The programme started with a pilot in 2008-2010, becoming established in January 2011. The pilot report is also available.
For more information, see:
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:
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 (TGA);
- 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:
|
| Products excluded |
N/A |
| Scope and territorial applicability |
|
| Exchange of information | Exchange of official GMP documents |
| Agreement | EU-UK Trade and Cooperation Agreement, Annex TBT2 - Medicinal Products |
| Related content |
Page update history
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in September 2026.
14 September 2026
'Active substance inspections' section updated to include information on the 2017-2024 report on the international active pharmaceutical ingredient inspection programme
来源：EMA Inspections · ema.europa.eu