| Research and development | Marketing authorisation application | Post-authorisation |
| Good laboratory practice (GLP) | ||
| Good clinical practice (GCP) | ||
| Good manufacturing practice (GMP) | ||
| Pharmacovigilance inspections | ||
| Sampling and testing | ||
| Good distribution practice (GDP) | ||
| Quality defects and recalls | ||
| Falsified medicines: reporting obligations |
EMA coordinates inspections for human and veterinary medicines authorised under the centralised procedure or in the context of a referral, on request from the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP).
EMA does not conduct inspections itself but requests that the inspection be carried out by national authorities in the EU Member States.
EMA is the primary contact point for reporting a suspected quality defect with any centrally authorised product and is responsible for coordinating the investigation, evaluation and follow-up of such cases.
EMA also operates a Sampling and testing programme to verify the quality of centrally authorised medicines placed on the market and to check their compliance with their authorised specifications.
In addition, EMA plays a key role is in coordinating and harmonising EU-wide activities, including:
Authorities in the EU regularly inspect sites within and outside the EU involved in developing, manufacturing and distributing human or veterinary medicines intended for the EU market, to verify their compliance with the relevant standards.
These inspections ensure that the rights, safety and wellbeing of clinical-trial subjects are protected, and the reliability and integrity of data that support the authorisation of medicines and their quality, safety and effectiveness once on the market.
An inspection may either be 'for cause', when it is triggered by a finding of possible non-compliance with relevant standards, or routine, when inspections are carried out as part of a surveillance programme.
Inspections are conducted both for authorised medicines and for medicines under evaluation in the EU.
An overview of the different types of inspection EMA's CHMP can request as part of the assessment and monitoring of human medicines under the centralised authorisation procedure is available below.
| Why compliance matters | Provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical trial data are credible |
| Purpose of inspections | Confirms that clinical trials supporting a marketing authorisation application are conducted in line with GCP standards and all relevant legal and regulatory requirements in the EU |
| Sites in scope | Any site where clinical trials that are part of an application are carried out, no matter where in the world it is located |
| When they occur | EMA's CHMP can request a GCP inspection at any stage in the evaluation of a medicine. The evaluation of the need for a GCP inspection is a routine part of this process. For more information, see: |
| Impact of adverse outcomes | If a GCP inspection reports critical or major findings on the conduct of clinical trials supporting a marketing authorisation application:
|
| Publicly available information | Each medicine's assessment report includes information on the:
For the latest statistics on GCP inspections requested by the CHMP, see Annual reports. |
| International cooperation | If the clinical trials took place outside the EU, and if EMA has a confidentiality arrangement with the responsible non-EU regulator, the two jurisdictions may:
For more information see International agreements. |
| More information | |
| Related materials | Visual guide: GCP inspections requested by the CHMP between 1997 and 2019 Infographic on the 1,000 GCP inspections requested by the CHMP |
| Why compliance matters | Provides public assurance that medicines on the EU market are of consistently high quality, appropriate for their intended use and meet the requirements of the marketing authorisation or clinical trial authorisation |
Purpose of inspections | Confirms that any medicine intended for the EU market is manufactured in compliance with GMP standards and all relevant legal and regulatory requirements in the EU |
| Sites in scope |
For more information see: |
| When they occur | EMA's CHMP can request a GMP inspection at any time during a medicine's evaluation or after a medicine is authorised in the EU. For more information, see: |
| Impact of adverse outcomes | If a GMP inspection leads to adverse findings, the company must implement a corrective action plan agreed with the inspectors |
| Publicly available information | The EudraGMDP database holds the data collected during GMP inspections by EU authorities, including those requested by the CHMP. Each medicine's assessment report includes information on the:
For the latest statistics on GMP inspections requested by the CHMP see Annual reports. |
| International cooperation | If a medicine is manufactured outside the EU, and if the EU has a mutual recognition agreement (MRA) with the country in question on the conformity assessment of regulated products, the two jurisdictions can:
EMA also takes part in international initiatives to:
For more information see: |
| More information |
|
| Why compliance matters | Provides public assurance that the validity, integrity and reliability of non-clinical safety, toxicological and pharmacological data submitted for regulatory evaluation and approval are credible |
| Purpose of inspections | Confirms that non-clinical studies supporting a marketing authorisation application are conducted in compliance with GLP standards and all relevant legal and regulatory requirements in the EU |
| Sites in scope | Any site where pivotal non-clinical studies are carried out, no matter where in the world it is located |
| When they occur | EMA's CHMP can request a GLP inspection at any stage in the evaluation of a marketing authorisation application. For more information, see: |
| Impact of adverse findings | If inspectors report critical or major findings on the conduct of non-clinical studies, the CHMP evaluates the impact on the medicine’s benefit-risk balance. |
| Publicly available information | Each medicine's assessment report includes information on the:
|
| International cooperation | If the non-clinical studies took place outside the EU, and if EMA has a confidentiality arrangement with the responsible non-EU regulator, the two jurisdictions may:
The EU is a signatory to the OECD mutual acceptance of data (MAD) agreement, which allows participating authorities to rely on each other's monitoring programmes for GLP compliance. |
| More information |
| Why compliance matters | Provides public assurance that marketing authorisation holders, or third parties acting on their behalf, have adequate systems in place for the safety monitoring of medicines on the EU market |
| Purpose of inspections | Confirms that the marketing authorisation holder has personnel, systems and facilities to meet their pharmacovigilance obligations |
| Sites in scope | Any party carrying out pharmacovigilance activities in whole or in part, on behalf of or in conjunction with, the marketing authorisation holder, no matter where in the world it is located |
| When they occur | EMA's CHMP can request a pharmcovigilance inspection at any stage during the evaluation of a marketing authorisation application or after a medicine is authorised. For more information, see: |
| International cooperation | EMA can exchange information on pharmacovigilance inspection findings with non-EU regulators with which EMA has signed a confidentiality arrangement. For more information see International agreements. |
| More information |
For more information on the authorisation of medicines in the EU, see: