Sampling and testing
HumanVeterinaryCompliance and inspections
This content applies to human and veterinary medicines.
The European Medicines Agency (EMA) supervises the quality of the centrally authorised medicines available on the European market through its yearly sampling and testing programme.
The main objective of the sampling and testing programme is to check the compliance of products on the market with their authorised specifications. This involves:
- monitoring the quality of the finished products in all parts of the distribution chain throughout the authorised shelf-life;
- ensuring that control methods are satisfactory;
- investigating suspected quality defects (if required);
- assisting with the testing of falsified medicines (if required).
For more information, see:
EMA will extend its sampling and testing programme from 2019. As part of the new sampling and testing activities, it will:
- expand the generics programme by increasing the coverage of market surveillance through synergies with national sampling and testing programmes for products authorised through the mutual recognition and decentralised procedures;
- test biosimilar medicines in parallel;
- randomly test samples of centrally authorised products from the parallel distribution chain to verify their authenticity;
- carry out ad-hoc testing programmes for active pharmaceutical ingredients (API) sampled during good manufacturing practice (GMP) inspections.
For more information on how EMA will extend the programme in the coming years, and its main results over the last 20 years, under Reports on outcomes.
The number of centrally authorised products tested annually has steadily increased from nine in the 1997-1998 pilot project to 58 in 2017, totalling over 700 products over these 20 years and representing a significant percentage of the total number of centrally authorised products on the market.
EMA's sampling and testing programme is in accordance with Article 57 of Council Regulation 726/2004, which gives EMA the responsibility to coordinate the supervision, under practical conditions of use, of medicines authorised in the European Union.
For more information, see also Sampling and testing: questions and answers.
In this section
How EMA selects products for testing
EMA typically tests 50-60 products a year.
The selection of products follows a risk-based approach.
EMA's Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) approve the selection.
The programme does not cover human vaccines and plasma-derived medicinal products, and immunological medicines for veterinary use, as these are independently tested by an official medicines control laboratory (OMCL) before they appear on the market.
For more information, see:
Programme partners
The sampling and testing programme involves close collaboration between several EU bodies, including:
- EMA, the sponsor with overall responsibility for the programme;
- the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe which coordinates sampling and testing operations, including reporting the results and proposing follow-up actions;
- national inspection services, which take samples;
- members of the network of European Union (EU) and European Economic Area (EEA) official medicines control laboratories (OMCL), which test the samples.
This facilitates sharing of surveillance workload and has successfully reduced duplication of efforts by replacing individual national testing systems for centrally authorised products with one harmonised surveillance procedure applicable to all EU/EEA Member States. The pooling of expertise gives access to novel technology and analytical methods and ensures best use of laboratory resources in the EU/EEA.
It complements national surveillance programmes which focus on nationally authorised products or medicines authorised through the mutual recognition and decentralised procedures. Testing of centrally authorised products can also be carried out by national authorities as part of the national supervision of the product concerned.
The table below includes more details on the responsibilities of EU bodies involved in the sampling and testing programme.
| Programme partner | Responsibilities |
|---|---|
| Rapporteurs and co-rapporteurs at EMA's relevant scientific committee | The rapporteur or co-rapporteur, who led the evaluation of a medicine before it received marketing authorisation, provides recommendations on the tests to be carried that can act as indicator of the quality of the product. They also advise EMA on any follow-up actions necessary after they receive the outcome report. |
| EDQM | EDQM ooordinates the work of the national competent authorities and of the OMCLs for the sampling and testing of the products. It prepares the sampling and testing plan, based on information on the products to be tested, marketing status, tests recommended by the rapporteurs and co-rapporteurs, products specifications and test procedures provided by the marketing authorisation holders. EDQM coordinates the sampling of medicines from the markets (carried out by the national authorities' inspection services) and their testing (carried out by the laboratories of the OMCLs network). EDQM prepares and provides EMA the final outcome reports for each product. |
| OMCLs | The OMCLs test the samples to check if they comply with their authorised specifications. They report to EDQM about the outcomes, including any problems and any 'out of specification' results. |
| National competent authorities | The national competent authorities sample the products to be tested from the national markets and participate in the testing with their OMCL capacities. |
| Marketing authorisation holders | Marketing authorisation holders provide information on test methods, product specifications, reference materials and reagents and the marketing status of their product. They also provide samples of the product from a single batch, to be used as the 'common test sample' by laboratories. They receive a copy of the testing results of their product. |
Reports on outcomes
EMA publishes reports on the outcome of its sampling and testing programme.