These activities involve the EU/EEA OMCL Network only.

Background

Since 1995, the Commission of the European Union has being granting community marketing authorisations for new medicines for both human and veterinary use. These are known as centrally authorised products (CAP). Such products can be marketed in all EU/EEA member states, so a co-ordinated approach to controlling the quality of these products is necessary. In June 1999, a contract governing an annual CAP Sampling & Testing Programme was signed by the European Medicines Agency (EMA) and the EDQM. The EMA is the sponsor of the programme and has overall responsibility for it, whereas the EDQM co-ordinates the sampling and testing operations. The EDQM’s duties include reporting the results of the testing programme and proposing follow-up actions, if necessary, to the EMA. National inspection services gather sample products from the market and members of the EU/EEA OMCL Network test them.

Since 2009, each annual programme has included products selected using a risk-based approach. Previously, a systematic approach had been used, i.e. each yearly programme included products that had been granted a community market authorisation 3 years previously.

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The Procedure

The list of products to be included in the annual programme is prepared by the EMA Secretariat in collaboration with the EMA Scientific Committees. This is sent to the EDQM, which then co-ordinates the sampling and testing operations on the basis of the information provided by the marketing authorisation holders (MAH) at the request of the EMA. Samples are collected, in principle, from throughout the entire medicines distribution chain (i.e. from wholesalers and community and hospital pharmacies) by nominated national sampling contacts. Samples are collected, on average, from three different countries. These are sent to the EDQM, which allocates them to national control laboratories for testing in accordance with well-established protocols derived from marketing authorisation (MA) dossiers. The EDQM collects the analyses and results and produces a report, which includes the quality control results and proposals for follow-up action, if necessary. This report is sent to the EMA.

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Benefits of the CAP Sampling & Testing Programme

A position paper: The advantages and benefits of the CAP Surveillance Project, was released in November 2013. This document underlines the value of this multi-disciplinary activity and also includes a statistical evaluation of the programme as well as a chapter discussing future considerations.

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Achievements in 2021

The concerted sampling and testing activities of Centrally Authorised Products (CAP) has entered its 23rd consecutive year. Since its initiation, the programme has been continuously improved thanks to the close collaboration between its partners.

For the Regular programme, a list of products to be included in the annual programme is prepared by the EMA Secretariat together with the EMA Scientific Committees and with input from the OMCL Network and the EDQM applying a risk-based approach. Regarding the CAP Generics test programme, three generics testing campaigns are conducted every year. As of 2019, three new programmes have been added to these well-established programmes.

The 2021 CAP Regular programme included 33 medicinal products for human use (16 biologicals, including 2 insulin-based products, and 17 chemical products) and 6 medicinal products for veterinary use (3 immunobiological products and 3 chemical products). In addition to the finished dosage form, testing of the active pharmaceutical ingredient (API) was performed for 1 product. Finally, for some selected products testing for N-Nitrosamines has been added to the programme.

In the frame of the 2021 CAP Generics surveillance programme, products containing Aripiprazol, Olanzapine and Rivastigmine were tested.

Due to the increasing number of biosimilars, a Biosimilar programme with 3 projects is conducted over a period of five years (2019-2023), on CAP products including Filgrastim, Etanercept and Rituximab.

A dedicated programme for the testing of Parallel distributed products aims at checking the authenticity of the products. Five products had been tested under this programme in 2021.

Since a high percentage of APIs are produced outside of the EU/EEA which are used for the manufacture of medicines for the European market, an ad-hoc CAP API programme is conducted and allows sampling and testing of a maximum of three APIs per year in connection with suspected GMP issues. Due to limited site presence of GMP inspectors caused by the pandemic situation, no ad-hoc CAP API testing was requested in 2021.

The results of the 2021 programmes showed that the vast majority of products tested were of the expected quality and complied with the authorised specifications. By 31 December 2021, for one product out-of-specification results for two testing parameters, and for a few other products regulatory or technical findings had been reported to and followed up by the EMA.

The EDQM’s coordination activities with respect to the CAP Programme are certified by AFNOR Certification and audited on a regular basis.

Status on January 2022

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