This activity involves the General European OMCL Network only.

Background

Market Surveillance Studies (MSS) are carried out on commercialised medicines, particularly on those having a national marketing authorisation.

Products are tested according to a common protocol and on the basis of national sampling procedures.

To ensure that the same types of medicines are of comparable quality in the different member states, these studies are multilateral. Several are organised yearly. They look at different types of finished products for a given active substance and at herbal drugs.

Where a need is identified, the results of these studies could support revision of the relevant European Pharmacopoeia monographs and/or general chapters and methods.

Since 1999, more than 60 MSSs have been organised within the Network and more than 4470 finished medicinal product samples have been tested in order to control the quality of medicines available on the European market. This position paper adopted in May 2023, highlights the benefits of MSS. 

Achievements in 2024

Pregabalin hard capsules (MSS062)

A market surveillance study on Pregabalin hard capsules (MSS062) was launched in 2024. Thirteen Official Medicines Control Laboratories (OMCLs) from twelve European countries enrolled in the study, which focused on the analysis of key parameters of generic pregabalin capsules (identity, assay, related substances and content uniformity), to assess their compliance with authorised specifications.

Rosuvastatin APIs and tablets (MSS063)

Fifteen OMCLs representing fifteen European countries participated in the market surveillance study on Rosuvastatin API and tablets (MSS063) launched at the end of 2023. The testing phase was conducted throughout 2024, and the results will be published in 2025.

Medical face masks (MSS064)

Four laboratories from four European countries participated in a market surveillance study on masks for medical use as defined by EN 14683 and falling within the scope of the EU legal framework on medical devices – Regulation (EU) 2017/745 (MDR).

This study, launched in 2024, was both a retrospective and a prospective exercise, covering the analysis of masks conducted between March 2020 and June 2024. A total of 344 samples/batches, representing over 10,700 individual mask units from 113 different manufacturers were analysed for bacterial filtration efficacy, microbial cleanliness, breathability and splash resistance.

The findings revealed that 47% of the analysed samples did not comply with specifications for at least one of the four tested parameters, with 10% showing non-compliance with two or more parameters.