New EMA Report on the 2008 Sampling and Test Programme

On 19 February 2010, the EMA (European Medicines Agency) published the report "Results of the Sampling and Testing Programme for the year 2008". This report contains information and results regarding the use of medicinal products, and also the results of a programme dedicated to sampling and checking medicinal products in 2008. This type of programme is co-ordinated by the EMA every year, and the 2008 programme was the 9th of its type.

The principal purpose of this programme was to check whether the medicinal products were permitted centrally and are being traded, and whether they conform to the required quality specifications. Furthermore, this supervision activity permits examination of the analytical methods which are used to monitor and control products submitted by the pharmaceutical industry.

Altogether, 42 preparations were tested. Of these, 36 products were designed to be used on humans, plus 6 veterinary products. The samples were drawn directly from trade chemists, hospitals and wholesalers. The corresponding license owners were informed about the fact that their preparations were being analysed in the test programme and they were asked to provide the necessary documentation pertaining to the samples.

As a summary, the test provided the following findings:

1. 17 medicinal products were completely unproblematic.
2. 24 of the products did however contain problematic issues ("issues identified").
3. One product had divergent analysis results, meaning that the product did not correspond to the permitted specifications.

With regard to these problems ("issues"), it was found that this particular product did not conform with either scientific, regulatory, technical or editorial points. Most of the issues which appeared during testing concerned product analysis or licensing issues. As a result, some license owners were required to issue notifications of change.

However, the examination brought to light nothing that could cause immediate danger to the health of patients, which is exactly the same conclusion which the study came to in the previous year's studies.

In view of the results of the "2008 Sampling and Programme Testing", it is to be summarised that such testing procedures are an important instrument of the EMA in supervising the trade in medicinal products.

All other details concerning this report can be viewed here.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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