Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

Regulatory NewsRegulatory News | 28 March 2019 |  By 

The European Medicines Agency (EMA) and European Directorate for the Quality of Medicines and Healthcare (EDQM) on Thursday released a report detailing findings from EMA’s drug sampling and testing program over the last 20 years.
EMA says it plans to extend the program to include biosimilars and that it will expand the generic sampling and testing program first launched in 2011 to include products authorized via the mutual recognition and decentralized procedures.
Additionally, EMA says it will begin checking products in parallel distribution for authenticity under the program and says it will begin a new ad hoc program for testing active pharmaceutical ingredients (API) of centrally authorized products during good manufacturing practice inspections.
In 1997, EMA launched a pilot project to sample and test centrally authorized medicines to survey the quality of medicines on the European market.
Specifically, the program is intended to monitor the quality of finished drug products to ensure that drugmakers have adequate manufacturing controls in place by assessing products according to five parameters.
Following the pilot phase, the program became part of EMA’s routine testing efforts and by 2017 had tested more than 700 products. As of 2004, the program also includes the retesting of products.
For each product tested under the program, EDQM creates a centrally authorized product testing report (CTR) that is sent to EMA and the official medicines control laboratories (OMCLs) across the EU that participate in the program. The report can have one of three final outcomes:
  1. All results comply – no problems identified
  2. Issues identified to be taken up with experts/rapporteur/co-rapporteur
  3. Out of specification results
According to EMA, most of the issues identified during testing are addressed by requiring manufacturers to amend their production controls. However, “in a small number of cases, the tested samples were not compliant with the authorized quality specifications for the medicine and required other regulatory actions such as re-testing, inspections, recalls or suspension of supply,” EMA writes.
In total, EMA says that four batch recall procedures have been initiated as a result of issues identified through the program.
Overall, the report found that 9% of the parameters tested for human and veterinary pharmaceuticals raised some technical, scientific or regulatory issues, whereas 18% of parameters tested for human biological products and 25% of veterinary immunological products raised issues.
“For human biological products, the higher level of major technical/scientific or regulatory issues might be linked to the fact that the products are more complex and as a consequence the test methods involved are usually more sophisticated and sensitive,” EMA writes.
Based on feedback from the OMCLs that conducted testing for veterinary immunological products, EMA says the higher percentage of issues may be the result of “less detailed” standard operating procedures in the veterinary field.
EMA, Report


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