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The GMP requirements for biotechnological medicinal products are more complex and scientifically demanding than those for chemically synthesised products. They are based on a dense network of European and international regulations. But what are the regulatory principles and what are the specific features that distinguish them from "traditional" products?

ATMPs promise medical breakthroughs in diseases that have been difficult to treat until now. However, with the individualisation of these therapies, pharmaceutical quality and regulatory concepts are increasingly reaching their limits. In particular, the question of how to define suitable product specifications for patient-specific therapies is becoming one of the key challenges. The new position paper from the ECA ATMP Group highlights this issue and discusses why a more patient-centred approach to setting quality requirements may be necessary.

Due to high demand, the ECA has extended its special offer of sending two additional participants free of charge for each registered participant and a two-year membership for all congress participants and PharmaTechnica visitors until 31 January. After that, the 2-for-1 offer will apply until the congress.

The British National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), with the support of other European authorities, the FDA and industry representatives, has published a survey on MAT in pyrogen testing and is calling for participation.