EU pharma companies offered guidance on how to manage mutagenic impurities

Published: 20-Oct-2014
Regulatory

Advises on clinical development and marketing authorisation procedures for new and previously approved medicines


Guidance has been released to European Union (EU) pharma companies to help them assess and control the emergence of mutagenic impurities in medicines that could help cause cancer.

The advice was originally developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which also advises regulators in Japan and the US, and has been assessed and released in the EU by the European Medicines Agency (EMA). It advises on clinical development and marketing authorisation procedures for new and previously approved medicines where:

  • Changes to drug synthesis create new or increased existing impurities;
  • Changes in the formulation, composition or manufacturing process generate new or more existing waste elements; or
  • Changes in indications or dosing rules are made that significantly affect cancer risk levels.

The ICH explained that the guideline advises on analysing structural relationships regarding genotoxicity. It also helps resolve questions such as whether impurities with similar effects should be combined in calculating thresholds of toxicological concern (TTC) and whether these should vary depending on how long a medicine is taken.

The guidance is not applicable for advanced cancer drugs, biological/biotechnological, peptide, oligonucleotide, radiopharmaceutical, fermentation and herbal medicines, crude products of animal or plant origin, and drugs supposed to be genotoxic, and others.

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