When there is no indication that an active substance’s stability is compromised data from formal stability studies should not be needed, it says
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Medicines Agency (EMA) have clashed in a consultation over a planned EMA guideline on stability testing for applications to vary marketing authorisations.
The EFPIA said the guidance 'appears to recommend formal stability studies on the active substance or drug product for certain variations even when the active substance is known to be stable'. It argued that in such an instance, when there is no indication that an active substance’s stability is compromised 'data from formal stability studies should not be needed for either the active substance or the resulting drug product'. Instead, the EFPIA wanted the guidance to make clear that should existing long-term or new data back a new application as being safe, no additional further stability data should be demanded by regulators. EMA replied that this argument was 'not accepted'.
Another dispute emerged over EFPIA comments that assessments over whether formulation changes will have an impact on stability should not always rely on formal studies. 'If a science/risk-based approach is taken and enhanced product knowledge and process understanding is demonstrated existing information could be used', said the EFPIA. Here again, EMA refused to take EFPIA’s advice, saying that there was 'no need to add such a statement'.
Another criticism from the EFPIA was that overall the proposed guidance does not differentiate sufficiently between stable and unstable products or conventional and critical dosage forms when defining specific stability requirements.
'We would expect that a justification of reduced stability requirements could be made based on the inherent stability of the active substance or drug product,' said the EFPIA.
It also requested that an effort should be made to standardise terminology within the guidance, which it said uses contrasting advice for similar actions – saying they 'may be considered as acceptable' or in other cases, 'are recommended'.