Comments on a draft European Medicines Agency (EMA) guideline on setting health-based exposure limits for assessing the risk of manufacturing different medicinal products in shared facilities
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has stressed that dedicated facilities for manufacturing specific medicines are not needed, as long as clear health-based limits on cross-contamination of ingredients from other products can be maintained.
The EFPIA was commenting on a draft European Medicines Agency (EMA) guideline on setting health-based exposure limits for assessing the risk of manufacturing different medicinal products in shared facilities. And while generally welcoming the new advice, the Federation called for more flexibility so that some existing arrangements by manufacturers making different medicines in the same plants could be maintained.
The EFPIA said: 'Using the new methodology for the entire library of existing products would be unmanageable and of no benefit to patients.'
The Federation also argued that the proposed use of new toxicology guidance to all medicines was 'excessively broad' and called for EMA to apply it to new medicines only – a call rejected by the EU agency.
The EFPIA added that EMA should stage a workshop to explain its final guidance to companies.
EMA’s proposals have been welcomed by GlaxoSmithKline, which commented: 'We appreciate the complexity to assure assessments are performed by a standard and consistent approach…'.
However, the pharmaceutical manufacturer called for clarified advice regarding residues from medicines with multiple active pharmaceutical ingredients.