EMEA pushes ahead with pharmaceutical harmonisation

The European Medicines Agency (EMEA) is to push for global approximation of pharmaceutical industry regulation for some key topics.

EMEA is a key member of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) project. It unites regulators for Europe, Japan and the US and pharmaceutical industry experts to discuss scientific and technical aspects of product registration.

The agency has drafted guidelines for other ICH regulators on some key topics where global regulatory harmonisation is sought. These include guidance on non-clinical safety studies within human clinical trials; genomic biomarkers related to drug response; disintegration tests; sterility tests; tablet friability; and polyacrylamide gel electrophoresis.

As regards the non-clinical safety studies, EMEA said: "It is recognised that significant advances in harmonisation of the timing of [these assessments] have already been achieved. However, differences remain in a few areas."

These differences include combination drug toxicity testing, paediatric studies, repeated dose toxicity studies, and others.

According to the ICH, the aim of these studies is "to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.. to reduce or obviate the need to duplicate the testing carried out.."

EMEA has also released answers to debates on important regulatory harmonisation questions, such as common technical documents for the registration of pharmaceuticals for human use.