EU guidance developments

For some time there has been confusion over the process by which the various classes of guideline used by the European pharmaceutical regulatory authorities have been derived and also their regulatory status.

In an effort to make the process more transparent, the European Medicines Agency (EMEA) recently issued a consultation paper to seek to clarify the questions that have been posed and to set out a more 'transparent' process for developing guidance.

In its consultation document, the Agency sets out proposals for a ten step process for drafting a guideline and identifies consultees at each stage. It also seeks to identify the status of the various types of guidance that are issued.

The publication of this document highlights the number and variety of guidelines that face manufacturers in the pharmaceutical arena, and the concept of rationalising and harmonising the EU process is to be welcomed.

The document also acknowledges that many of the guidelines are a result of co-operation through the International Conferences on Harmonisation (ICH/UCH), which co-ordinate activities between the EU, Japan and the US, and therefore scope for interpretation is limited.

The consultation period for the proposals lasts until December of this year, and the ABPI and fellow trade associations will be considering the proposals carefully.

This column will no doubt return to the outcome of the consultation.