Environmentally friendly drugs

The question of pharmaceuticals in the environment has been of interest in many fora for many years. For some time now there has been a requirement for Environmental Risk Assessment for new medicinal products but industry has suffered from a lack of guidance from the regulatory authorities as to what this assessment should include. Two sets of proposals have been issued, in 1995 and 2001 respectively, but as yet the definitive guidance has not emerged.

The whole question of pharmaceuticals in the environment was the subject of a recent conference in Lyon, France, at which the whole field, including the impact of veterinary medicinal products was discussed. While there is a welter of reports giving details of the presence of pharmaceuticals in the environment, the analysis of the practical significance of these findings is still open to debate.

It is anticipated that a draft CPMP Note for Guidance on this subject will be issued in the summer of this year and could be implemented sometime next year.

This is to be welcomed, as the uncertainty around the requirements for medicinal products is causing concern to applicants as to what data they need to provide. The lack of definitive guidance in the pharmaceutical legislation also undermines any claims in discussing general environmental legislation that environmental fate is adequately covered in medicines legislation.

The pharmaceutical industry looks forward to receiving the CPMP proposals on this Note for Guidance and will seek to ensure an outcome acceptable to all parties.