From Mr A. McMath and Mr C. Pouget
SIR,—We write with regard to the article on quality issues in drug development (PJ, September 11, p394) and in particular "requirements in relation to active substances".
We would like to add that for certain pharmacopoeial substances listed in the European Pharmacopoeia conformity to the necessary monographs can be shown by obtention of a certificate of suitability from the certification secretariat of the European Department for the Quality of Medicines of the European Pharmacopoeia (EDQM).
This is recognised in the EC note for guidance on "requirements in relation to active substances" III/8315/89 in force since January, 1992, and also the recent note for guidance on "summary of requirements for active substances in Part II of the dossier", in force since July, 1998.
A. McMath
Scientific Officer, European Department for the Quality of Medicines
C. Pouget
Head of Certification Unit, European Pharmacopoeia, Strasbourg, France