This paper discusses a representative sample of the main deficiencies identified by European agencies in the “Chemical, Pharmaceutical and Biological documentation” of Marketing Authorization Applications for chemical active substances. The plan followed in the paper is that of the European Part II file. Each deficiency is illustrated by examples. Specific European references are listed, as well as new texts. The paper also comments on the presentation of the pharmaceutical dossier and expert report.
Committee for Proprietary Medicinal Products.Note for Guidance on development pharmaceutics. London, UK: CPMP/QWP/155/96; January 1998.
2.
Committee for Proprietary Medicinal Products.Note for Guidance on process validation. London, UK: CPMP/QWP/848/96; September 1999.
3.
Pharmeuropa. Volume 11.3, 533/535. Strasbourg, France: Council of Europe; September 1999.
4.
European Commission.A second draft of the “Note for Guidance on specification limits for residues of heavy metal catalysts in Medicinal Products” is in preparation (The first draft was discussed by SWP in January 2000). Brussels, Belgium: European Commission, Directorate General III.
5.
European Union. Commission Directives 1999/82/EC and 1999/83/EC (September 1999) amending the Annex to the Commission Directive 75/318/EEC. Deadlines: July 1, 2000 for new applications and March 1, 2001 for already authorized products. Note for Guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via medicinal products (CPMP/BWP/1230/98, April 1999). Resolutions AP-CSP (99) December 4, 5, 1999.
6.
European Union. Council Directive 90/220/EEC. Council Regulation (EEC) n° 2309/93. Brussels, Belgium: European Union; 1993.
