A Review of the European Community Regulatory Requirements for Expedited and Periodic ADR Reporting
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
Rinted in the USA. All rights reserved.
A REVIEW OF THE EUROPEAN COMMUNITY REGULATORY REQUIREMENTS FOR EXPEDITED AND PERIODIC ADR REPORTING BARRYD. C. ARNOLD,MB, BCH, FRCA, MFPM Manager, Product Safety Group, Zeneca Pharmaceuticals, Macclesfield, United Kingdom
The European Community’s (EC) current legislative requirements (Council Regulation 2309/93 and Council Directive 93/39/EEC) f o r expedited and periodic adverse drug reaction (ADR) reporting for medicinal products marketed within the EC have been effectivesince January I, 1995. They have been known as the “Future System” and have been supported by guidance provided within the draji Notice to Applicants (December 1994). Thus far, the Future System has not been effective in achieving harmonization of pharmacovigilance within Europe. Full implementation has yet to occur in many EC countries and, where it has occurred, variations in national interpretation of the legislation have occurred. Furthermore, inconsistencies exist between the regulation and the directive, between them and the Notice to Applicants, and also with respect to recommendations from the lntemational Conference on Harmonization. Key Words: Adverse drug reactions; European Community; Regulatory requirements
INTRODUCTION PHARMACEUTICAL manufacturers, as well as regulatory authorities, have the responsibility of making the use of medicines as effective and as safe as possible. It is essential that pharmacovigilance is conducted throughout the life cycle of each drug product and that this should include the collection and evaluation of safety data from all available sources on an international basis, with appropriate evaluation and reporting mechanisms.
Presented at the DIA 32nd Annual Meeting “The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June 9-13, 1996, San Diego, California. Reprint address: Dr. Barry D. C. Arnold, MB, BCh, FRCA, MFPM, Manager, Product Safety Group, Zeneca Pharmaceuticals, Alderley Park. Macclesfield. Cheshire, United Kingdom SKI0 4TG.
Achieving this can be a considerable burden, and one that is not made any easier by constantly changing regulatory requirements that are diverse and often vague. To this day, the situation remains that different authorities request that information from the same source be presented according to different inclusion criteria, formats, and time intervals. It continues to beg for the introduction of a single harmonized system for the worldwide communication of safety information. When it was first announced, it was anticipated that the Future System legislation would create a coherent international system for pharmacovigilance within the European Community, with a single set of requirements which could be translated into unambiguous and practical working procedures, thus ensuring an efficient exchange of information in the interests of patient safety.
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