Biotherapy

, Volume 1, Issue 1–2, pp 59–69 | Cite as

Regulatory affairs and biotechnology in Europe

I. Introduction into good regulatory practice
  • Ben Tryzelaar
Article

Abstract

The high cost and risks associated with the research and development of new drugs demand an alert as well as realistic legislative policy at both national and international levels. Registration of a new drug required before a marketing licence is granted, is important for all branches of the pharmaceutical industry but is crucial for success in the innovative biotechnological sector.

Innovation as such is no guarantee to be profitable. Increasing government demands have introduced uncertainty on whether new products will secure registration and have led to a disproportionate increase in the economical risks for innovative industry. Preparation and submission of an application for registration should be undertaken seriously and professionally since it has significantly more consequences than simply obtaining a marketing licence. It will influence marketing strategies and results. It is proposed — since dealing with regulatory affairs can be considered as an essential specialism — to apply a Quality Assurance approach. Activities in this context should comply with the same performance standards as developed for GMP, GLP and GCP leading to Good Regulatory Practice (GRP).

By acknowledging regulatory affairs as a quality assurance means one can define a set of standard procedures within an organization to ensure that decisions are made on current and future regulations. In such a setup regulatory affairs becomes a marketing tool.

This paper illustrates the complex problems found in registration activities. It underlines the necessity of introducing a GRP-approach of performance resulting in substantive evidence of regulatory efficacy.

Keywords

Quality Assurance Performance Standard International Level Substantive Evidence Marketing Strategy 

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References and notes

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    Draft guidelines/notes to applicants (to be finalized during 1988 or later: not all ref. numbers were known at date of publication):- general rules and scientific principles for the conduct of clinical trials;- trials in children;- trials in the elderly;- anti-arrhytmic drugs;- stability tests on active substances and finished products (III/66/87);- anticancer drugs;- antidepressant drugs;- drugs for cardiac insufficiency;- data required before clinical trials;- toxicity testing of products derived from biotechnology (III/407/87);- local toxicity;- chemistry of the active ingredients (111/478/87);- development pharmaceuticals and process validation (III/847/87);- analytical validation.Google Scholar
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Copyright information

© Kluwer Academic Publishers 1988

Authors and Affiliations

  • Ben Tryzelaar
    • 1
  1. 1.Strategic Biotech InternationalZeistthe Netherlands

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