title: [Overregulation and unnecessary animal testing: requirements for market approval of biopharmaceuticals too rigid].
abstract: The first biopharmaceutical was introduced more than 30 years ago. From the beginning, experts have doubted the scientific basis for preclinical safety testing of these products on animals, including non-human primates. Long clinical experience confirms that this has no scientific basis. The many guidelines introduced over the years, including the recent revision of ICH S6, are still based on the principles of the classical safety evaluation of small molecules. The reasons for this conservatism include the risk-averse attitude of regulators in general and, at the European level, the low influx of new scientific insights due to the way the marketing authorisation is organised. The members of the scientific committees of the EMA are almost exclusively selected from within the regulatory systems and there is no limit in the time they can serve in these committees.
authors.affiliation: Universiteit Utrecht, Utrecht, the Netherlands. h.schellekens@uu.nl
authors.forename: Huub
authors.initials: H
authors.lastname: Schellekens
mesh_terms: D032761:Animal Experimentation / Q000331:legislation & jurisprudence*; D000818:Animals; D001702:Biopharmaceutics / Q000331:legislation & jurisprudence* / Q000639:trends; D004353:Drug Evaluation, Preclinical; D017408:Guidelines as Topic; D006801:Humans; D009426:Netherlands; D060735:Pharmacovigilance