Testing Requirements Print

The role of the European pharmaceuticals legislation is to ensure the best safety, quality and efficacy of medicines.

Directive 2004/27 sets rules for the authorisation, manufacture and distribution of medicinal products for human or veterinary use, and seeks to safeguard public health.

According to the legislation in force medicinal products to be placed on the market require a marketing authorisation, which demonstrates that medicines demonstrate the necessary quality, safety and efficacy.

Quality includes issues relating to chemical and pharmaceutical quality assurance. Safety includes issues relating to in vitro and in vivo non-clinical safety studies. Efficacy includes matters relating to clinical studies in humans.

The development of a medicinal product is a stepwise process involving the evaluation of quality, pre-clinical and clinical data, which includes information generated during animal and human studies.

The place of animal studies in the legislation

The legislation requires a certain number of studies on animals to secure maximum safety of the molecules before they can be administered to patients.

Specific guidance as to the type of tests is set by:

  • OECD (guidelines and monographs)
  • Committee for Human Medicinal Products at EMEA, notice to applicants, so called “guidelines"
  • European Pharmacopoeia (monographs)
  • ICH (guidelines) – harmonisation of requirements between the EU, US and Japan

The questions that animal studies address are complex and include amongst others:

  • Have potential human adverse effects at particular exposure been identified?
  • What is a safe first dose in humans?
  • How much toxicity is reasonable for humans at the particular stage of drug development?
  • Is an identified adverse effect reversible?
  • How high is a reasonable to dose for humans?
  • What should be monitored in humans and how frequently?
  • Is the drug reasonably safe for a person who wants to get pregnant or is pregnant?
  • What are the long-term effects of taking the drug?