Non-clinical pharmacological/toxicological testing of medicinal products
Before a medicinal product is placed on the market, it must be analysed, non-clinically pharmacologically and toxicologically and clinically tested in order to assess its quality, safety and effectiveness. A medicinal product is also tested analytically, non-clinically pharmacologically and toxicologically and clinically when it has already obtained a permit for placement on the market or when it is already placed on the market if the test is in order to acquire additional data about the product or because of quality control of the product.
Non-clinical pharmacological and toxicological testing of a medicinal product is a procedure that establishes the safety of the product in accordance with the principles and guidelines of good laboratory practice.
Non-clinical pharmacological and toxicological testing determines the pharmacodynamic, pharmacokinetic and toxicological features of a medicinal product which were established on laboratory animals, isolated organs and tissues and other pharmacological models, and projects the possible effects on humans or targeted animal species.
For products used in veterinary medicine, non-clinical pharmacological and toxicological testing provides, in addition to the data referred to in the previous paragraph, data on pharmacokinetics, especially metabolism and the excretion of residues of medicinal products and data on the routine analytical method which can be used to determine residues of medicinal products.
Non-clinical pharmacological and toxicological testing of a medicinal product is performed by business entities which meet the conditions regarding staff, premises, equipment and the keeping of documentation in accordance with the principles good laboratory practice.
The manner and procedure of analytical and pharmacological and toxicological testing of medicinal products for human use and the content of documentation on the quality, safety and effectiveness of a medicinal product are determined in the Annex to Commission Directive 2003/63/EC of 25 June 2003 amending directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (L No 159 of 27 June 2003, page 46) and in the Annex to Directive 2009/120/EC.
Detailed guidelines and the content of the documentation referred to in the previous paragraph are published in the guidelines adopted by the European Commission: The Rules Governing Medicinal Products in the European Union, Volume 3 – Medicinal Products for Human Use: Guidelines.
Conditions and evidence
- Medicinal Products Act
- Rules on analytical, pharmacological- toxicological and clinical testing of medicinal products for human use
- Rules on method and procedure of the analytical, pharmacotoxicological and clinical testing of veterinary medicinal products
- Rules on conditions for completing activities of making medicinals and determining of conditions and procedure of publishing or revocation of execution good production practices
- RECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- COMMISSION DIRECTIVE 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products