Clinical 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.
Clinical testing of a medicinal product for human use is research on healthy individuals and patients for the purpose of discovering or confirming the clinical and pharmacological effects of the tested medicinal product, discover undesired effects of the product or examine the absorption, distribution, metabolism and excretion of the product in order to prove its safety or effectiveness in human use.
Clinical testing of medicinal products for the use in veterinary medicine is an organised examination of the effects of medicinal products on the animal organism for the purpose of discovering or confirming the clinical and pharmacological effects of the product for the use in veterinary medicine, to discover the undesired effects of the product or examine the absorption, distribution, metabolism and excretion of the tested product and its residues in order to prove its safety or effectiveness in targeted animal species.
A non-routinely prepared medicinal product for advanced therapy must not be clinically tested.
Clinical testing of medicinal products is carried out by the health-care service or veterinary service providers which dispose of staff authorised to prescribe medicinal products in accordance with the regulations and principles of good clinical practice.
The manner and procedure of analytical and pharmacological and toxicological testing of medicinal products for human use and the content of documentation on their quality, safety and effectiveness are determine 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
- Status and registration Principles of clinical trials of medicinal products Liability insurance for damages caused to trial subjects Examiner’s consent to the appointment of researchers and the use of premises, staff and equipment Provision of conditions for the principal researcher to implement a clinical trial Enabling the undisturbed work of an assessor, monitor, pharmaceutical supervisor Appropriate staff Lead investigator in the clinical trials of medicinal products Researcher in the clinical trials of medicinal products Protection of rights of trial subjects Approval for clinical trials on medicinal products Notification of clinical trials on medicinal products Notification of changes of clinical trials on medicinal products Notification on the completion of a clinical trial Report on a clinical trial of a medicinal product Informing and reporting on serious adverse reactions to medicinal products being tested Appropriate labelling of medicinal products being tested Storage of data on clinical trials
- 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 clinical testing of medicinal products
- 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