Drug proving

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Under drug testing refers to the testing of drugs on their quality , efficacy and safety, the non-clinical form and clinical trials as part of the Food and Drug is performed or drug registration. There are a number of test regulations or test guidelines for drug testing that the pharmaceutical company must apply.

  • At the European level, the responsible working groups at the European Medicines Agency develop scientific guidelines that define the requirements for appropriate drug testing. These guidelines serve a uniform, harmonized interpretation and implementation of the requirements for the proof of quality, safety and effectiveness of drugs in the legal framework of the European Community.
  • At the national level, there are drug testing guidelines in Germany in accordance with Section 26 of the Drugs Act (AMG). They were first issued in 1989 with the general administrative regulation for the application of the drug testing guidelines of the then Federal Ministry for Youth, Family, Women and Health (BMJFFG) and were revised in 1995. For drug testing, not only the procedures explicitly listed in the annex to the administrative regulation for proof of quality, efficacy and safety had to be taken into account, but generally all recognized - essentially the relevant European - guidelines to which no express reference is made. With the Drug Testing Guidelines Ordinance (AMPV) of January 2016, the application of the drug testing guidelines , the content of which corresponds to Annex I of Directive 2001/83 / EC (Community Code for Human Medicinal Products) , was also made legally binding.

The homeopathic drug proving , which serves to describe the drug picture of a homeopathic drug , must be distinguished from the drug test in the sense described . The homeopathic remedy picture is an essential criterion for the creation of a homeopathic therapy scheme.

Individual evidence

  1. ↑ Scientific guidelines for medicinal products for human use (English) of the working groups of the Committee for Medicinal Products for Human Use of the European Medicines Agency.
  2. ↑ Scientific guidelines for veterinary medicinal products (English) of the working groups of the Committee for Veterinary Medicinal Products of the European Medicines Agency.
  3. ↑ Announcement on the approval of medicinal products , BfArM, November 27, 2000.
  4. ↑ Ordinance on the application of the drug testing guidelines (Medicinal Testing Guidelines Ordinance - AMPV)