Ukraine. Pre-clinical trials

Pre-clinical study of drugs envisages a complex of chemical, physical, biological, microbiological, toxicological and other science researches of drugs which are carried out before the the beginning of clinical trials.

Procedure for pre-clinical drugs studies, requirements to conditions of single researches as well as procedure for expert examination of materials for pre-clinical trials of medicinal products is determined by the Decree of MHC of Ukraine dd. 14.12.2009 #944 «On approval of procedure for conduction of pre-clinical drug trials and expert examination of pre-clinical drug trial’s materials».

The pre-clinical trial is conducted in following directions: establishment of pharmacological efficacy of medicinal products, study of their pharmacokinetics and toxicological researches.

The pre-clinical trial shall be conducted by research institutions irrespectively their ownership form and departmental subordination which are able to provide respective methodical and scientific level of pre-clinical study of safety and efficacy of drugs as well as duly adherence according to the current legislation to principles of humane treatment of laboratory animals, if any.

Customer of pre-clinical trial is a legal entity irrespectively of its ownership form or an individual which/who initiates conduction of pre-clinical trial, determines its scope, approves and provides financing for pre-clinical drug trial.

There are following types of pre-clinical trials: study of the test-sample’s toxicity, reproductive toxicity, embryo-toxicity and teratogenicity, mutagenicity and cancerogenic potential, pharmacodynamics, pharmacokinetics, and local effect of the test-sample.

Test-sample for pre-clinical trial shall be provided by the ordering customer together with a quality certificate for each series signed by an authorized person of the manufacturer. There are two types of trials: short-term of 2-4 weeks and long-term of 3-6 months.

The actual pre-clinical trial shall be preceded by an evaluation of ethical, moral and legal aspects of the trial as well as by an approval of a written protocol (plan) of the pre-clinical trial. The protocol shall correspond with requirements of GLP and shall be agreed upon with the head of the research institution and the customer. Results of the pre-clinical trial shall be set out in a report signed by the trial director and approved by the head of the research institution and the customer.

In case information in the provided materials revokes any doubts as to its authenticity or if there is no documented evidence regarding adherence to GLP requirements during toxicity and safety studies, an audit of the pre-clinical can be carried out during the expert examination of pre-clinical drug trial’s materials. The results of the audit shall be stated in a respective report.

All materials of a pre-clinical trial, including the report copy, shall be kept in the archives of the research institution for at least 5 years.
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