Following the completion of a clinical trial, it is necessary to dispose of the biomaterials used during the study. This is a complex process involving a number of steps which must be carefully followed to ensure safe disposal. Russian law does not provide specific regulations to the disposal process, although there are articles related to some steps in it.
What needs to be disposed of after a trial?
Firstly, we need to understand what we have to dispose of after a clinical trial. Materials for disposal include:
Drugs that fit the pharmaceutical standard, but were not used during a clinical trial;
Drugs that were going to be used in a clinical trial, but their expiration date passed;
Drugs that are returned by clinical trial participants, even if the container was not opened;
Containers used during a clinical trial;
Drugs with a container seal broken or damaged;
Drugs with unknown storing conditions returned by clinical trial participants.
But when does the time to dispose of these things come? Usually, the disposal needs to be conducted after the finish of a clinical trial (or a stage of a trial during which the drug was used) or in the case of the trial’s cancellation.
The disposal process
Upon completion of a trial or in the case when a trial is cancelled there are specific measures which need to be taken to dispose of research materials. During the disposal process, researchers have to follow the laws of their individual countries. In Russia, rules include:
Mix it with a substance that will definitely not attract anyone’s attention;
Drugs must be placed in a sealed container;
All identifying marks or labels must be removed or erased.
Written approval from the clinical trials’ sponsor must be obtained before disposal
And the paperwork must be maintained to prove the fact of the complete disposal of the drug after a clinical trial.
The medications used during the trial also need to be stored separately from any other biomaterials.
Disposal must be carried out by a licensed service provider
COREX Logistics is a licensed provider of disposal services for clinical trials and has an excellent track record in providing these services in a safe and efficient manner.
The pharmaceutical industry has faced numerous challenges since the beginning of 2021 including the rush to supply COVID-19 vaccines. The start of the year also saw the departure of the UK from the EU and theEuropean Medicines Agency (EMA). The Medicines and Healthcare Products Regulatory Agency (MHRA) is now fully in charge of all regulatory matters, oversight of clinical research and approval of medicines.
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