The European Medicines Agency (EMA) has stressed the essential role of GCP in a new position paper. It has made it clear that companies cannot replace “pivotal trials” that don’t comply with GCP standards during the assessment of marketing authorization applications.
If an application relies on a single trial (pivotal trial) found to be non-compliant, the only option is to re-apply with a new, compliant study.
If a non-pivotal study is found to be GCP non-compliant during an inspection, the applicant/marketing authorization holder (MAH) has several courses of action – such as excluding the affected data or providing a justification as to why the data should still be included.
The timing of the position paper is interesting as it comes whilst the Indian company GVK Biosciences is arguing against a ban on some of its drugs due to manipulation of trial data. Both the company and the Indian government argue that this is disproportionate since the drugs have been used effectively for years without reported problems.
But maybe that isn’t the point.
Just because a drug is tried and tested - if it requires trial data, surely that data should be obtained following the rules of good clinical practice.
The EMA does offer some ground – stating that things like patient’s interest should be considered and part of the risk/benefit equation when deciding on whether to retrospectively ban sales of a drug due to non-compliance of trial data.
After all, the main principle of GCP is protection of the patient…
Fortunately, Whitehall Training offers the widest range of country-specific and international GCP courses on the internet – giving everyone access to effective good clinical practice learning, wherever they are.
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