In the last 20 years, we have seen a global emphasis on quality as a leading priority in all industrial activities. Cars no longer require checks at short intervals, the goods we purchase in supermarkets clearly indicate their country of origin and expiry date, and so on. The pursuit of quality in Medicines Development is no exception. It is a frequent focus in Academy lectures that professionals in Medicines Development have an ethical obligation to look for top-level quality from laboratory studies (GLP) to clinical studies (GCP) and finally, to the manufacturing of all drugs (GMP). We are often developing drugs to treat patients with severe diseases, and as such, we cannot compromise the quality of our work under any circumstance.

As such, it was with industry-wide frustration that we read the enclosed press release from the EMA:

“EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorizations of several generic medicines tested by Synchron Research Services, a CRO located in Ahmedabad, India. The recommendation comes after irregularities were found in how the CRO carried out bioequivalence studies, which raised serious concerns about the company’s quality management system and the reliability of data from that site. 

EMA and national authorities will continue working closely together to ensure that studies on EU medicines are carried out to the highest standards and that companies comply with all aspects of good clinical practice (GCP). If companies do not meet required standards, authorities will take whatever measures necessary to ensure the integrity of data used to approve EU medicines.”1

In light of this announcement from the EMA, we would like to take the opportunity to remind professionals in Pharmaceutical Medicines of two key issues when outsourcing studies to CROs:

  1. The selection of a CRO is a difficult and complex task, which should be managed by expert professionals who are able to understand strengths and weaknesses of each proposal. It is also an important reminder that GCP states that, even in outsourcing studies to a CRO, the final study responsibility remains with the Sponsor!
  2. Regulatory Authorities have the duty and the right to impose inspections to clinical trials, visiting not only the clinical site, but also the Trial Master File stored with the CRO and the Sponsor. This is an important guarantee that quality will be verified by competent personnel, for the safety of all patients worldwide.

Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred

References

  • Synchron Research Service: suspension of medicines over flawed studies. (2022, May 20). European Medicines Agency. https://www.ema.europa.eu/en/news/synchron-research-service-suspension-medicines-over-flawed-studies