EMA is starting a review concerning studies at Alkem, India

Recommendation

27-29 February 2024

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Management, Supply and Quality Assurance of Clinical Trials

The European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted at the Alkem Laboratories Ltd site in Taloja, India. This follows a good clinical practice (GCP) inspection of this site which raised concerns regarding study data used to support the marketing authorisation applications of some medicines in the EU. The inspection was carried out jointly by the German and Dutch authorities in March 2015 in the context of a routine evaluation of applications for nationally authorised medicines.

Having considered the inspection findings, the German medicines agency (BfArM) has requested EMA to assess the impact that these findings may have on the benefit-risk of medicines authorised in the EU on the basis of studies performed at this site. It also has requested EMA to look at the impact on medicines which are currently being evaluated for authorisation purposes and which use study data from the site.

The Agency will now determine which medicines are concerned and will review the available data to determine whether any action is necessary to protect public health.

The press release is available on the EMA website (Referrals).