Regulatory Focus™ > News Articles > EMA Assesses Concerns With Indian Generic Firm’s Clinical Data

EMA Assesses Concerns With Indian Generic Firm’s Clinical Data

Posted 06 April 2016 | By Zachary Brennan 

EMA Assesses Concerns With Indian Generic Firm’s Clinical Data

The European Medicines Agency (EMA) has begun a review of medicines for which studies have been conducted at Alkem Laboratories’s site in Taloja, India due to data integrity concerns.

The review follows a joint good clinical practice (GCP) inspection of this site by German and Dutch regulators in March 2015, which raised issues with study data used to support the marketing authorization applications of some medicines in the EU.

Following consideration of the inspection findings, the German medicines regulator (BfArM) requested that EMA assess the impact of its findings and how they may affect the benefit-risk profiles of medicines based on studies performed at the Alkem site.

BfArM regulators also requested EMA look at the impact on medicines which are currently being evaluated for authorization purposes and which use study data from the site though neither regulator outlined which medicines are involved in the review. EMA says it will now review the available data to determine whether any action is necessary to protect public health.

Most recently, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) inspected the Taloja site, according to Alkem, and though the company says it will respond to the report's deficiencies, it “does not anticipate any impact on its existing registered products in EU market.”

According to Alkem’s latest earnings report from February, year-on-year international growth for the company was almost 65%. And as of 31 December 2015, Alkem has won approval from the US Food and Drug Administration (FDA) for 27 abbreviated new drug applications (ANDAs) for generic drugs and one new drug application. More than 40 other ANDAs have also been submitted to FDA.

An FDA spokesman declined to comment on whether it was collaborating with EMA on its review or on an enforcement action of its own, saying, “As a matter of policy, FDA does not discuss pending or potential enforcement actions except with the firms and individuals who are the subject of those actions.”

Alkem’s Taloja site is not one of the company's six FDA-approved manufacturing facilities.

EMA’s review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), which is responsible for all questions concerning medicines for human use and which will adopt an opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

EMA Review of Alkem Laboratories site


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