Module 5 Presentations

05/07/2024

CRO GVK Biosciences, Indie (2015)

• 2014 French Competent Authority (ANMS) performed inspection of CRO GVK Biosciences in India. • The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years. • GVK Biosciences: European Medicines Agency confirms recommendation to suspend 700 licences over flawed studies.

Approved name

GVK Biosciences

Reference number

EMEA/H/A-31/1408

Article 31 referrals This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Type

Status

European Commission final decision

Opinion date

21/05/2015 16/07/2015

EC decisiondate

The Organisation for Professionals in Regulatory Affairs

https://www.ema.europa.eu/medicines/human/referrals/gvk-biosciences

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Semler Research Centre, Indie (2016)

• 20.6.2016 FDA informs about the outcome of GCP inspection that identified several issues at Semler’s bioanalytical site, including the substitution and manipulation of subjects’ clinical samples. • On 21 July 2016, the European Medicines Agency recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India.

Approved name

Semler

Reference number

EMEA/H/A-31/1443

Article 31 referrals This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Type

Status

European Commission final decision

Opinion date

21/07/2016

EC decisiondate

22/09/2016

The Organisation for Professionals in Regulatory Affairs

https://www.ema.europa.eu/en/medicines/human/referrals/semler

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