Module 5 Presentations

05/07/2024

Synchron Research Services, India (2019)

• 14.1.2022 FDA informs about the outcome of GCP inspection that identified several issues at Synchron Research Services, indicating that the company was responsible for creation of false data. • Similar concerns have been previously raised in two EU inspections (FR&NL in 2005, and DE in 2009). Data from these studies have been rejected, but these cases were treated as isolated non-compliance.

Approved name

Semler

Reference number

EMEA/H/A-31/1515

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

CHMP opinion

Opinion date

19/05/2022

EC decisiondate

28/11/2022

https://www.ema.europa.eu/en/medicines/human/referrals/sync hron#key-facts-section

The Organisation for Professionals in Regulatory Affairs

69

Synchron Research Services, India (2019)

https://www.ema.europa.eu/en/medicines/human/referrals/sync hron#key-facts-section

The Organisation for Professionals in Regulatory Affairs

70

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