Module 6

04/10/2024

Synchron Research Services

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

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A UK view of compliance?

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has historically had concerns about clinical trial data integrity. 1. Wockhardt : In 2013, the MHRA suspended the manufacturing license of Wockhardt’s facility in India due to concerns about data integrity and Good Manufacturing Practice (GMP) compliance. This led to the recall of several medicines from the UK market. 2. Ranbaxy : In 2014, the MHRA suspended the importation of medicines from two of Ranbaxy’s Indian manufacturing sites. The decision was based on data integrity issues and non-compliance with GMP standards.

The Organisation for Professionals in Regulatory Affairs

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