European Medicines Agency issues draft guidance on data integrity
The European Medicines Agency and the Pharmaceutical Inspection Co-operation Scheme have released draft guidance for pharmas on how to maintain data integrity during testing, manufacturing, packaging, distributing, and monitoring of medicines. Jaclyn Jaeger reports.
Related articles
-
ArticleNavigating HHS and FDA’s overhaul of the food and beverage industry
Under the Trump administration, the Department of Health and Human Services and the Food and Drug Administration have been hellbent on eliminating synthetic food dyes from food and beverage products, forcing a jarring and costly overhaul with cascading impacts on the operations of the entire industry.
-
ArticleRetailers face new compliance pressures from tariffs, sanctions, fraud and cybercrime
Regulators are pressuring retail compliance teams on supply chains, shifting sanctions and tariffs, sustainability, and digital commerce. Rising cyberattacks heighten data security concerns, while large retailers push legal and commercial requirements down their supply chains.
-
ArticleCompliance should prepare for more ESG reporting as global pressure rises
Most major organizations are not changing their ESG reporting plans, despite “regulatory ambiguity”, according to a report by consultancy KPMG. The researchers say this indicates market expectations are driving action as much as legal requirements.