Module 5 Presentations

18/07/2024

History of Legislation:

• Eudralex: 10 volumes in total

• Volume 4: GMP for human and veterinary medicinal products

– Annex 13: Manufacture of Investigational Products

– Annex 16: Certification by QP and Batch Release

• Volume 10: Clinical Trial legislation and guidance

The Organisation for Professionals in Regulatory Affairs

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Recent Legislation changes:

Clinical Trial Regulation 536/2014

• Effective date changed to 2019 due to technical issues. • Replace the CT Directive 2001/20 which was too open to different interpretation across Member States. • CTA Applications will be made through a single EMA portal with the content harmonized. • Introduction of low-intervention trials where the IMP has an MA and use is per the MA and based on standard treatment • No possibility of opting out of expiry date labelling • Transitional IMP QPs need to undertake an assessment

The Organisation for Professionals in Regulatory Affairs

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