Module 5 Presentations

05/07/2024

Additional clarity on other definitions

CTD

CTR

Investigational Medicinal Product (IMP)

‘ investigational medicinal product ’: a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form

‘ Investigational medicinal product’ means a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial The definition is completed by additional entries on: ‘ Normal clinical practice ’ means the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder ‘ Advanced therapy investigational medicinal product ’ [ATMP] means an investigational medicinal product which is an advanced therapy medicinal product as defined in point (a) of Article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council ‘ Auxiliary medicinal product’ [AxMP] means a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product; As well as entries for ‘Authorized’ IMPs and AxMPs

Note: Non IMPs are only described in supportive guidance, not in CTD

Note the change in terminology: NIMPs (CTD) = AxMPs (CTR)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

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Initial Conclusion: Impact on planning to consider

• CTR impact assessment and readiness considerations goesbeyond submission management and needs to be holistic and global

• Positioning your trial in the correct regulatory framework (classification) was, and remains, a critical step for planning, regulatory submission pathways (interplay with other EU regulatory frameworks) and compliance with maintenance requirements

• Important to consider the nuances of each regulatory framework (eventual interplays with other EU regulations and with existing country legislation) for necessaryoperationaladjustments to account for

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

12