Non-Investigational Medicinal Products in CTAs: Results published of Public Consultation
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A set of answers has been published by the EU Commission on the public consultation on the draft guidance - Requirements for non-investigational medicinal Products (NIMPD) in Clinical Trial Applications (CTA).
Eight European Associations, Federations and Authorities (including Germany's BfArM) and three pharmaceutical companies have responded to the public consultation on the draft guidance - Requirements for non-investigational medicinal Products in CTA Submissions.
Some of the major ambiguities correspond to tasks like:
The use background and rescue medication without MA. In addition, there are inconsistencies in the different categorisations applied to NIMPs used as background therapy/rescue medications compared to challenge agents.
Simplified NIMPDs (they should be allowed in case the sponsor has previously submitted CMC information to an EU member state either in a marketing authorisation application or in an IMPD/NIMPD which have been granted in that member state)
Distinguishing between the different types of sponsors (pharmaceutical company/drug manufacturer or a university/hospital which has no involvement in the manufacture or distribution of IMPs)
In general, there appears to remain confusion between NIMPS and IMPs. It is unclear what a NIMP is, since the definitions are vague. This may also have unintended implications for cancer trials
The role of the QP
Other concerns are expressed regarding:
The consequences if the NIMPs do not comply with the guideline. Do same consequences apply like for IMPs?
Non-compliance of applicants with ranking list
Insufficient pharmaceutical quality of NIMP. Statements relating to the requirements to ensure GMP compliance are unclear.