Cancer Research UK attacks draft EU medicine guidance
EFPIA also raises concerns
Cancer Research UK has criticised European Commission draft guidance for non-investigational medicinal products (NIMPs) in clinical trial authorisation (CTA) submissions, claiming it could make some tests ‘unworkable’.
The organisation warns in formal consultation documents that the guidance does not make appropriate allowances for trials in high morbidity diseases where patients will inherently be receiving a vast array of treatments (established and experimental), often over a considerable period of time. It says the guidance is too inflexible on this point and suggests if it is implemented, cancer trials will become unworkable.
Cancer Research also claims the guidance fails adequately to define NIMPs. ‘The definitions are vague and, most worryingly, may have unintended implications for cancer trials,’ it said.
In addition, Cancer Research says the document is repetitive and from a reader’s perspective, not straightforward to follow. It argues that it fails sufficiently to distinguish between the different types of sponsors of tests – notably pharmaceutical companies and universities or hospitals.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) also raised concerns about the guidance in its consultation note to the EC.
While the body ‘welcomed the initiative to create harmonised guidance [on] clinical trials in Europe where differing [European Union] member state requirements remain,’ there were ‘apparent inconsistencies or a lack of clarity.’
Notably, the EFPIA said: ‘There appears to remain confusion between NIMPS and IMPs [investigational medicinal products] in the absence of a formal legal definition of the former.’
Without this, the EFPIA fears test sponsors could be asked to define materials as IMPs where, for example, ‘they are being used in unapproved indications, or are repackaged’.
It also called for further clarification or examples of information required for safe and effective use in non-EU countries.