Clinical trials in the UK are regulated by The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) as amended. These regulations implement Directive 2001/20/EC (‘The Clinical Trials Directive’)
A clinical trial is an investigation in human subjects which is intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. According to the Clinical Trials Directive, clinical trials of medicinal products in human subjects requires authorisation by the competent authority (MHRA in the UK) and a favourable opinion by an ethics committee. This authorisation is granted in the form of a clinical trial authorisation (CTA).
In order for an application to be considered as valid, a submission should contain a file for each of the following documents:
- Covering letter
- Clinical Trial Application + valid xml
- IB or document replacing the IB
- IMPD/simplified IMPD
- NIMP Dossier (if required)
- Scientific advice – A summary of scientific advice from any Member State or the EMA with regard to the clinical trial (if available).
- EMA Decision – A copy the EMA’s Decision on the decision of the Paediatric Investigation Plan and the opinion of the Paediatric Committee (if applicable).
- The content of the labelling of the IMP (or justification for its absence)
- Proof of payment
- Manufacturer’s authorisation or Importer’s authorisation plus QP declaration on GMP for each manufacturing site.
Cell2TherapyTM have extensive experience in creating CTAs, obtaining their approval and appropriately ammending them as situations and trials develop.