Six top tips for how to submit a successful clinical trial application in the UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA), yesterday, updated examples of mock investigational medicinal product dossiers (IMPDs) on its website. This inspired us to pull together some helpful hints on preparing a clinical trial application (CTA).
- Use MHRA’s online algorithm to determine if a CTA is required – https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/317952/Algothrim.pdf
- Obtain a EudraCT number – https://eudract.ema.europa.eu/eudract-web/components/eudractnumber/eudractNumber.faces?showHome=false
- Register with Common European Submission Portal (CESP) and make your submissions via CESP. Register at – https://cespportal.hma.eu/Account/CompanyRegistration
- Ensure your submission package is complete and contains:
- A covering letter
- A completed clinical trial application form in PDF and XML versions
- The study protocol
- The investigator’s brochure (IB) or equivalent
- The investigational medical product dossier (IMPD) or a simplified IMPD
- A non-investigational medicinal product dossier (if required)
- A summary of scientific advice received from any national competent authority or the European Medicines Agency (EMA)
- Manufacturer’s authorisation, including the importer’s authorisation and Qualified Person declaration on GMP for any non-EU manufacturing site
- A copy of the EMA’s decision on the paediatric investigation plan (PIP) and the opinion of the paediatric committee, if applicable
- The investigational medicinal product (IMP) labelling.
- Ensure your IMPD meets the required standard. As mentioned above, the MHRA has very recently updated examples of mock IMPDs so use these as a guide- https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk#history
- Get it right first time by:
- Checking the ‘”Common errors at validation” section on the MHRA website to avoid any unwanted delays at validation stage – https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/317989/Common_errors_seen_at_validation.pdf
- Looking at the “Common issues identified during clinical trial applications” to avoid delays during assessment – https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications.
And not making the same mistakes as others!