Clinical trials and delivery in post-Brexit times

Clinical trials and delivery in post-Brexit times

The pharmaceutical industry has faced numerous challenges since the beginning of 2021 including the rush to supply COVID-19 vaccines. The start of the year also saw the departure of the UK from the EU and the European Medicines Agency (EMA). The Medicines and Healthcare Products Regulatory Agency (MHRA) is now fully in charge of all regulatory matters, oversight of clinical research and approval of medicines. This change has had the following consequences.

Innovations in clinical trials: 

  • Sponsors still need to register clinical trials in a publicly available database before starting but the registries are different now.
  • For a study conducted in UK sites only, it will be the ISRCTN registry
  • Trials involving EU countries must be registered in the EU Clinical Trials Register. 
  • All results must be published in the relevant register after the end of the clinical trial.
  • For UK-based clinical trials, the sponsor or legal representative of a clinical trial will be required in the UK or one from an approved EU/EEA country list.

New drug registration procedures and conditions of importation:

  • The new set-up has resulted in many new customs procedures, rules of origin certification, and disciplinary checks. 
  • This requires changes to supply chain management and additional control over delivery times. Suppliers are now advised to have an extra 6-week supply
  • Clinical trials involving EU/EEA markets will require the addition of the EU/EEA IMP release site to be included via a substantial amendment. That is currently performed by the UK IMP release site only
  • A  new requirement has been set up for investigational medical products (IMPs) used in the UK clinical trials if an EU/EEA manufacturer provides those products. The sponsor will have 12 months from January 1st, 2021, to ensure that a UK MIA(IMP) holder puts up an assurance system to confirm each IMP batch has been certified by a QP before releasing to the trial. All data should be submitted to the MHRA for "supply chain oversight."

Impact on Northern Ireland:

  • Northern Ireland legislation remains in line with EU legislation and will comply with the EU requirements for medicinal products and medical devices;
  • In the UK, marketing authorisations (MAs) registered via the EU Centralised procedure will be transferred to a GB National licence but will remain applicable in Northern Ireland. 
  • Delivery of supplies from the EU to Northern Ireland via Britain must therefore comply with all customs rules and regulations of the EU and Britain. 
  • New customs inspections at Northern Ireland ports are regulated by both standards to ensure that all products meet agreed regulatory requirements. 
  • In the longer term, these requirements could duplicate efforts by manufacturers and traders operating in the UK and Europe, which could lead to increased costs.
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