It’s been a difficult year for many biopharma companies and perhaps even more so for clinical research organisations, with Covid-19 forcing the postponement or even cancellation of many if not most clinical trials. It is however important to keep a finger on the pulse of the other imminent regulatory changes that will impact work programmes in this industry. In my last blog in this series (Orphan Unknowns: What the MHRA Guidance Will Mean After Brexit ) I highlighted things to watch out for in the Orphan Drug sphere in light of current Brexit transitions.
This year, with clinical trials expected to get under way again – thanks to the speed with which vaccines are being developed and approved — attention is again turning to the EU’s new Clinical Trial Regulation. The regulation has been delayed several times due to technical issues with the new EU Clinical Trials Portal and Database, but has recently been confirmed for implementation in December 2021, so it needs to be back on the radar of the Clinical Trials industry.
While there will be a transition period, and trials already under way can continue through the Clinical Trials Directive (CTD), there is a lot of work for companies to do to meet the CTR. Biopharma companies should be conducting impact assessments by now, because there could be months of remediation work that will have to be carried out to get up to speed with the regulation.
Sponsors outside of the EU will face more scrutiny with regards to their quality management systems. It’s important, therefore, to ensure staff have been properly trained on quality requirements and to instill a culture of compliance. That must come from senior quality people, and it will require well-structured processes and systems that take into account the regulations in all areas where the company is operating or plans to operate. Being inspection ready at all times will become imperative under the CTR, since EMA has made clear that their audits will be more vigorous.
There are a lot of nuances to a well-structured quality management system, so it’s important to have someone in-house – or work with a consultant — with a good understanding of the requirements. This person will need to bring that knowledge into the company and educate everyone on how their role impacts change control systems, corrective and preventive actions (CAPAs), and overall compliance. Sponsors will need to ensure your staff know the processes for reporting CAPAs and that your processes are properly designed and followed. Is their team members know the standard operating procedures? Do they know how to report anything that happens outside the CAPA systems? And are those properly managed?
Sponsors will also need to demonstrate clear decision-making processes when it comes to vendor selection. Are they auditing your vendors and CROs? Are they conducting proper feasibility studies? Are they asking the right questions? And how often are they independently monitoring CROs and research associates?
While the CTR affects all companies conducting trials in Europe, it creates more complexities for companies based outside of the EU that may not be used to working within the remit of EU regulations. Having a strong European partner on the ground in the EU who really understands these issues, can help you get up to speed and can enable you to build compliance into your organisation, will be even more important in future.
To help you stay abreast of such regulatory changes our Regulatory On-Call service provides personalised responses to your ad hoc regulatory enquiries by way of a monthly retainer, get in touch for more information. Also look out for the subsequent blogs in this series relating to Medical Device and General Data Protection Regulations; work programmes that have not gone away but may have drifted from focus in the current environment.