5 reflections from MHRA following the Covid vaccine spotlight

“MHRA was under the spotlight during Covid, with vaccine authorisation attracting huge global interest,” reflected Rachel. “It’s hard to take ourselves back to that time.”

But, to the interested attendees at Objective’s RegTech for Government event, Rachel did just that, examining the impact of Covid-19 on regulatory processes and offering some reflections and lessons learned.

The Medicines and Healthcare products Regulatory Agency is an executive agency of the UK’s Department of Health and Social Care, responsible for regulating medicines, medical devices and blood components for transfusion in the UK.

Given the nature of its regulatory role, MHRA was faced with challenges to ensure the continuity of existing clinical trials etc during the pandemic, while leading on the regulation of the Covid-19 vaccine programme in the UK.

What did MHRA do?

Rachel summarised:

1. Ensured continuity of normal business – implemented regulatory flexibilities to ensure clinical trials etc could continue and the remote inspections of manufacturing and packaging designs, avoiding the need for wet signatures.
2. Gave priority to Covid vaccines and potential treatments – clinical trial approval time was reduced from c.19 to 8 days; open offer of early regulatory advice to vaccine developers; and rolling reviews of data took place in real time to cut timelines dramatically.
3. Regulatory development – identified a legal framework for the authorisation of new vaccines (R174 emergency authorisation), and (with DHSC) developed new Statutory Instrument to “back up” its use.
4. Redesigned processes to take place in parallel, rather than sequentially – everything was ready to go by the time the final clinical trial results were available from the first Covid-19 vaccine. The first global authorisation of a Covid-19 vaccine was granted on 2 December 2020.
5. Kept going. Further vaccine authorisations were granted (AstraZeneca 29 Dec; Moderna Feb 21; Janssen June 21 …); Safety surveillance and action was implemented; and booster authorisations were granted.

What did MHRA not do?

“We did not cut corners – we did the same work but in a slightly different order or parallel,” Rachel noted. “We maintained standards despite suspicion that pressure would mean we were cutting corners.”

“We also didn’t compromise our independence.”

Rachel’s 5 reflections

1. We were ready and took early action. The necessary legislation, processes and expertise (people) were in place.
   Trust what you have in place and continue to develop, invest and grow. Be even more ready.
   
2. We laid the ground for the future. The regulatory flexibilities put in place have challenged and developed our practice e.g. remote inspections and avoiding wet signatures.
   Learn and develop practice and regulations – balancing benefit and risk.
   
3. Communication is a key regulatory activity. It was essential we communicated what we were doing and what action we were taking and why.
   Keep that profile and communication going and continue to build knowledge and trust.
   
4. High expectations of regulation now – this presents both a challenge as regulators are needed to meet expectations, and also a real opportunity to see regulation as part of a wider landscape from development to delivery to patient.
   
5. Day job continues – Two year Delivery Plan 2021-23; new Innovative Licensing and Access Pathway launched; new Medicines and Medical Devices Act Spring 2021 …. Multiple authorisations, clinical trials, inspections, enforcement action…
   Business continuity matters, project management matters etc.
   

• Find out more about the Medicines and Healthcare products Regulatory Agency by visiting the website
  

• This presentation was delivered at Objective’s RegTech for Government event. To find out more, visit the event recap page, including key takeaways and resources

Speaker information

Rachel is Deputy Director, Partnerships at the MHRA. She has an extensive career in health policy – both UK national and global health issues. In (then) DFID, she led global health policy and strategy, focussing on health systems strengthening, and supported access to medicines and revision of medicines regulatory system in Sierra Leone. In the UK, she has developed strategy and legislation to improve the care of older people and overcome health/social care boundaries, and worked on various NHS service policies, such as waiting times, transplantation, and HIV/AIDS. In her current role, she has overseen work on the new Medicines and Medical Devices Act 2021 and led MHRA policy on the regulation of Covid-19 vaccines.