We are delivering cutting-edge technology to improve processes, introduce automation and enhance customer services throughout 2018.
Our Information Processing Unit is in the middle of a four-year reform programme designed to improve its services, operations and overall efficiency while harnessing new technology to deliver improved value to both our internal and external stakeholders.
While driving forward our reform activities we continue to meet our day-to-day service levels.
Improved processes – you asked, we delivered
IPU has responded to customers’ requests to work more collaboratively during the application validation process by delivering a new feature known as a Validation Correct Request (VCR) for variation applications.
Between December and January we successfully completed a VCR trial with a number of companies and we are now rolling this out more widely. This new functionality is initially available on Type 1B and Type II variations with plans in place to roll this out to more work types in the near future.
The old system involved submitting your variation application to MHRA to be validated against regulatory requirements as set out in the guidelines before it could be passed on for assessment. Any minor deficiencies could result in the application being rejected and the applicant having to start the process again.
The new functionality allows us to issue a VCR which will provide customers with the chance to resolve minor issues during the validation process. If a minor deficiency is identified customers will be issued with a VCR letter which will detail the issue, for example, “missing SPC fragments”. There will be 48 hours given to provide the requested information. Failure to provide this information in the given time would result in automatic invalidation of the application. The application would then have to proceed as previously, in other words, starting the submission process again.
The VCR feature will mean time is saved, the process is more efficient and customers avoid losing fees.
If you have any queries or concerns, please contact: IPUScientificValidation@mhra.gov.uk.
Introducing automation
Adopting new robotic processing technology to automate the significant amount of manual and repetitive tasks we carry out each day will be the unit’s largest and most complex project to date. This is good news for the team and our applicants as it will mean faster end-to-end validation times and round-the-clock acknowledgements. The project is still in development with delivery planned in phases throughout 2018.
Over the coming months as the reform programme develops, we will be looking to encourage best practice in the industry in areas such as improving the visibility of our national requirements and e-submission timelines on gov.uk. Make sure to keep up to date and sign up to our MHRA gov.uk notifications.
Enhanced customer services
We have been reviewing how we manage our current engagement through our mailboxes, identifying better ways of addressing queries and of surveying our customers to target improvements.
Over the coming months we will be streamlining our points of contact in IPU to provide a “one stop shop” approach with a dedicated team on hand to answer queries. As we continue to seek better ways of working we will also be improving our guidance to industry in ‘getting it right first time’.
Watch this space for more to come!
Read our previous blog, (July 2017) to understand more about how MHRA’s Information Processing Unit operates as the main submission hub for the Agency, receiving regulatory applications relating to Marketing Authorisations and Clinical Trial applications for medicinal products.