In May the MHRA presented a webinar regarding the new RegulatoryConnect portal. A recording of the webinar is available on the MHRA website.
The MHRA goals for RegulatoryConnect are that it will provide more predictable regulatory pathways, with greater transparency and visibility for regulatory assessments to industry. What this means is that the portal access will allow users to log in and:
- track the status of an application and view what stage it is at.
- view live authorisation details, including status, key data and existing licence documents.
The next RegulatoryConnect portal update will be from Q2 2026, when Industry will be able to submit and manage their Product Licenses via the portal.
The below table provides the next steps planned by the MHRA for the roll out of RegulatoryConnect.
Changes we will see – Portal administration:
- RegulatoryConnect portal will become the single place to make Human Medicines regulatory submissions (not applicable for PV submissions)
- Users must register using individual mailboxes, rather than group mailboxes
- at least two admins will be required, to create the organisational accounts and provide the portal access for your organisation. Admins will manage user permissions
- Existing RegulatoryConnect portal users will have their accounts migrated
Changes we will see – Submission preparation:
- Regulatory services application form (eAF) will be 100% digital format
- eCTD sequences to be uploaded directly to RegulatoryConnect
- You must maintain your organisational details on the portal
Changes we will see – Submissions:
- Only route for submission in the UK
- Submissions by CESP or Intralinks no longer possible
- Fees must be paid before work will start, either on invoice receipt or at submission – status is visible in the portal
- Risk-proportionate regulation will be enabled for some variations
- SPC fragments no longer required
Changes we will see – Validation and approval:
- Main method of communication with applicants for updates, status and receiving/sending RFI
Key points to know:
eAF – The eAF will be a web-based version within RegulatoryConnect. Currently there will be no way of importing an EU eAF in EU PLM Portal into the RegulatoryConnect portal, although its something they will look at in the future. The form can be saved in draft and can be saved as PDF to allow review/comments.
UK CMS in MR/DCP – Where UK are a CMS, CESP will not be possible for UK submission. Therefore submission to the UK as CMS must be through RegulatoryConnect.
PV – PV submissions will continue through SafetyConnect.
The MHRA want comments, feedback and interaction from Industry during this development process, so please provide your input.
