Direct national route
Applicants planning an initial marketing authorisation, new-indication variation or line extension should notify the MHRA at least three months before submission.
UK REGULATORY READINESS · SOURCE-LINKED
See the regulatory clock before it becomes a delivery risk.
Peptide Readiness monitors the route, notice period, assessment timetable and decision boundary around innovative peptide and biological medicine programmes.
Current boundary
This service monitors published regulatory processes. It does not authorise a medicine, predict an MHRA decision, establish NICE recommendation or create NHS access. Official MHRA guidance remains controlling.
MHRA UPDATE · 16 SEPTEMBER 2026
Three process changes now tracked.
The update applies across innovative medicines, including all biological medicines. It is a portfolio-level readiness change, not a molecule-status change.
International Recognition Procedure
Applicants using the IRP route should notify the MHRA at least eight weeks before submission and follow the route-specific process.
Clock-on day outcomes
The innovative-medicines procedure targets a positive decision within 150 clock-on days where issues are resolved after one question round, and a final decision within 210 clock-on days where issues remain.
Type II variation decision point
The 120-day procedure provides for approval or one Request for Further Information at Day 90. After refusal, an applicant may request written or oral representations to the CHM within the stated deadline.
MHRA TYPE IA GUIDANCE · REVIEWED 30 SEPTEMBER 2026
Post-authorisation annual updates
For Type IA changes implemented from 15 January 2026, the first change generally starts an annual-update cycle. Changes that do not require immediate notification are generally bundled by UK marketing authorisation and submitted no earlier than nine months and no later than twelve months after the oldest implementation date, subject to the MHRA’s stated exceptions. This is a lifecycle-submission requirement; it does not change medicine authorisation, clinical status, NICE recommendation or NHS access.
Read the current MHRA variation guidanceADJACENT SERVICE · AI & EVIDENCE GOVERNANCE
Track the policy. Keep the product boundary clear.
AI and evidence-governance readiness monitoring is a separate, adjacent Peptide Readiness service: source-linked briefings on policy milestones, evidence provenance, lifecycle oversight and adoption responsibilities. It does not change the status of any molecule in the database.
UK healthcare-AI policy · 6 October 2026
The UK Government accepted all 44 recommendations of the National Commission into the Regulation of AI in Healthcare. MHRA will develop a more proportionate, lifecycle-based framework for AI-enabled medical devices, including post-market monitoring and guidance on adaptive changes. A full implementation roadmap is expected by spring 2027.
Policy direction, not product approval. This announcement does not authorise a medicine or device, establish a NICE recommendation or determine NHS access. Peptide Readiness is positioned as a professional information service; it does not diagnose, recommend individual treatment or provide clinical decision support. Any future change in functionality requires its own regulatory assessment.
THE MONITORING LAYER
From published process to an auditable readiness view.
A maintained chronology keeps route, timing, evidence, health-system coordination and commercial consequence separate.
MONITORED FIELD
Submission route
Direct national, International Recognition Procedure and other applicable UK routes are kept distinct.
MONITORED FIELD
Advance notice
Planned submission dates, notification windows and any MHRA pre-submission meeting requirement are made visible.
MONITORED FIELD
Assessment clock
Clock-on days, requests for information, clock-stops and decision points are tracked without converting a timetable into an approval forecast.
MONITORED FIELD
MHRA–NICE coordination
Operational information-sharing requirements are separated from NICE assessment, recommendation and NHS access.
MONITORED FIELD
Indication changes
Type II variation milestones, information requests and review rights are monitored separately from initial authorisation.
MONITORED FIELD
Post-authorisation lifecycle
Type IA annual-update windows, implementation dates and immediate-notification exceptions are tracked against current MHRA guidance.
MONITORED FIELD
Commercial exposure
Process changes are translated into planning, governance and launch-readiness questions without making clinical claims.
PEPTIDE INTELLIGENCE SERVICE LINE
Regulatory and lifecycle-readiness monitoring.
Source-linked monitoring of submission routes, variation milestones, Type IA annual-update windows and notification exceptions for regulatory affairs, clinical governance, market access and innovation teams.
Regulatory intelligence only. Not legal, regulatory, clinical or treatment advice. Verify the current official source before acting.