EMA published new practical guidance on August 13, 2026 explaining how pharmaceutical companies can participate in pilots where national authorities rely fully or partially on EMA’s assessment of post-authorisation changes.
The potential prize is substantial: fewer duplicated technical reviews and faster global implementation of approved changes.
But reliance does not mean one global approval.
How the Pilot Works
EMA instructs interested companies to contact the agency and provide a high-level description of the proposed pilot and post-authorisation change.
Applicants then engage with interested national authorities.
The company submits the same core material, including the EU variation package, CHMP final assessment report and approval letter, while still satisfying mandatory local requirements.
National authorities remain responsible for their own decisions.
They can rely fully or partially on EMA’s assessment but must operate within their national legal frameworks.
Why This Matters Operationally
The traditional global change process can create an uncomfortable state:
New process approved in Market A.
Old process still required in Market B.
Transition inventory needed for Market C.
Manufacturing then has to maintain multiple configurations because regulatory implementation is asynchronous.
That can complicate:
- batch planning;
- inventory;
- labeling;
- specifications;
- supplier changes;
- validation;
- site transfers;
- ERP master data;
- release decisions.
If reliance shortens the spread between national approvals, lifecycle management becomes easier.
What Companies Still Have to Do
Reliance is not permission to ignore national requirements.
EMA explicitly states that applicants should comply with mandatory local requirements and respect national classifications for post-authorisation changes.
Therefore companies need a clear separation between:
Common technical evidence and Country-specific administrative/regulatory requirements.
That separation itself is a useful process-improvement opportunity.
Expected Timeline
EMA says recommended pilot steps—from engagement through execution—are expected to take no longer than six months, though accelerated national assessments may take less time.
The process includes:
- contacting EMA;
- optional pre-submission meeting;
- engaging national authorities;
- optional kick-off;
- submissions through national procedures;
- authority questions;
- applicant responses;
- independent national decisions.
What Should Global Regulatory Teams Review?
First, identify changes that create significant implementation lag across markets.
Good pilot candidates may include changes where regulatory sequencing creates genuine manufacturing complexity.
Second, map the current country-by-country process.
Ask:
- How much of each dossier is identical?
- What content is genuinely local?
- Which authorities perform essentially duplicate technical assessment?
- How many manufacturing configurations remain open while approvals are pending?
- What inventory cost does that delay create?
That turns reliance from a regulatory concept into a measurable operating model.
An Example :
A company validates a new manufacturing site for a globally marketed medicine.
EMA approves the variation.
Without reliance, the same evidence may then be assessed independently across several jurisdictions.
During that period, the company may need to keep the old site operational for some markets.
Under a successful reliance pilot, participating authorities can use EMA’s technical assessment while making their own national decisions.
The benefit is not simply regulatory speed.
It may reduce the duration of dual-site operational complexity.
Frequently Asked Questions
Does EMA approval automatically approve the change globally?
No. Participating national authorities retain responsibility for their own decisions.
Can countries rely only partially on EMA?
Yes. EMA states that authorities can fully or partially rely on its assessment.
Do local requirements disappear?
No. Companies must still satisfy applicable mandatory local requirements.
How long should a pilot take?
EMA says the recommended steps are expected to take no more than six months, with some accelerated decisions potentially occurring sooner.
What kinds of teams should be involved?
Regulatory CMC, manufacturing, quality, supply chain and lifecycle-management teams should jointly evaluate whether faster synchronized approvals would create operational value.
