EMA and WHO are supporting a pilot programme that enables pharmaceutical companies to submit EMA-approved post-authorisation changes (i.e. variations) to multiple non-EU national authorities.
These pilots allow national authorities to use EMA's assessments to reach their own regulatory decisions. This happens almost simultaneously with the related post-authorisation changes. It is called a concurrent review.
National authorities keep full scientific and regulatory independence in their decision-making.
Pharmaceutical companies take the initiative to start a pilot.
As of February 2025, there are 10 ongoing pilots involving up to 100 national authorities. They mostly cover major quality-related post-authorisation changes that can impact the supply of medicinal products.
For more information, see:
Pilot objectives
The reliance pilots aim to accelerate review and approval timelines. They do so by exploring relevant regulatory pathways, in line with WHO's good reliance practices.
They also aim to:
- facilitate patient access to quality-assured medicines;
- make better use of resources;
- help authorities align on regulatory requirements, also referred to as convergence;
- improve transparency between the pharmaceutical industry and regulatory authorities, and among regulatory authorities.
Regulatory authorities use reliance extensively when they approve medicines. However, they do not apply reliance widely to assess post-authorisation changes. These changes can be complex, time-consuming and unpredictable, which increases the risk of shortages.
Insights and recommendations from these pilots will help achieve a more efficient global model based on standardised reliance practices to assess post-authorisation changes. This will benefit both regulatory authorities and the pharmaceutical industry.
For more information, see:
How to apply for pilots
EMA invites pharmaceutical companies interested in participating in a pilot to contact EMA at emainternational@ema.europa.eu.
Applicants must submit the same documents to all participating national authorities, as indicated below:
- Variation package, as used in the EU
- EMA's Committee for Medicinal Products for Human Use (CHMP) final assessment report and approval letter
Applicants can also submit a question-and-answer document. It should contain an overview of the pilot and details about the post-approval changes. If applicable, it can also cover any information on good compliance practices.
They should comply with mandatory local requirements and respect the classification of post-authorisation changes set by each participating national authority.
National authorities have the option to fully or partially rely on EMA's assessment. They must still adhere to their own regulatory and legal frameworks.
They should also try to align country-specific requirements to EMA's documentation requirements.
Early dialogue and clear communication between the applicant and national authorities is key for the success of a pilot.
Pilot steps
The timeline below describes the recommended steps of a pilot.
The steps can be split into two phases:
- Engagement - where applicants present a pilot to national authorities
- Execution - where the national authorities assess the post-authorisation changes and make their decision
These steps are expected to take around 6.5 months.
Applicant interested in a pilot contacts EMA
Applicant should provide EMA with a question-and-answer document detailing the pilot's steps
Applicant engages with national authorities
Applicant checks the interest of national authorities in participating in the pilot
Kick-off meeting between applicant and national authorities (optional)
National authorities receive information on the pilots and post-authorisation changes
Applicant submits documentation to all national authorities per their regular submission processes
Applicant shares the same documentation to all national authorities, including variation package, EMA assessment report, approval letter, questions and answers, and good manufacturing practices certificate (if needed)
National authorities review submitted documents and ask questions to the applicant
National authorities share their questions with the applicant. They can also ask EMA for clarifications on its assessment report
Applicant replies to the questions from national authorities
Applicant can optionally share responses to all received questions with all national authorities, who can use it to support their own reviews.
National authorities make their independent decisions
Approval or refusal of post-authorisation changes
Pilot metrics
There are a few important metrics that applicants should collect to evaluate the performance of a pilot. Find them below:
- Country engagement - which countries were involved in a pilot, percentage of countries that accepted to participate and reasons for countries not wanting to join a pilot
- Level of reliance - whether national authorities can recognise EMA's assessment or whether they need additional scientific evaluation
- Time - how long did national authorities take to approve the post-authorisation changes
- Level of harmonisation - how many additional changes the applicant made to their dossier to comply with local requirements
- Potential resources saved - both time and human resources needed to manage the post-authorisation changes submitted
EMA role
If required, EMA can hold pre-submission meetings to discuss a pilot.
If needed, it can also:
- attend a pilot's kick-off meeting alongside WHO - in these meetings, applicants provide national authorities with details on the post-authorisation changes, timelines and pilot logistics;
- offer national authorities the opportunity to seek clarifications on its assessment report from the team that produced the report and the rapporteur;
- provide applicants with an invitation letterwhich they can share with interested national authorities;
Furthermore, EMA supports the pilots with other activities, including:
- informal discussions with applicants to discuss the pilots and high-level principles of reliance;
- ad-hoc updates on the progress of the pilots;
- discussions in relevant platforms on lessons learned, ways forward and reliance models.