Pharmaceutical companies with large medicinal product portfolios can apply to attend a portfolio and technology meeting (PTM) with EMA.
These meetings can:
They are free-of-charge and held virtually.
EMA publishes two calls for applications each year.
The first call, which EMA publishes in September, invites applications for meetings scheduled in the first half of the following year.
The second call, which EMA publishes in March, invites applications for meetings held in the second half of the year.
You can find an overview of the application timeline below.
Applying for a meeting
The applicant completes the application form.
EMA reviews it and confirms whether the meeting is granted within 6 weeks.
Sending the briefing document
If the meeting is granted, EMA asks the applicant to complete and send a briefing document 4 to 6 weeks in advance via Eudralink.
The briefing document template is available in the section right below.
Sending a presentation
The applicant provides a presentation one week before the meeting.
Preparing the draft meeting report
Applicants prepare a draft meeting report within 10 working days outlining the topics discussed and outcomes. They should send it via Eudralink to EMA.
The meeting report template is available in the section right below.
Finalisation of the meeting report
EMA reviews the draft meeting report within 10 working days and provides the final version via Eudralink.
The required templates are available below.
Portfolio and Technology Meetings (PTM) cover topics related to the development of innovative medicines.
They aim to:
Applicants can only submit applications when the call for expression of interest is open.
Participants are subject matter experts from EMA. EMA provides the preliminary list of EMA participants 2-3 days before the meeting.
EMA typically schedules these meetings in the afternoon to suit various time zones.
The meetings are virtual and last 90 minutes. There is no limit to the number of participants.
Applicants provide the topics for discussion by completing an online application form. This can be done when the call for expression of interest is open on the EMA website.
No. However, applicants can request a change, which EMA will deal on case-by-case basis.
EMA grants meetings based on the topics provided in the online application form.
EMA selects the members of the expert panel based on the proposed topics and sets the meeting date. It assesses any changes individually.
The following topics are examples of topics discussed at these meetings:
In this section of the application form, EMA would like to gather applicants’ perspectives on topics of particular interest to regulators, regardless of the proposed topics for discussion during the PTM.
EMA will consider the provided information in a holistic manner and use it to support horizon scanning, resource planning, and to future-proof the regulatory network.
If, for any reasons, applicants choose not to reply, EMA kindly asks for a brief explanation.
The views expressed in the meetings are the opinions of participants and may not reflect the opinions of EMA’s scientific committees.
Participants should interpret the answers provided as preliminary scientific and regulatory considerations of the information presented. These answers do not constitute regulatory guidance or review recommendations for any applications.
We recommend phrasing your topics according to the examples provided below:
EMA provides the applicant with the meeting report template including the final list of participants.
EMA requests the applicant to draft the meeting report within 10 working days, detailing the topics discussed and the outcome of the discussions.
The draft meeting report is circulated for comments to EMA participants, reviewed by the coordinator and the final version of the meeting report is sent via EudraLink back to applicants within 10 working days.