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How to prepare for oral explanations with EMA

A marketing authorisation application (MAA) can take up to 210 days in which EMA experts spend time to assess the information provided by the applicant which supports their MAA. This period can be interrupted by ‘clock-stops’ where EMA’s Committee for Medicinal Products for Human Use (CHMP) can raise questions that the applicant must address. Oral explanations occur during clock-stop period and can be requested by the applicant or CHMP.

An oral explanation is a presentation and question-and-answer session in person between representatives of an applicant and a European Medicines Agency committee. It forms an important part of the step-by-step evaluation for the medicines that are intended for EMA approval. It tends to be organized when the CHMP still has significant objections regarding the application; the applicant must provide clarifications on the committee’s issues. The EMA recently issued a guidance document to applicants/marketing authorization holders (MAHs) for oral explanations. The document’s aim is to provide the practical guidance that applicants may need for oral explanations and/or discussion meetings.

Preparing for the oral explanation

  • EMA contact point shall confirm the timeslot for the oral explanation no later than 7 working days in advance.
  • The maximum number of participants allowed for oral explanations is 12.
  • The applicant company must provide EMA with a list of the participant details no later than 2 working days in advance. This includes the following details:
    • First name, last name, email address, phone number, affiliation, role in oral explanation.
  • If several applicant/MAH groups are involved in a particular procedure they must divide themselves in order to provide a single oral explanation for an identified issue.
    • This group composition should be shared with EMA no later than 2 working days in advance of the meeting.

An electronic version of the final presentation must be shared with EMA no later than 2 working days before the oral explanation. EMA shall not admit non-listed participants in the meeting.

Conducting an oral explanation

  • Chairperson invites the company’s representative to introduce themselves and give their presentation. An EMA rep displays and navigates the company’s presentation.
  • Company presentation must not exceed 20 minutes. It should focus on relevant scientific evidence that has been submitted and the company’s position with respect to the issues that have been identified. No more than 2 or 3 speakers should be associated with each 20-minute presentation. A Q&A session follows the presentation.
  • Once the oral explanation has been concluded, the company representatives leave the plenary meeting. EMA committee and working parties continue with further discussions.
  • The rapporteur/coordinator and EMA provides feedback once the scientific discussion is over.

What happens after an oral explanation?

During the oral explanation stage, CHMP or associated members (including members of a committee or working party) that lead the application evaluation may recommend consulting with a working party for certain questions/issues. Or the committee may call for other experts such as healthcare professionals by way of scientific advisory group or ad-hoc expert group meeting. They may be asked to answer specific questions related to the clinical use of the medicine. The chair of the group may then report back to the committee on the discussion outcome.

CHMP, rapporteurs, and co-rapporteurs may assess and evaluate the revised information that the applicant provides after obtaining the responses to the outstanding issues and discussions during oral explanations. The assessment report and the risk management plan are updated accordingly.

Conclusion

Oral explanations are important for applicants as they provide them the platform to address any concerns that EMA/committees have with MAAs for their products. Applicants must ensure they prepare and provide the required and necessary information in order to ensure a smooth oral explanation that would support their MAA. It is recommended to frequently communicate with EMA and partner with experts that can support the applicants with the required information.

DDReg, as a leading regulatory consulting organization, has 5+ years of experience with stringent regulatory authorities, like EMA and has supported its customers for successful filings in Europe. Reach out to our team to support you with your upcoming oral explanation with EMA.

References and Further Reading