EMA industry platform meeting discusses improvements to centralised medicine procedures

Potential improvements to post-marketing authorisation procedures used for pharmaceuticals in the European Union (EU) have been identified in a European Medicines Authority (EMA) survey.

They included establishing better alerts when regulatory guidance is updated; the timeliness of responses from EMA’s pre-submission queries service (PQS); proactive communications in case there are delays in EMA assessment reports and product information comments, opinions and notifications; and the need to optimise the EMA periodic update safety report (PSUR) process.

Despite these concerns, more than 90% of survey respondents rated EMA post-authorisation questions and answers as clear and addressing applicants’ needs. As a result, the agency’s pre-submission queries service (PQS) is not used by the majority of market authorisation applicants. Also, more than 90% of respondents were satisfied with their overall interactions with the agency.

The survey also found that 90% approved of the quality of EMA’s new single assessments reports.

The survey was released at an Industry Platform meeting held at EMA’s London headquarters – the agency has released a report on its proceedings, which included the launch of the survey results.

The meeting focused on the EU’s centralised market approval system, which is run by EMA. Topics discussed included labelling, with agency officials stressing they are willing to advise on suggested changes to company house style for labels. They also said EMA would allow flexibility regarding label and package leaflet wording and layout for generic products; and the agency said it would 'take steps to reflect more transparently the timelines of mock-ups review during an accelerated assessment'.