Keeping track of PSUR deadlines

The Periodic Safety Update Report is one of the central instruments of pharmacovigilance. It is also one of the few where a failure is immediately visible from the outside: the submission is either made or it is not.

Particularly with several active substances, different authorisation regions and staggered data lock points, companies lose track here — not through negligence, but because the dates come from different sources.

The EURD list is the authoritative source. It sets the data lock points and submission intervals per active substance and is updated on an ongoing basis. This also means that an interval that applied at the time of authorisation may change later.

This has an inconvenient consequence for planning — the list must be checked regularly, not just once when the cycle is set up.

For centrally authorised medicinal products the route is comparatively straightforward: data lock point from the EURD list, submission via the central PSUR Repository.

With national authorisations and in procedures involving several Member States, things become less clear, because several authorisations for the same active substance may be covered in different ways. This is exactly where most planning errors arise.

Where deadline planning breaks down in practice:

• The data lock point is treated as a starting signal rather than a cut-off date — data preparation only begins afterwards.
• The EURD list is only checked when the cycle is set up and not again afterwards.
• Acquired marketing authorisations enter an ongoing cycle without the next data lock point having been recorded at the time of transfer.

Managing PSUR cycles systematically protects not only compliance but the operational capacity of the entire pharmacovigilance system: a report produced under time pressure ties up precisely the capacity needed for individual case processing and signal management.