Periodic safety update reports (PSUR)

A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorisation.

The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits. This evaluation should ascertain whether further investigations need to be carried out and whether changes should be made to the product information or marketing authorisation.

Examples of sources of efficacy, effectiveness and safety information that may be used in the preparation of PSURs include:

  • data from clinical and non-clinical studies;
  • spontaneous reports (e.g. on the marketing authorisation holder’s safety database);
  • product usage data and drug utilisation information;
  • observational studies, including registries;
  • scientific literature.

The format of the PSUR follows the structure described in the Implementing Regulation Article 35 and Module VII of the Guideline on good pharmacovigilance practices Module VII provides guidance on the preparation, submission and assessment of PSURs. This format is a legal requirement for all products, regardless of the legal basis.

PSUR submissions are not required for all medicinal products, but the need for PSURs is determined using a risk-based approach. Certain products authorized under certain legal basis are exempted to submit PSURs routinely (Article10.1 generic, Article 10a  well-established use, Article 14 homeopathic and Article 16 traditional herbal medicinal products). For such products, PSURs shall be submitted only where there is a condition in the marketing authorisation or when requested by a competent authority.

The PSUR submission frequency is variable. Marketing Authorisation Holders (MAHs) are required to submit PSURs according to the data lock points published in the EURD list.

The EURD list is legally binding.  The EURD list is a living document which will be amended whenever considered necessary by the PRAC, the CHMP or CMDh in response to the emergence of relevant new safety information, newly authorised substances and requests received from MAHs. Substances can be added or removed as appropriate. The EURD list is updated on a monthly basis; MAHs should therefore maintain an awareness of the current status of the list. PSURs shall also be submitted at any time immediately upon request by the regulatory authorities.

PSUR single assessment

The EU legislation introduces the principle of EU single assessment where a substance is authorised in more than one Member State. The single assessment procedure is being implemented in a phased approach and has applied to centrally authorised products since 2 July 2012. Since April 2013, it is applicable for nationally authorised products (incl. products registered through MRP or DCP procedure) when the active substance is also registered as a centrally authorised product. The EU single assessment of PSURs of active substances only included in Nationally Authorised Products is expected to start by the end of 2014. Please see the EMA website for further details.

Until the single assessment procedure is introduced for nationally authorised products, the assessment of PSURs for these products will follow procedures currently in place: EU PSUR worksharing  and purely national procedures.

All PSURs, with the exception of PSURs for products authorised on the basis of Article 58, must be submitted via the PSUR Repository. More information on the PSUR Repository, how to register for the system, and instructions on submissions through the Repository is available on the EMA website.

In addition to facilitate the transitional arrangements of single EU assessment of PSURs, substances under the PSUR Work Sharing Scheme and substances contained in Nationally Authorised Products only with a Data Lock Point falling before until August 2014 are maintained on a separate list. This list is referred to as the 'List of Substances under PSUR Work Sharing Scheme and other substances contained in Nationally Authorised Products with DLP synchronised' and is maintained by CMDh.