Periodic Safety Update Reports
Periodic Safety Update Reports (PSURs) are reports providing an evaluation of the benefit-risk balance of a medicine.
PSURs are submitted routinely by marketing-authorization holders to EPVC at defined time points following a medicine’s authorization. They summarize data on the benefits and risks of a medicine and include the results of all studies carried out with this medicine, both in its authorized uses and in unauthorized uses.
EPVC uses the information in PSURs to determine if there are new risks identified for a medicine or whether the balance of benefits and risks of a medicine has changed. and can then decide if further investigations need to be carried out or can take action to protect the public from the risks identified, such as updating the information provided for healthcare professionals and patients.
List of EU reference dates and PSUR submission
PSUR being a global document, EPVC adheres to the European system in PSUR submission. The European Medicine Agency (EMA) maintains a list known as "List of the European Union Reference Dates" (EURD list) which includes a comprehensive list of active substances and combinations contained in medicines along with their corresponding EU reference dates and frequency of submission of PSURs.
The EURD list has been compiled in order to facilitate the harmonization of Data Lock Points (DLPs) and frequency of submission of PSURs for medicinal products containing the same active substance or the same combination of active substances, subject to different marketing authorizations. This allows, where appropriate, the single assessment of the related PSURs.
The frequency of submission of PSURs is designated taking into account the currently known safety profile of the active substances and combinations of active substances, based on risk proportionality.
The list is a living document, i.e. it can be amended whenever considered necessary in response to the emergence of relevant new safety information, newly authorized substances. Substances can be added, but also removed as appropriate.
► List of EMA EU reference dates and frequency of submission of PSURs http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000361.jsp&mid=WC0b01ac058066f910
Contents of the EURD list
The EURD list was first published by EMA in October 2012. It includes the active substances and combinations of active substances contained in medicines, together with:
► the corresponding EU reference dates;
► frequencies for submission of PSURs;
► related data lock points.
The names of the active substances and the combination of active substances are in English and are sorted in alphabetical order.
The EU reference date corresponds to the date of the first marketing authorization of a medicine containing that active substance or that combination of active substances in the EU, or alternatively the earliest of the known dates of the marketing authorizations for a medicine containing that active substance or that combination of active substances. The term “Not available*” is indicated when the EURD is pending.
The Data lock point is the date designated as the cut-off date for data to be included in a Periodic Safety Update Report.
The PSUR frequency and related data lock points for a given active substance or combination of active substances in the EURD came into effect on 1 April 2013. They overrule the submission schedule described in the “Egyptian Guidelines on Pharmacovigilance of Medicinal Products for Human Use for the Marketing Authorization Holders (MAHs)”
The column “Submission date" has been included next to the column “DLP” to support MAHs’ planning in terms of the PSUR submission and ensure that all relevant PSURs are received prior to the start of the assessment procedure.
In addition, the column “Next DLP” has been completed for active substances or combination of active substances with a PSUR frequency of up to 6 months. This is again to support predictability for stakeholders in terms of PSUR-related activities.
Updates made to the EURD list as adopted by the EMA are highlighted in order to facilitate the review by stakeholders.
The column “Publication date” refers to the publication date of changes related to the PSUR submission frequency and/or DLP for a given active substance or combination of active substances.
PSUR submission timelines
Each marketing authorization holder in Egypt shall be responsible for submitting PSURs for its own products to EPVC according to corresponding DLPs & frequencies published in the latest version EURD list, the PSUR submission date is calculated based on the following submission timelines:
► within 70 calendar days of the data lock point (day 0) for PSURs covering intervals up to 12 months (including intervals of exactly 12 months); and
►within 90 calendar days of the data lock (day 0) point for PSURs covering intervals in excess of 12 months;