Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA), the procedure has posed a number of challenges that are specific to the assessment of nationally authorised medicinal products.
The following explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the PSUSA process.
Ultimately, the explanatory note will serve as the basis for the update of GVP Module VII, which will eventually replace it. It should be noted that, as appropriate, points highlighted in this document may also apply to the assessment of centrally authorised products.
This note should be read in conjunction with GVP Module VII; where appropriate, references to ICH E2C (R2) are made; it should be used for the preparation of PSURs subject to single assessment. In order to preserve the content that is agreed by international consensus, all European Union (EU) specific information should be provided in the EU regional appendix of the PSUR (GVP Module VII section VII.C.5.).
The document is divided into sections identifying the key issues for the development of further guidance. Throughout the explanatory note, the product information (PI) refers to the EU PI. Recommendations made in this paper are aimed at limiting the number of issues and requests for clarification, which are raised during the assessment period, given the time constraints of the procedure.
Marketing authorisation holders (MAHs) may consider training on ICH E2C (R2) guideline and the ICH E2C Questions and Answers (Q&A) developed by the ICH-E2C (R2) Implementation Working Group (IWG)