OpenLobby.EU
Explore

Shionogi Europe B.V.

SBV

Shionogi Europe is the European Headquarters of the global pharmaceutical company Shionogi & Co Ltd based in Osaka, Japan.

Lobbying Activity

Response to Performance of pharmacovigilance activities for human medicines ( update of Implementing Regulation (EU) 520/2012)

14 Jan 2025

Preamble 5: () the requirements for marketing authorisation holders should be clarified (). --Further clarification on what is expected from MAH is welcome. Shall it be expected in a revision of GVP Module IX? Preamble 7: () minimum reporting requirements should apply in all cases --There does not seem to be any significant change in the minimum reporting requirements in the amended regulation (Art. 28). We are expecting clarification on reportability/not reportability of second-hand information and additional emphasis that one of the minimum requirement is an Adverse Reaction (not an Adverse Event). Will clarification be included in a revision of GVP Module VI? Preamble 9: () that report should include updates on the implementation of risk minimisation measures --This clarification is unnecessary. GVP module VII already asks to add a paragraph on Effectiveness of risk minimisation. If a RMM has been implemented or not is already regularly discussed in this paragraph. This change to Article 34 is merely semantic. Will we expect additional clarification in a revision of GVP Module VII? Preamble 10: If national competent authorities, the Agency or the Commission have concerns about the safety of a medicinal product, they may oblige a marketing authorisation holder to initiate () non-interventional post-authorisation safety studies --We would suggest further clarification in the amended regulation. It should be made clearer that for Centrally Approved Products, the Agency only should require PASS studies to be run. It would also be helpful if the conditions and terms for allowing this obligation were clearly set out and that everything is addressed in the frame of the RMP. Will it be expected in an amendment of Art. 36 and/or in a revision of GVP Module V? Article 1 Item (2) - Replacement of the Article 4, paragraph 3: Any significant deviations from the pharmacovigilance procedures, their impact and their management shall be documented (). --significant deviations should be further defined. Article 1 Item (3) Addition of paragraph 3 to Article 6: 3. () (d) This paragraph applies mutatis mutandis to the third parties that subcontract the tasks subcontracted to them by the marketing authorisation holder. --We understand that MAHs would be entitled to audit the vendors of their partners. This is welcomed although it should be noted that this may complicate risk-based audit planning if non-contracting MAHs are expected to capture them in their own risk-based audit strategy. Article 1 Item (3) Addition of paragraph 4 to Article 6: 4. Third parties shall not subcontract any pharmacovigilance task assigned to them by the marketing authorisation holder without the marketing authorisation holders written consent. --In some circumstances, interpretation might not be straightforward. For example, if a MAH subcontracts the hosting of their Global Safety Database to a vendor, this latter might have many subcontractors involved in such task to some extent. Shall the MAH approve all of them? And based on what criteria should MAHs approve or reject a certain subcontractor considering that they do not qualify them? Article 1 Item (5) Amendment of Article 13: (a) 1. Marketing authorisation holders shall perform regular audits of the quality system at risk-based intervals (). The audits shall cover all pharmacovigilance activities for a defined period () --It should be clarified if MAHs shall declare in advance the timeframe under audit scope and cannot audit records falling outside this timeframe? Article 1 Item (9) Deletion of paragraph 2 in the Article 21 --Deletion of paragraph 2 raises concerns. It implies that, if the MAH identifies a signal in EudraVigilance, it cannot be entered in the PSUR until it is validated by EMA, which may delay the communication/analysis of the signal. This is not in the interest of patients. Commission should provide more explanation on why paragraph 2 is deleted.
Read full response

Meeting with Laurent Muschel (Acting Director-General Health Emergency Preparedness and Response Authority)

4 Dec 2024 · Pipeline presentation

Meeting with Aurelijus Veryga (Member of the European Parliament)

20 Nov 2024 · The most pressing health challenges currently confronting the EU

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

19 Nov 2024 · AMR

Meeting with Karsten Lucke (Member of the European Parliament)

5 Jun 2023 · PAIS / R&D