Mar 5, 2020
Following the conclusions from EMA (European Medicines Agency) referral as regards bacterial lysates and PSUSA procedure, this month we’re talking to Mrs Christine Delbes, Pharmacovigilance Manager of Lallemand Pharma, about this procedure and the safety of medicines.
1. Bacterial lysates have run PSUSA procedure at the level of European Medicine Agency (EMA), could you please describe this procedure, and the role of EMA?
C.Delbes : “Periodic Safety Update Report Single Assessment (PSUSA) is a procedure run by the Pharmacovigilance Risk Assessment Committee (PRAC) – at the European Medicines Agency’s (EMA) committee responsible for assessing and monitoring the safety of human medicines – on the basis of the requirements set up in the list of European Union Reference Dates (EURD) list.
The EURD list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorizations, together with the corresponding EU reference dates, frequencies for submission of periodic safety update reports and related data lock points. The EURD list is a legally binding document and provide a list of active substances and combinations of active substances that are subject to assessment at European level. MAHs are legally responsible for complying with its requirements and must submit Periodic Safety Update Reports (PSUR).”
2. What was the outcome and conclusion of PSUSA for Polyvalent Mechanical Bacterial lysates?
C.Delbes : “Following the assessment of the PSUR (PSUSA/00001582/201712) of the PMBL sublingual tablets (Active substances: haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes / streptococcus viridans vaccine), the PRAC has concluded for the maintenance in Europe of the terms and current product information of the marketing authorizations in Europe of PMBL sublingual tablets.”
3. Does this procedure warrant the safety of medicines?
C.Delbes : “PSURs are pharmacovigilance documents, those reports are a comprehensive, concise and critical analysis of the benefit/risk balance of medicinal product, taking into account new or emerging information in the context of the cumulative information on the risks and benefits. Their purpose is to determine whether there are new risks or whether risks have changed or whether there are changes to the benefit/risk balance of medicinal products.”
4. Is it mandatory for all drugs to pass the PSUSA procedure, and what is the periodicity?
C.Delbes : “The PSUSA procedure is mandatory for all active substances and combination of active substances listed in the EURD list, that are authorized in Europe and that are subjected to different marketing authorizations.”
5. Is the rule the same for food supplements, herbals and natural products?
C.Delbes : “The PSUSA procedure only concerns medicinal products.”
6. In conclusion, could you please briefly describe the role of Pharmacovigilance Manager?
C.Delbes : “The pharmacovigilance by definition is a science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem, it is therefore an activity contributing to the protection of patients’ and public health. The exercise of Pharmacovigilance is regulated, basically the Pharmacovigilance (PV) Manager role is to set up and maintain a PV system in accordance with the regulations in forces and Good Pharmacovigilance Practices (GVPs).”