Pharmacovigilance lagstiftning - PSUR

Transkript

1 Pharmacovigilance lagstiftning - PSUR Karl Mikael Kälkner Tf enhetschef ES1 EUROPAPARLAMENTETS OCH RÅDETS DIREKTIV 2010/84/EU av den 15 december om ändring, när det gäller säkerhetsövervakning av läkemedel, av direktiv 2001/83/EG om upprättande av gemenskapsregler g för humanläkemedel 1

2 Nyheter PSUR Nytta-risk balans Single assessment URD lista PRAC (Pharmacovigilance Risk Assessment Committee) Nytta-risk balans Sammanfattning och bedömning av preparatets t kumulativa nytta-risk balans Ingen rutinmässig bifogad line listing Ny mall 2

3 Guideline on good pharmacovigilance practices (GVP) Module VII Periodic Safety Update Report Signature Page Title Page Executive Summary Table of Contents 1. Introduction 2. Worldwide Marketing Approval Status 3. Actions Taken in the Reporting Interval for Safety Reasons 4. Changes to Reference Safety Information 5. Estimated Exposure and Use Patterns 1. Cumulative Subject Exposure in Clinical Trials 2. Cumulative and Interval Patient Exposure from Marketing Experience 6. Data in Summary Tabulations 1. Reference Information 2. Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials 3. Cumulative and Interval Summary Tabulations from Post-marketing Data Sources 8. Findings from Non-interventional Studies 9. Information from Other Clinical Trials and Sources 10. Non-clinical Data 11. Literature 12. Other Periodic Reports 13. Lack of Efficacy in Controlled Clinical Trials 14. Late-Breaking Information 15. Overview of Signals: New, Ongoing or Closed 16. Signal and Risk Evaluation 1. Summaries of Safety Concerns 2. Signal Evaluation 3. Evaluation of Risks and New Information 4. Characterisation of Risks 5. Effectiveness of Risk Minimisation (if applicable) 17. Benefit Evaluation 1. Important Baseline Efficacy and Effectiveness Information 2. Newly Identified information on Efficacy and 7. Summaries of Significant Findings from Clinical Trials in the Effectiveness Reporting Interval 3. Characterisation of Benefits 1. Completed Clinical Trials 18. Integrated Benefit-risk Analysis for Approved Indications 2. Ongoing Clinical Trials 1. Benefit-risk Context Medical Need and Important 3. Long-term Follow-up Alternatives 4. Other Therapeutic Use of Medicinal Product 2. Benefit-risk Analysis Evaluation 5. New Safety Data Related to Fixed Combination 19. Conclusions and Actions Therapies 20. Appendices to the PSUR Single assessment En rapport per substans En Rapportör skriver AR PRAC tar ställning Generika slipper skicka in PSUR om inte annat anges (URD) 3

4 Tidslinje för PSUR single assessment 60 dagar 30 dagar 15 dagar URD lista Definierar PSUR period och DLP Period bestäms utifrån riskbaserad bedömning Om substans inte finns på URD lista gäller grundregeln för PSUR period Beskriver även de substanser där generika behöver skicka PSUR PRAC beslutar om listan 4

5 Column Name Column Description Any additional information ID Codes assigned to each active substance and combination of active substances Any comments made should indicate the ID Names of active substances or combination of active substances The names are in English. correspond to terms in EVMPD and former Work Sharing Any comments made should indicate the names. and Synchronisation lists. Date of the first or earliest known date of EU reference dates list [DIR Art 107c (5) (a,b)] the MA of a MP containing the substances PSUR Frequency as determined by EU Regulatory Network on basis of EU reference date and current B/R profile of the substances. marked with PSUR frequencies > 5 years or > 10 years will have their frequency determined at a later stage. Data Lock Point as determined by EU Regulatory Network on basis of EU reference date and PSUR submission frequency of the substances. marked with DLPs 01/01/2025* or 01/01/2030* will have their DLP determined at a later stage - correspond to entries with PSUR frequencies > 5 years or > 10 years. Are PSURs required for Generic medicinal products? whether PSURs for Generic Medicinal products should be submitted to be part of a PSUR single assessment. No PSUR required for Generic MPs except 1) a condition for PSUR submission included in MA, 2)when specified in the list following consideration by a MS (on basis of PhV concern or due to a lack of PSURs for a given active substance). [DIR Art 107b(3)] Flödesschema När skicka PSUR 5

6 Offentlig publicering List of EU reference dates and frequency of submission of PSURs; Final assessment conclusions of the adopted assessment reports; PRAC recommendations including relevant annexes; CMDh position including relevant annexes and where applicable, detailed explanation on scientific grounds for any differences with the PRAC recommendations; CHMP opinion including relevant annexes and where applicable, detailed explanation on scientific grounds for any differences with the PRAC recommendations; European Commission decision. Övergångsregler Single assessment för centrala substanser från juli 2012 PSUR WS fortgår tills vidare Valfritt format till jan 2013 därefter nya PSUR formatet Tills EMA s Repository är i drift skickas PSUR till alla berörda myndigheter. 6

7 Frågor? 7