EU periodic safety update report synchronisation scheme and work sharing

Afssaps

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Drugs
29/04/2009

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• DRUGS

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• Publié par: ansm-drugs
• Publié le: 29 avril 2009
• Nombre de lectures: 43
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: English

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INTRODUCTION

EU PERIODIC SAFETY UPDATE REPORT SYNCHRONISATION SCHEME AND WORK SHARING

M aria B oulos   (1) , a nnaBelle P age   (1) , C arMen K reft -J aïs   (1) (1) Département de pharmacovigilance, Afssaps

A European initiative has been undertaken to ensure that medicinal products authorised through national and Mutual recognition/ Decentralised procedures with the same active substance, follow the same periodic safety update report (PSUR) submission scheme in all European Member States. The purpose of this initiative is to share the PSUR assessment workload throughout the EU in order to minimise duplication of work for stakeholders

OBJECTIVES

➢ Outline this new initiative related to the pharmacovigilance assessment of PSURs. ➢ Enlighten some of difficulties raised regarding this project and discussions led at the European level in order to find solutions.

METHODS AND RESULTS EU Harmonised “virtual” Birth Dates (EU HBDs), related Data Lock   Points (DLP) for the forthcoming PSURs and allocated PSUR Reference Member State (P-RMS) have been set by mutual agreement between Member States and the MAH. In 2007, a list of 600 substances included in the PSUR WS was published on the HMA website. This list (Figure a) was updated in March 2009 with additional substances (over 1800 substances).

Allergens, parenteral products and medicinal gases were excluded from this project. Thereby, for products with the same active substance, the same PSUR should be submitted to all Member States where the company holds a marketing authorisation. The P-RMS issues an assessment report taking into account any safety information addressed in the innovator and generics PSURs. A core safety profile (CSP) is approved for all the member states. SPCs and package leaflets are then updated according to this CSP. Although no legal framework requires following the EU PSUR schedules, most of the innovator and generic industries participate to this project. Indeed, ➢ For pharmaceutical firmsthat have to deal with different PSUR submission schemes for products approved through national or European procedures, the work sharing allows to simplify submission of PSURs and to avoid duplication of work that may affect the quality of the reports. ➢ For national competent authorities (NCA) responsible for the assessment of products with the same active substance but with different birth dates, the work sharing permits to achieve the best use of resources and to deliver an update safety profile per active substance.

DISCUSSION Several issues are raised within this work sharing project and need to be discussed at the European level. One of the major concerns currently under discussion, is the content of the CSP and the implementation of this CSP at national level.

PSUR WORK SHARING LIST UPDATE MARCH 2009 – [EU Harmonised Birth Dates (EU HBDs), related harmonised Data OLock Points (DLPs), allocated PSUR Reference Member States (P-RM)]

Active substance name (INN) [18 F] Fludeoxyglucose (Injection) 123 i-Mibg 131 i-Mibg 17-Alpha-Oestradiol (Topical) 17b- Estradiol + Trimegestone 99 mo/ 99 Tc (Tc Generator) Abciximab Acamprosate Acarbose Acebutolol Aceclofenac Aciclovir Acipimox Acitretin Acrivastine + Pseudoephedrine Adapalene (Topical) Adenosine Albendazole Aldesleukine Alendronate Alfentanil Alfuzosin Alizapride Almagate Almotriptan Alprazolam Alprostadil (Erectile Dysfunction)

CONCLUSION

Innovator brand name  EU HBD  Next DLP (for f p i r x o e d d  u c ct o s  m o b n i l n y) ation  (year and month) Firm’s Name 20021028 200811 Schering AG 19950131 201001 Ge Healthcare 19910601 200905 Ge Healthcare 19960226 200902 Galderma Int. Totelle 20000922 200903 Wyeth 19830601 200905 Ge Healthcare 200911 J&J 19870724 200807 MerckKGA 19900331 200903 Bayer 19771031 200912 Sanofi Aventis 19900319 200803 Almirall / UCB 19810610 200906 GSK 19761208 200912 Pfizer 19871201 200910 Roche Duact 19901231 200912 GSK 19920703 200707 Galderma Int. 19910814 200908 Sanofi Aventis 19810710 200707 GSK 19890703 200812 Novartis 20001110 200801 MSD 200909 J&J 19871112 200911 Sanofi Aventis 19790109 200801 Sanofi Aventis 19820122 200905 Almirall 19991224 200806 Almirall 19800312 201003 Pfizer 19840128 201101 Pfizer/Schwarz Pharma

Comments A P l r l o o c c e a d t u e r d e     P n - u R m M b S e   r /  pr D o a c y e   d 0  u o r f e  Date pr A e R liminary Date D A r R aft final Da w t i e t   h F   i C na S l P  AR  Modified PSUR cycle RM pr S  o f d or  c M t RP  u s FR/H/PSUR/0016/001 27.02.2009 HU/H/PSUR/0020/001 DK/H/PSUR/0046/001 DE/H/PSUR/0034/001 SE/H/PSUR/0021/001 SE BE/H/PSUR/0013/001 UK/H/PSUR/0019/001 UK IE/H/PSUR/0011/001 20.02.2009 ES/H/PSUR/0006/001 DK/H/PSUR/0026/001 IE/H/PSUR/0008/001 15.08.2008 24.02.2009 DK/H/PSUR/0035/001 DK/H/PSUR/0028/001 DK/H/PSUR/0024/001 DK/H/PSUR/0027/001 IE/H/PSUR/0001/001 01.10.2007 31.10.2007 20.02.2008 IE UK/H/PSUR/0055/001 UK PL/H/PSUR/0006/001 NL/H/PSUR/0018/001 NL AT/H/PSUR/0007/001 26.05.2008 04/07/2008 09.01.2009 PL/H/PSUR/0014/001 SE/H/PSUR/0033/001 SE BE/H/PSUR/0004/001 03.04.2008 13.05.2008 02.06.2008 ES/H/PSUR/0007/001 ES/H/PSUR/0008/001 14.10.2008 06.11.2008 yearly PSURs ES FR/H/PSUR/0036/001 UK/H/PSUR/0020/001 01.05.2008 09.06.2008 16.07.2008 UK

(Fig. A)

Alternative Brand Names

For the time being, PSUR work sharing seems to be an interesting initiative but many questions need to be answered before this project becomes of a real benefit. The competent authorities will have to deal with these issues promptly since the new legislation related to pharmacovigilance forecasts a legal framework for these PSURs, making the work sharing mandatory. It is to be noted that the initiative of European work sharing is being developed for other procedures (variation, paediatric evaluation, clinical trials …).