Hoe gaat de overheid hiermee om? Wat zijn de overwegingen? Wanneer wordt bijv. besloten tot verkorting van de PSUR cycle

wetgeving Council regulation 2309/93 540/95 Directive 75/319 as amended

System for drug surveillance (National pharmacovigilance centre) for receipt and evaluation of all pharmacovigilance data within that Member State

The CA as part of its obligation to undertake ongoing evaluation of risk benefit assessment, must ensure that all pharmacovigilance data received and outlined are taken into account on an ongoing basis

Individual adverse reaction reports Periodic Safety Reports Company Sponsored Post Authorisation Safety Studies Pharmacovigilance data from other sources

Objective: provide an update of the world wide safety experience The regulatory authorities regard the PSURs as important summaries and analyses of drug safety data

With a focus on all serious and non serious unlisted adverse events they can prove a valuable source of drug safety signals The accumulation of all clinical safety data from all relevant sources provides an excellent opportunity to carry out an overall safety evaluation of the product

PSUR European PSURs follow the format and content for safety updates as ICH E2C requirements European authorization National authorization

Waarde van de PSUR Kwaliteit Mening registratiehouder Spontane meldingen

Waarde van de PSUR Causality assessment Underreporting Vulnerabilty to external events

overemphasis on rare ADRs

Aandachtspunten ICH E2C Cyclus Summary Bridging rapport CCDS

Instrumenten:  Aanpassen SPC  Verandering cyclus  Closely monitoring

Toekomst ICH E2E Eudravigilance database Work sharing

Surveillance Describe patterns of occurrence Identify unusual events Provide early warnings Track trends

wetgeving Volume 9 ICH E2C ICH E2E

Major issue spontaneous data Draw conclusion from inaccurate data At best provide a signal At worst eschew patients form beneficial therapies.

Fatal ADRs are between the fourth and the sixth leading cause of death

Some ADRs are understood recognized and accepted as necessary side effects to achieve desired benefit

Purpose of surveillance Describe patterns of occurrence Identify unusual events Provide early warnings Track trends

Spontaneous reports are the major source In the US 90% are submitted by the MAHs Drawbacks

Estimates are imprecise ADRs are a major public health problem