EU Pharmacovigilance Strategy: Public consultation on draft legislative proposals

EUDG Enterprise and Industry wishes to consult stakeholders on legislative proposals to strengthen and rationalise the EU system of pharmacovigilance. The Commission services conducted a previous consultation, between 16 March 2006 and 12 May 2006, which sought stakeholders' views on the strengths and weaknesses of the current EU system of pharmacovigilance and how the system could be strengthened. The web-based consultation was supplemented by public workshops in April 2006, as well as, meetings with specific stakeholder groups. The consultation results were made public in February 2007 and at the same time, in response to the consultation outcome, Vice- President Verheugen announced its "Strategy to Better Protect Public Health by Strengthening and Rationalising EU Pharmacovigilance". The Strategy has two parts: 1. better implementation of the current framework and, 2. proposals for change to the legal framework. Details of both the 2006 consultation and the Strategy are available on the Commission's website.

This public consultation specifically addresses part 2 of the strategy, the proposals for changes to the legal framework. This consultation paper is organised in the following sections:

  • Section 1 introduces the consultation, explains how and by when to submit consultation responses and explains the next steps.
  • Section 2 provides a brief orientation on pharmacovigilance and the background to the strategy.
  • Section 3 presents the legislative strategy and the key proposals for legislative change.
  • Section 4 presents detailed proposals to change EU legal texts.
The public consultation is open from 4 December 2007 to 1 February 2008. Stakeholders may wish to comment on the key proposals presented in Section 3 or may prefer to comment on the detailed proposals to change EU legal texts presented in Section 4. All comments should be sent electronically to Dr Peter Arlett by 1 February 2008.

For further information, download PUBLIC CONSULTATION ON LEGISLATIVE PROPOSALS document (.pdf).

Most Popular Now

Therapy using dual immune system cells effectively…

A newly developed immunotherapy that simultaneously uses modified immune-fighting cells to home in on and attack two antigens, or foreign substances, on cancer cells was ...

Cleveland Clinic study suggests steroid nasal spra…

A recent Cleveland Clinic study found that patients who regularly use steroid nasal sprays are less likely to develop severe COVID-19-related disease, including a 20 to 2...

How to develop new drugs based on merged datasets

Polymorphs are molecules that have different molecular packing arrangements despite identical chemical compositions. In a recent paper, researchers at GlaxoSmithKline (GS...

New drug combination effective against SARS-CoV-2 …

More countries with greater resources are opening up for a more normal life. But COVID-19 and the SARS-CoV-2 virus are still a significant threat in large parts of the wo...

Sanofi to focus its COVID-19 development efforts o…

Recent positive interim results of Sanofi's mRNA-based COVID-19 vaccine candidate Phase 1/2 study confirm the company's platform robust capabilities and strategy in mRNA...

Discovery of mechanics of drug targets for COVID-1…

A team of international researchers, including McGill Professor Stéphane Laporte, have discovered the working mechanism of potential drug targets for various diseases suc...

Phase II/III trial shows Ronapreve™ (casirivimab a…

Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive data from the phase II/III 2066 study, investigating Ronapreve™ (casirivimab and imdevimab) in patients hospit...

Pfizer and BioNTech receive first U.S. FDA Emergen…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the P...

AZD7442 request for Emergency Use Authorization fo…

AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) com...

Pfizer and BioNTech receive CHMP positive opinion …

Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the Europea...

Boehringer Ingelheim acquires Abexxa Biologics to …

Boehringer Ingelheim announced the acquisition of Abexxa Biologics Inc., a biopharmaceutical company taking a new approach in the fields of immuno-oncology and oncology r...

GSK welcomes WHO recommendation for broad roll-out…

GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK's RTS,S malaria vaccine to reduce childhood illness and deaths fr...