Brussels abandons pharma information reform proposals

Published: 18-Jun-2014
Regulatory

Does not receive enough support from EU Council of Ministers


The European Commission has abandoned attempts to secure approval for a comprehensive reform of European Union (EU) rules on pharmaceutical information – after failing to secure sufficient support from the EU Council of Ministers.

Its proposed regulation and reforms to directive 2001/83/EC – tabled in 2008 – would have created rules on how pharma companies can disseminate information about their products and how this should be monitored by EU member states.

Having decided it could not gain approval, the Commission has now withdrawn the proposals as 'good legislative management'. The proposals had, however, been approved by the European Parliament, the EU’s other co-legislative body.

See more

You may also like

Manufacturing

Signal Group launches MCERTS approved VOC emissions monitor

Read more
New SOLAR CEMNEX analyser offers advanced compliance and connectivity features

Trending Articles

  1. Douglas Pharmaceuticals sets new benchmark for capsule quality with CI Precision Partnership delivers compliance confidence, efficiency gains and reduced waste
  2. Balancing innovation and accessibility in amino acid testing Butterworth Laboratories expands analytical capabilities to support compliance with Ph. Eur. standards
  3. You need to be a subscriber to read this article.
    Click here to find out more.
    Quality management during manufacturing changes: part I Change is a universal constant and continues to accelerate in the realms of pharmaceutical, medical device and in-vitro diagnostic manufacturers who face ever-increasing pressure to optimise costs while maintaining high product quality and patient safety standards
  4. NICE recommends enfortumab vedotin with KEYTRUDA for adults in England/Wales with untreated metastatic urothelial cancer The results from the Phase III study EV-302/KN-A39 showed nearly a doubling of survival rates in patients compared with those who received platinum-based chemotherapy, which is the current standard of care in the UK
  5. FDA makes groundbreaking decision to waive clinical efficiency studies for monoclonal antibody biosimilars The University of Illinois secured the first-ever FDA acceptance to waive clinical efficiency studies (CESs) for the biological drugs

Upcoming event

Enhancing probiotic stability through smarter formulation and packaging strategies

18 September 2025 | Virtual See all

You may also like

Manufacturing

Signal Group launches MCERTS approved VOC emissions monitor

New SOLAR CEMNEX analyser offers advanced compliance and connectivity features
You need to be a subscriber to read this article.
Click here to find out more.
Packaging

Cloud labelling and serialisation: the new frontline of traceability in drug delivery

As drug delivery evolves to accommodate a new wave of data-driven innovation, the need for traceability and compliance throughout the supply chain is paramount. Innovative cloud-based solutions enable pharmaceutical companies to navigate these demands with confidence
Regulatory

Novo Nordisk’s oral semaglutide scores EU approval for cardiovascular benefits

Rybelsus is now the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke
Manufacturing

Douglas Pharmaceuticals sets new benchmark for capsule quality with CI Precision

Partnership delivers compliance confidence, efficiency gains and reduced waste
Regulatory

New NICE thresholds: good news for rare disease drugs but process remains complex

Recent changes introduced by NICE will ultimately see more ultra-rare disease drugs get to market, but Dan Williams, CEO at SynaptixBio, says the process remains challenging
Manufacturing

Balancing innovation and accessibility in amino acid testing

Butterworth Laboratories expands analytical capabilities to support compliance with Ph. Eur. standards
You need to be a subscriber to read this article.
Click here to find out more.
Manufacturing

Quality management during manufacturing changes: part I

Change is a universal constant and continues to accelerate in the realms of pharmaceutical, medical device and in-vitro diagnostic manufacturers who face ever-increasing pressure to optimise costs while maintaining high product quality and patient safety standards
Subscribe now