News briefs

Published: 1-Oct-2005
Regulatory


A public consultation exercise has been launched by the European Medicines Agency (EMEA) on a draft guideline over the pharmacovigilence for medicines used by babies, children and young people aged up to 18. The agency is grappling with European Commission concerns that more than 50% of medicines used to treat children are prescribed on an unlicensed or 'off-label' basis, because they have not been adequately tested, formulated and authorised for them. The EMEA guideline would be used to help companies implement incoming EU regulation on pediatric medicines, as well as toughening the monitoring of adult medicines. The consultation closes on 31 January 2006.

www.emea.eu.int/pdfs/human/phvwp/23591005en.pdf

The European Commission has published guidance over staging consultations with target patient groups or checking the readability of packaging leaflets. http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/08_05/USERTESTING_20050 817.pdf

The European Medicines Agency (EMEA) has released a guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins. www.emea.eu.int/pdfs/human/ewp/8924904en.pdf

EMEA has also released a guideline on the processing of (marketing authorisation) renewals in its centralised procedures (www.emea.eu.int/pdfs/human/regaffair/299000.pdf

And it has released a guideline on how to choose non-inferiority margins when testing a medicine's effectiveness compared with existing drugs.

www.emea.eu.int/pdfs/human/ewp/215899en.pdf.

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