EMA releases advice on updating information on authorised medicines

Published: 13-Feb-2014
Regulatory

From June to December 2014 marketing authorisation holders must refile medicines data


The European Medicines Agency (EMA) has advised pharma companies on updating the information held by regulators on their authorised medicines.

EMA said that from 16 June to 31 December this year, marketing authorisation holders must refile information on their medicines using a new data submission format, bring information up to date and check information against updated reporting requirements.

See more

You may also like

Regulatory

EMA issues positive opinion on Calliditas' orphan drug

Read more
Calliditas' application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome has received a positive opinion from European Medicines Agency

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

Regulatory

EMA issues positive opinion on Calliditas' orphan drug

Calliditas' application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome has received a positive opinion from European Medicines Agency
Distribution

Moderna receives positive opinion from the EMA for Spikevax

Moderna has revealed the European Medicine's Agency (EMA) has provided positive opinion on its COVID-19 vaccine Spikevax's marketing authorisation
Regulatory

EMA celebrates 25 years of regulatory management

The EMA was founded in January 1995
Regulatory

EMA publishes draft guideline on quality requirements for DDCs

The latest document focuses on combinations of medicinal products and medical devices
Regulatory

GMP inspection in Bulgaria and Cyprus now on par with US

A mutual recognition agreement between the EU and the US regulatory bodies aims to encompass all EU member states, now standing at 24 of the 28
Regulatory

Brexit update: UK Inspection Reports and GMP Certificates

The ECA Academy sheds light on the latest Brexit guidance documents released by the European Medicines Agency
Regulatory

Poland and Slovenia join EU-US mutual recognition agreement for inspections

GMP drug plant inspections conducted by health authorities in Poland and Slovenia will now be accepted by the US FDA
Subscribe now