EMA seeks comments on revised global GCP guideline

Published: 21-Sep-2015
Regulatory

Updates encourage more efficient clinical trial design


Pharmaceutical companies in the European Union have been asked by the European Medicines Agency (EMA) to comment on revised good clinical practice (GCP) guidance released by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

The changes encourage more efficient clinical trial design, conduct, oversight, recording and reporting.

See more

You may also like

Regulatory

FDA US Agent services, backed by former regulators and global expertise

Read more
If you’re a medical device company based outside the US, appointing a US Agent is more than just an FDA requirement — it’s a critical part of your regulatory success

Trending Articles

  1. Next expansion milestone achieved: SCHOTT Pharma opens production facility in Serbia to strengthen competitiveness in Europe After a double-digit million euro investment and less than 1.5 years of construction, SCHOTT Pharma opens new manufacturing site in Jagodina, Serbia. Production capacity to meet European market demand for pharmaceutical ampoules. Facility brings around 180 new jobs to the region
  2. You need to be a subscriber to read this article.
    Click here to find out more.
    NICE approval is not enough: why the UK’s next medicines challenge is operational delivery A medicine is not truly accessible until it can be manufactured, procured, stocked, prescribed, dispensed and delivered reliably. That distinction is becoming increasingly important, says Varun Cruz, founder of NEUVIOR
  3. FDA Form 483 flags falsified records and live bird infestation at Dabur India OTC plant A FDA inspection report issued in January 2026 has revealed widespread CGMP failures at Dabur India's Dadra and Nagar Haveli facility, including manipulated microbiology data, fraudulent equipment logs and unsanitary storage conditions
  4. Safety in pharmaceutical manufacturing: why a trusted partner makes all the difference By taking a three-tiered approach to protecting patients and personnel and ensuring plant compliance, GEA adopts a consultative approach to helping its customers navigate the responsibilities of pharmaceutical manufacturing safety with confidence
  5. AMR Bio urges US policymakers to make infection prevention a core AMR strategy Submitted ahead of PACCARB's 27th public meeting, AMR Bio's recommendations call for topical antimicrobials such as MRSA-active XF-73 to receive federal support alongside conventional antibiotic development

Upcoming event

BIO International Convention

22–25 June 2026 | Convention | Boston, US See all

You may also like

Regulatory

FDA US Agent services, backed by former regulators and global expertise

If you’re a medical device company based outside the US, appointing a US Agent is more than just an FDA requirement — it’s a critical part of your regulatory success
Regulatory

AMR Bio urges US policymakers to make infection prevention a core AMR strategy

Submitted ahead of PACCARB's 27th public meeting, AMR Bio's recommendations call for topical antimicrobials such as MRSA-active XF-73 to receive federal support alongside conventional antibiotic development
Manufacturing

Safety in pharmaceutical manufacturing: why a trusted partner makes all the difference

By taking a three-tiered approach to protecting patients and personnel and ensuring plant compliance, GEA adopts a consultative approach to helping its customers navigate the responsibilities of pharmaceutical manufacturing safety with confidence
You need to be a subscriber to read this article.
Click here to find out more.
Regulatory

NICE approval is not enough: why the UK’s next medicines challenge is operational delivery

A medicine is not truly accessible until it can be manufactured, procured, stocked, prescribed, dispensed and delivered reliably. That distinction is becoming increasingly important, says Varun Cruz, founder of NEUVIOR
Regulatory

What to expect from a regulatory inspection: An NSF expert guide

Prepare with confidence. NSF’s expert guide shows what inspectors look for, common pitfalls and how to ensure lasting inspection readiness
Manufacturing

Next expansion milestone achieved: SCHOTT Pharma opens production facility in Serbia to strengthen competitiveness in Europe

After a double-digit million euro investment and less than 1.5 years of construction, SCHOTT Pharma opens new manufacturing site in Jagodina, Serbia. Production capacity to meet European market demand for pharmaceutical ampoules. Facility brings around 180 new jobs to the region
Manufacturing

Bruker announces major strides in 4D proteomics performance, further advances In intact and top-down functional proteoform analysis, and innovations in hybrid qual/quant 4D metabolomics

All to enable deeper insights into disease biology. Bruker Also Launches Two Novel Mass Spectrometry Systems for Unique Applications in Energy Industry Research, and in Semiconductor Manufacturing
Subscribe now