Regulatory/GMP Compliance, Europe

EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine

July 24, 2023

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

EU Takes Steps to Prevent Antibiotic Shortages Next Winter

July 20, 2023

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

EMA Reviews GLP-1 Receptor Agonists for Self-Harm Risk

July 13, 2023

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

Europe Phases Out COVID-19 Flexible Regulations

July 06, 2023

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.

COVID-19 Vaccine, Nuvaxovid, Gains EU Approval

July 06, 2023

Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.

Top 10 Considerations when Meeting with Regulators

July 02, 2023

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.

Improvements to EMA’s PRIME Designation Scheme

July 02, 2023

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

EMA Overhauls the Medicine Legislative and Regulatory Framework

June 02, 2023

What implications will EMA’s recent regulatory reform have on pharma?

NICE Gives Nod to Kapruvia for Moderate-to-Severe CKD-Associated Pruritus

May 18, 2023

UK’s NICE has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.

AbbVie Gains Access to UK Crohn’s Disease Market with NICE Recommendation

May 18, 2023

UK's NICE has recommended RINVOQ (upadacitinib) as a treatment option for adult patients in England and Wales with moderately to severely active Crohn’s disease.