European Regulatory Watch

Inspecting GMP at a Distance

December 02, 2020

The success of virtual GMP inspections performed during the pandemic may lead to more flexible opportunities in the future.

COVID-19 Stresses EMA Resources

November 02, 2020

The agency is balancing a variety of important issues including the review of COVID-19 vaccines.

Regulating with Flexibility: The Pandemic Effect

October 02, 2020

Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

Regulations Under Regular Review

September 02, 2020

The 2020–2025 EMRN strategy will be regularly reviewed over the coming five years to accommodate science and technology advances.

Tackling Serious Impurities

August 02, 2020

EU regulators are requesting more effective action be taken to tackle serious impurities in APIs and finished products.

Business on Hold? EMA’s Full Recovery in Question

July 02, 2020

EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.

A Strategic Shake Up in Europe’s Medicines Sector

June 02, 2020

The EU’s pharmaceutical strategy has the potential to shake up the policies and regulations of the region’s medicines sector.

Can EMA’s Regulatory Science Strategy Meet Medicine’s Major Challenges?

May 02, 2020

EMA’s strategy for regulatory science has divided opinion amongst various industry bodies.

Learning Lessons in Crisis Management

April 02, 2020

Regulatory emergency planning has been put to the test with the COVID-19 pandemic.

Playing Catch Up with Big Data in Europe

March 02, 2020

EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.