European Regulatory Watch

The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

The recently published European pharmaceutical strategy is being seen as an opportunity to strengthen medicines regulation in the region.

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

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

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

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

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

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

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

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

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

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.

The UK and Europe are entering a transitional period, which will involve negotiations across the board, including those on the pharma regulatory landscape.

In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.

Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.

Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.

A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.

EMA is seeking ways to improve the effectiveness of its PRIME scheme, so that scientific innovations and new technologies more readily lead to novel medicines.

European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.

Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.

The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.

Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.

This coming year could see a combination of regulatory uncertainty and inactivity for the pharma industry, mainly as a result of Brexit.

EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.

Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.

A European task force outlines its upcoming efforts to combat drug shortages.

The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.