Sean Milmo

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?

The current fragmented regulatory approach to cannabis medicines across Europe is challenging to harmonize.

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.

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.

EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.

Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.

Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.

How involved should HTA bodies be in assessing cost effectiveness and reimbursements?

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