Sean Milmo

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.

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

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.

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.

Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.

The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.

The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.

The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.

The repercussions of EMA’s relocation and Brexit will continue to be the dominant regulatory issue throughout 2018.

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.

The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.

Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.

The pharmaceutical industry now braces itself for the consequences and complexities that could follow in the wake of the United Kingdom’s decision to leave the European Union.

The impact of pharmaceutical manufacturing on the environment has triggered demands for tighter environmental controls in EU and national legislations.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.