Regulatory/GMP Compliance, Europe

Kapruvia (difelikefalin) has been granted approval by Swissmedic as a treatment for moderate-to-severe pruritis associated with CKD.

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

EMA has accepted the marketing authorization application for an oral fixed-dose combination treatment as an initial treatment for adults with AML.

A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.

A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.

A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.

The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.

MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.

NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

EMA has been assigned a formal role in preparing for and managing future public health crises within the EU through the formalization of ad-hoc structures and processes that were employed during the COVID-19 pandemic.

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.

On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation.

In January 2022, Europe started to implement EU-CTR, a new regulatory framework for clinical trials, but what does this mean for pharma clinical research?

Pharma’s interest in decentralized clinical trials (DCTs) increases as it helps to expand their geographical reach and racial diversity

EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.

Continuous improvements in technologies and services will help cold chain operators meet future industry demand.

The UK’s National AI Strategy underpins the government’s long-term commitment and ambitions to enhancing the country’s digital ecosystem, with the health and life sciences sectors seen as pivotal contributors to meeting these aims.

EMA has recommended granting a marketing authorization in the EU for Kimmtrak (tebentafusp), a new medicine for a rare type of eye cancer.

EMA has recommended approval of Spikevax for children aged 6 to 11.

MHRA has opened a consultation on the proposed changes to clinical trial legislation in the UK.

Guidance published during the pandemic has been updated to include content requirements for summary safety reports.

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.