Quality Systems

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Articles

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.

Enhanced Role of EMA in EU Crisis Response

Cheryl Barton is director of PharmaVision, 

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

In-Vitro Diagnostic Regulation

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland. 

Swissmedic Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine

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?

Regulating Clinical Trials

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.

An Overview of the UK’s National AI Strategy

The Digital Markets Act is transforming the use of digital content by the pharmaceutical industry.

Updated Guidance to the EU’s Digital Markets Act

DTx manufacturers are taking advantage of the new regulatory flexibility, afforded by the COVID-19 pandemic, to pilot new products and generate real-world evidence to support regulatory filing and reimbursement.

Regulating Digital Therapeutics

Sean Milmo is a freelance writer based in Essex, UK.

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

Adapting Regulations Post-Brexit

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

Getting Tough on Supplies

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

European Regulatory Watch