European Regulatory Watch

The European pharma industry needs to be prepared for the new clinical data requirements.

Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

The EHDS aims to increase access to health data, but how will it impact pharma?

What does the 2024 VPAS mean for pharma?

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.

The new framework will position the UK as an attractive prospect for new medicine manufacturers.

The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

What implications will EMA’s recent regulatory reform have on pharma?

A strategy on cyber resilience for health and social care organizations has been set out by the UK government.

Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.

Stepwise paediatric investigation plans aim to boost the development of medicines for children.

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.

A new unified initiative for patent protection in the EU to boost the competitiveness of the pharma industry is nearing completion.

Does the new regulatory framework have the potential to incentivise R&D investment in rare diseases?

The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?

The DGA seeks to increase trust in data sharing, strengthen mechanisms to make data more available, and overcome obstacles to the reuse of data, which are vital ingredients to the intersectoral use of health data.

Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.

A new unitary patent system is due to come into effect in Europe later on this year.

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

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

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.

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

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

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?

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.

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

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.