Regulatory/GMP Compliance, Europe

What does the 2024 VPAS mean for pharma?

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

The EC is calling for interested parties for their safety and orphan drug committees.

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

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

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.

The agency is warning patients and healthcare providers about pre-filled pens falsely labeled as Ozempic.

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

Janssen has requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab).

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

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

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

The updated vaccine will be ready to ship following a positive European Commission review.

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.

The indication for Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

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

The framework is now expanded beyond COVID-19 vaccines and treatments.

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.

Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.