Regulatory Oversight

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

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.

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.

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?

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

UK’s NICE has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.

UK's NICE has recommended RINVOQ (upadacitinib) as a treatment option for adult patients in England and Wales with moderately to severely active Crohn’s disease.

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

The agency has published guidance on good practices for securing the supply of medicines.

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

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

FDA has spurred investment to create and develop 600 therapies.

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

A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.

The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.