Regulatory Oversight

The company is voluntarily recalling the product for potential super potent bottles due to overfilling.

Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

IREM can be used for effectively assessing and mitigating risks and improving the overall sterility assurance level in all types of aseptic processing lines.

Regulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.

The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.

FDA has published final guidance documents regarding validation and development of analytical procedures.

This article explores the emergence of subjectivity in ICH Q9 (R1).

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

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

Steffen Thirstrup, chief medical officer at the European Medicines Agency, provides insight on regulatory challenges in Europe.

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

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

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).

Harmonization of global regulations fosters innovation and ensures quality medicines.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Revolutionary therapies restructure pharmaceutical manufacturing.

European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.