Regulatory Oversight and Compliance

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.

The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

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).

The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.

Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.

FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.

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.

MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.

Revolutionary therapies restructure pharmaceutical manufacturing.

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

A thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.

UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.

Analytical methods and tools play a pivotal role in cleaning validation.