Regulatory Oversight

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

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.

Harmonization of global regulations fosters innovation and ensures quality medicines.

The European bio/pharma industry’s high regulatory standards and GMP requirements are set to position the region as a frontrunner for pharmaceutical‑grade manufacturing of cannabis-based medicines.

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

The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

FDA sent a variety of warning letters to drug manufacturers at the end of 2022 highlighting myriad CGMP and quality control violations.

In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.

A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel.

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.

Unique dosage forms, personalized medicine, and flexible manufacturing are possible with 3DP.

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

Health crises, political tension, and budget concerns were major challenges.

The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.

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.

Industry experts discuss best practices for certificates of analysis.

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

A blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.

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

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

A new survey has demonstrated that remote audits, brought to the fore thanks to COVID-19, are not necessarily a preferred option for clients.

A Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

Innovation is driven through a strong digital backbone.

An integrated approach to the data lifecycle is key to successful digital transformation.