Regulatory Watch

Regulators and manufacturers address economic and ethical issues for scarce medicines.

The pharmaceutical industry now braces itself for the consequences and complexities that could follow in the wake of the United Kingdom’s decision to leave the European Union.

Agency guidance and industry standards aim to reduce lapses and improve quality operations.

The impact of pharmaceutical manufacturing on the environment has triggered demands for tighter environmental controls in EU and national legislations.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.

The campaign against opioid abuse opens door to more innovative therapies.

Global outbreaks energize vaccine R&D and drive production modernization.

Policy makers debate strategies for promoting access to less costly medicines.

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.

The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.

The bio/pharmaceutical industry will face increased scrutiny of product quality and cost drivers.

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.

New program emphasizes quality, risk, and global collaboration.

The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.

Manufacturers challenge details in new policies designed to promote access to important therapies.

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.

The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.

FDA and industry support global framework and collaborations to secure the supply chain.

Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.

Regulators and industry seek to streamline and harmonize oversight of postapproval changes.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

More reliable operations would accelerate product development and prevent drug shortages.

Scientists and industry experts seek effective preventive therapies to combat global disease.

Proposals to make the decentralized procedure more efficient were discussed at the January 2015 EGA conference.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.