Regulatory Watch

Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.

Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.

New gene therapies and combination products require innovative regulatory approaches.

FDA seeks to focus on problematic facilities and inform firms quickly about site problems.

Industry and FDA face new fee structures and new challenges in implementing fee initiatives.

FDA works with industry on strategies for assuring high-quality regenerative medicines.

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.

Approval of breakthrough therapies requires expedited quality assessment.

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.

Industry fears limited benefits as FDA readies voluntary data tracking program.

Policies limiting imports and immigration generate uncertainty for US and foreign firms

Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.

User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.

FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.

How involved should HTA bodies be in assessing cost effectiveness and reimbursements?

Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.

Republican control of Washington promises overhaul of healthcare and medical product regulation.

Reliable, high-quality products require innovative analytics and production.

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.

Efforts to accelerate drug development will alter fee structure and require ready production sites.

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.