Regulatory Oversight and Compliance

EMA and ECHA sign agreement to share information and work together on risk assessments.

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

FDA clarifies stability data recommendations for abbreviated new drug applications.

Life-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

How badly is Brazil's pharmaceutical market suffering from the global instability of emerging markets?

New formulations and expanded vaccine production are encouraged.

Biopharma companies should not overlook India's growing market.

The European Medicines Agency's Annual Report highlights drug approvals, projects, and initiatives for 2013.

The cleaning validation lifecycle includes assessment, development, validation, and monitoring.

EMA sends its results on Roche investigation of pharmacovigilance non-compliance to the European Commission.

How badly is Brazil's pharmaceutical market suffering from the global instability of emerging markets?

New identifiers and tracking requirements aim to block illegitimate products.

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

GSK recalls alli weight loss products in the US and Puerto Rico.

Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

Agencies extend successful pilot program to further harmonization of QbD topics.

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

Manufacturers are taking measures to comply with new package safety rules.

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

Accelerated testing and production create challenges in documenting product quality.

Using best practices for manual or automatic inspection can improve the inspection process.

The root cause of drug shortages is mismanagement of variation.