Regulatory Oversight and Compliance

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.

Discovery of split and broken tablets led to drug recalls.

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.

USP's revised Chapters 41 and 1251, which became official in December 2013, have new requirements for weighing, including balance calibration and testing.