Regulatory Oversight and Compliance

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

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

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.

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.

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.

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.

EMA releases an update on its flu vaccine guidance.

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

High technology assessments are having an impact on biosimilars development in Europe.

EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.

FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location

FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

FDA and EMA launch initiative to share bioequivalence inspection information.

Agency issues precautionary recall due to manufacturing fault.

Agency issues precautionary recall due to manufacturing fault.

OGD is under pressure to improve review operations.

Teva Pharmaceutical Industries releases a financial outlook for 2014 based on two possible scenarios concerning its multiple-sclerosis drug Copaxone (glatiramer acetate).

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.