Quality Systems

Sean Milmo is a freelance writer based in Essex, UK.

Articles

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

Quality by Design&#151;Bridging the Gap between Concept and Implementation

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

European Union Packaging Safety Features Come into Effect

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

EMA Collaborates with HTA Assessment Networks

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.

Early Communication with Regulators is Essential for SMEs

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).

Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

European Union Introduces GMPs for Excipients

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?

EU Raises API Standards: A Curse in Disguise?

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

Seeking Harmonization in Nanomedicines Regulatory Framework

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

EU Battles Medicine Shortages

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

European Regulatory Watch