Manufacturers are taking measures to comply with new package safety rules.
High technology assessments are having an impact on biosimilars development in Europe.
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.
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).
Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
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.
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.