European Regulatory Watch

The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.

Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.

The complexity of new packaging regulations laid out in the Falsified Medicines Directive could threaten the existence of smaller pharma and packaging companies.

EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.

The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.

The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

Drug developers understand the importance of early communication with regulators, but is EMA providing enough flexibility and support to companies?

Proposals to make the decentralized procedure more efficient were discussed at the January 2015 EGA conference.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

Resolving the problem will require more communication between the industry and regulatory bodies.

The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.

Iclusig?s original indication will remain unchanged after a thorough examination of its safety information by EMA.

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

The European Union has developed a system for evaluating, approving and monitoring the safety of medicines that has also encouraged innovation.

Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.

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.

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

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?