Quality Systems

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

Articles

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.

EU’s New Telematics Strategy for the Regulation of Medicines

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

Serialization Shake Out

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

Collaborating on GMP Inspections

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

Regulation of Medical Devices and Companion Diagnostics

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

Unravelling the Complexity of EU’s ATMP Regulatory Framework

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

EU’s New Post-Authorization Variations Framework Comes Under Scrutiny

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.

A New World for Pharma Regulations?

ICH Prepares for Major Reform

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

The Role of Regulatory Advice in Drug Development

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

European Regulatory Watch