Quality Systems

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

Articles

The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.

ICH Q12 Guidelines Spark Controversies

The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks. 

Tackling Medicine Shortages in Europe

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.

Barriers to ATMP Drug Development

The repercussions of EMA’s relocation and Brexit will continue to be the dominant regulatory issue throughout 2018.

Pharma Braces Itself for Post-Brexit Regulatory Changes

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

Disputes Over Manufacturing Waiver and Other SPC Exemptions

The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.


Europe Leads the Way in Continuous Manufacturing

The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.


Pharmaceutical Environmental Pollution and Antimicrobial Resistance

EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.

Regulation of Companion Diagnostics

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.


EMA Increases Support for SMEs

The agency is asking public consultation on the concept paper.

European Regulatory Watch