Quality Systems

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

Articles

The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.

Europe Pushes for Global Easing of Generics Approvals

Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.


Spotlight on Assessing the Environmental Impact of Medicines

This coming year could see a combination of regulatory uncertainty and inactivity for the pharma industry, mainly as a result of Brexit.

A Year of Possible Regulatory Upheaval and Paralysis

EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.

Relocating EMA: A Far from Ideal Situation

Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.

Guidelines on Integral Drug-Device Combinations

A European task force outlines its upcoming efforts to combat drug shortages.

Curbing Drug Shortages in Europe

The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars. 

Disputes Over SPC Waivers

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

Pharmaceuticals in the Environment

EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.

Collaboration on GMP Inspections Has Been Successful but Challenges Exist

The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.

European Regulatory Watch