Quality Systems

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

Articles

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

A Question of Quality

The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.

EMA Faces Brexit Challenges

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.

The Complexity of IDMP

Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.

EU–US Mutual Recognition Agreement on GMP Inspections

Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.

EU Strives for Regulatory Efficiency

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.

Moving Forward with Adaptive Licensing

How involved should HTA bodies be in assessing cost effectiveness and reimbursements?

The Evolving Role of HTA Bodies Sparks Scrutiny

Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.

Bridging Gaps in the Global Regulatory Framework

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.

Tackling Breaches in Data Integrity

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

European Regulatory Watch