Regulatory/GMP Compliance, Europe

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

EMA publishes revised guideline on the acceptability of names for drugs.

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

EMA opens registration for it's sixth annual workshop on pediatric drug research and development.

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.

The European Medicines Agency's Annual Report highlights the agency's drug approvals, projects, and initiatives for 2013.

EMA notifies EU healthcare professionals of the falsified cancer drug Herceptin.

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

Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.

Agencies extend successful pilot program to further harmonization of QbD topics.

FDA and EMA set up regular meetings to harmonize drug safety actions.

EMA releases an update on its flu vaccine guidance.

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

High technology assessments are having an impact on biosimilars development in Europe.

EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.

In 2013, the EMA's Committee for Medicinal Products for Human Use recommended 81 medicines for human use for marketing authorization, compared with 57 in 2012.

FDA and EMA launch initiative to share bioequivalence inspection information.

EMA revises its polices on fee reductions for orphan drugs for 2014.

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).

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

EMA and FDA publish joint QbD guidance on design space verification.

EMA revises HIV treatment guideline.

EMA releases details of restructuring.

The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.