Regulatory/GMP Compliance, Europe

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.

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?

EMA publishes reflection paper on issues regarding the parenteral administration of coated nanomedicines.

EMA restructures organization.

EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

Europe prepares for inclusion of Croatia in EMA activities.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

EMA clarifies biosimilars guidelines.