Regulatory/GMP Compliance, Europe

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

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

European Medicines Agency clarifies advanced-therapy medicinal products classification.

EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.

Despite GMP deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.

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

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

EMA and ECHA sign agreement to share information and work together on risk assessments.

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 drug approvals, projects, and initiatives for 2013.

EMA sends its results on Roche investigation of pharmacovigilance non-compliance to the European Commission.

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.

Manufacturers are taking measures to comply with new package safety rules.

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.

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

Includes a new approach on developing antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options.

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

EMA revises HIV treatment guideline.

EMA releases details of restructuring.

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

Agencies collaborate to ensure consistent product quality.

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

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

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

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

EMA streamlines orphan drug application procedure.