Regulatory/GMP Compliance, Europe

China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.

The two agencies have set up a working group on involving patients in drug development.

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

Pharma has voiced strong opposition against Britain’s departure from the EU.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.

The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.

Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.

The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.

The agency holds a workshop to strengthen collaboration with healthcare providers.

PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.

The agencies detail the results of their three-year collaboration.

The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.

The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.

The agency has revised its good pharmacovigilance practices guide on risk management systems.

UK pharmaceutical companies face £45 million in fines after entering pay-for-delay agreements for generic versions of paroxetine.

The agency prepares a plan to implement new packaging safety features.

The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.

EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.

The new executive director of the European Medicines Agency begins appointment.

The European agency presents guidelines for conducting post-authorization efficacy studies.