Regulatory/GMP Compliance, Europe

The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards

The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process.

The agency creates initiative to stimulate pediatric drug development.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

The agency has recommended granting marketing authorization for Opdivo.

The European Medicines Agency releases findings from marketing authorization application analysis.

This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

The agency creates an electronic central repository to facilitate drug safety assessment reports.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting

Revised EMA policy reflects more balanced approach and experts are to submit updated declarations of interests by end of January 2015.

The European Medicines Agency responds to the European Ombudsman?s letter regarding redacted documents.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

The European Medicines Agency releases highlights from its Pharmacovigilance Risk Assessment Committee safety review meeting in October.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

The European system for assessing drugs will be used as a model internationally.