Regulatory/GMP Compliance, Europe

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

The agency published an action plan to nurture innovation and drug development by SMEs.

The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.

The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.

The agency’s Committee for Medicinal Products for Human Use recommended AstraZeneca’s brodalumab for the treatment of moderate-to-severe plaque psoriasis.

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.

The agency released its report on pilot project to involve patients in the assessment of medicines.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

On April 28, 2017, the European Medicines Agency announced that it met with members of the heads of the National Competent Authorities (NCAs) of the member states of the European Union to discuss the United Kingdom’s exit from the EU (Brexit) and how the agency and the member states will handle the evaluation and monitoring of drugs going forward.

April 24–30, 2017 is European Immunization Week in Europe, and in a statement on the European Medicines Agency (EMA) website dated April 25, 2017, Executive Director Guido Rasi stressed the importance of vaccinations in preventing and controlling disease. Rasi acknowledged that fear created from incorrect information presented by unreliable sources has created a lack of trust in vaccines. But he highlighted that Europe monitors and records information on the safety of medicines, including vaccines.

On April 24, 2017, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and a group of executives from several big pharma companies composed an open letter to the European Medicines Agency (EMA) regarding its relocation.

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.

The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.

A new study in NEJM compares the regulatory review processes of FDA and EMA.

EMA has developed a framework and action plan to foster relationships with the academic community.

The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs

The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

The agency published an overview of marketing authorizations made in 2016.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

How involved should HTA bodies be in assessing cost effectiveness and reimbursements?