Regulatory/GMP Compliance, Europe

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

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.