Regulatory/GMP Compliance, Europe

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?

A pilot project, beginning in 2017, will support the development of biosimilars.

The agency announces that 81 medicines overall were recommended in 2016.

Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA’s inspection capabilities in Europe and beyond.

Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

FDA and EMA set up new working group on the development of treatments for rare diseases.

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

The agency has recommended marketing authorization for Ibrance in the European Union.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

The three-year report emphasizes the roll of collaboration in drug safety.

The report addressed how the agency might support medicine development for patients’ unmet medical needs.

The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.

The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

The agency says, for now, it’s business as usual.The European Medicines Agency (EMA) says the future location of the agency will be determined by common agreement between representatives of the Member States, according to a July 6, 2016 statement. Until then, EMA says it will be conducting business as usual, and the outcome of the June 23 referendum will not affect the agency’s operations.

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

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.

The agency published a report on fostering the development of advanced therapy medicinal products.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.