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?

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

Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.

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

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.

The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

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

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.

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

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.

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 pharmaceutical industry now braces itself for the consequences and complexities that could follow in the wake of the United Kingdom’s decision to leave the European Union.

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 has recommended granting marketing authorization in the EU for Truvada.

The agency reviews hemophilia A, skin, and diabetes treatments, among others.

The agency completes its risk assessment of the blood cancer treatments.

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

ICH detailed the highlights of the council’s June 2016 meeting.

The agency is following up on a February 2016 inspection of the facility that found GMP violations.

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

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.