EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

EMAEMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines. This is one of the findings of a joint EMA/FDA analysis comparing decisions on 107 new medicine applications at the two agencies between 2014 and 2016. The study also looked at applications for which the agencies had differing outcomes in terms of type of approval and indication. The most common reason for diverging decisions at the two agencies were differences in conclusions about efficacy. Differences in clinical data submitted in support of an application were the second most common root of divergent FDA and EMA decisions.

"The high rate of convergence in the authorisation of new medicines at EMA and the FDA is the result of expanded investment in dialogue and cooperation since 2003 and has fostered alignment between the EU and the US with respect to decisions on marketing authorisations, while both agencies evaluate applications independently of each other," said Zaide Frias, head of EMA's human medicines evaluation division. "Our cooperation clearly supports both agencies in achieving a common goal of maximising patient access to safe, effective and high quality medicines in both regions," she added.

This is the first analysis by EMA and the FDA that compares the agencies' decisions related to marketing authorisations.

Some differences were observed in the clinical data due to the difference in timing of submissions (more applications were submitted to the FDA before they were submitted to EMA). Compared to the FDA, EMA often reviewed applications including additional clinical trials or, particularly for oncology medicines, more mature data from the same clinical trial. In those instances, EMA was more likely than the FDA to grant standard approval, a broader indication, or use of a medicine as first-line therapy.

Over the past decade, EMA and the FDA have established joint working groups and several forums for information sharing and collaboration around many aspects of medicine development and regulation, including 'clusters' on special topics and therapeutic areas, as well as parallel scientific advice and protocol assistance. These groups bring together experts for example on plans for manufacturing or clinical site inspections, development of medicines for children, oncology products, biostatistics, rare diseases and vaccines. While these groups are not forums for shared decision-making, the strong alignment in decisions on marketing authorisations suggests that they may be contributing to alignment on regulatory science.

Most of the information used for the study was sourced from EMA's publicly available European Public Assessment Reports (EPARs) and FDA reviews, which contain the agencies' rationale for their decisions on applications.

The article, entitled "A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why", is available through open access in Clinical Pharmacology and Therapeutics.

Most Popular Now

Theravance Biopharma and Pfizer Inc. enter global …

Theravance Biopharma Ireland Limited, a subsidiary of Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Pfizer Inc. (NYSE: PFE) ("Pfizer") today anno...

Amgen and Allergan submit Biologics License Applic…

Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) fo...

Researchers identify immune-suppressing target in …

Researchers at The University of Texas MD Anderson Cancer Center have identified a tenacious subset of immune macrophages that thwart treatment of glioblastoma with anti-...

Lynparza recommended by FDA advisory committee for…

AstraZeneca and MSD Inc., Kenilworth, NJ, US (MSD: known as Merck & Co., Inc. inside the US and Canada) announced that the US Food and Drug Administration (FDA) Oncologic...

Old drug offers new hope for children with devasta…

A drug that once helped obese adults lose weight, but was withdrawn from the market due to heart risks, may be safe and effective for children with a life-threatening sei...

Intermittent fasting: live 'fast,' live longer?

For many people, the New Year is a time to adopt new habits as a renewed commitment to personal health. Newly enthusiastic fitness buffs pack into gyms and grocery stores...

Pharmacies leave customers hanging when it comes t…

Proper disposal of leftover medication, particularly antibiotics and opioids, can help reduce antibiotic resistance, prevent children from being poisoned and stop the mis...

Researchers determine how a specific protein regul…

Immune checkpoints are surface proteins that cancer cells use to evade immune response. These surface proteins are critical for cancer cell growth and drugs targeting the...

Lynparza approved in the US as a 1st-line maintena…

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) announced that Lynparza (olaparib) has been approved in the US f...

Scientists find a new use for already known anti-c…

The world scientific community is waging a difficult and prolonged war on cancer. New research in the field of immunogenic cell death can extend the area of drugs applica...

Farxiga granted FDA Priority Review for patients w…

AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dap...

Lilly opens Phase 3 clinical trial in RET-mutant m…

Eli Lilly and Company (NYSE: LLY) announced the opening of the LIBRETTO-531 clinical trial [NCT04211337] for selpercatinib, also known as LOXO-292, for treatment-naive RE...