EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications

The European Medicines AgencyThe European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications.

Quality-by-design is a science- and risk-based approach to pharmaceutical development and manufacturing that was introduced a few years ago in international guidelines intended for the pharmaceutical industry. QbD involves the use of statistical, analytical and risk-assessment methods to design and develop pharmaceutical compounds and manufacturing processes to ensure the quality of the manufactured product.

In March 2011, the EMA and the US FDA launched a three-year pilot programme for the parallel assessment of certain quality or chemistry, manufacturing and control (CMC) sections of applications that are relevant to QbD.

The objective of this parallel assessment is to share knowledge, facilitate a consistent implementation of the international guidelines on the implementation of the QbD concept (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines Q8, Q9, Q10 and Q11) and promote the availability of pharmaceutical products of consistent quality throughout the European Union and the US.

The programme is open to selected procedures, including applications for initial marketing authorisations, type-II variations and scientific advice. Participation in the pilot is voluntary. Interested applicants and sponsors should notify both agencies three months prior to submission of an application.

Both agencies found the first parallel assessment extremely useful and reached agreement on a wide range of QbD aspects, as reflected in the question-and-answer document. Experts from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) participated as observers in this first parallel assessment, with the agreement of the applicant.

The EMA and the US FDA will publish further conclusions on other QbD-related topics as the pilot programme continues and more parallel assessments are conducted.

Most Popular Now

Delivering insulin in a pill

Given the choice of taking a pill or injecting oneself with a needle, most of us would opt to regulate a chronic health condition by swallowing a pill. But for millions o...

Can aspirin treat Alzheimer's?

A regimen of low-dose aspirin potentially may reduce plaques in the brain, which will reduce Alzheimer's disease pathology and protect memory, according to neurological r...

Probiotics can protect the skeletons of older wome…

For the first time in the world, researchers at the University of Gothenburg, Sweden, have demonstrated that probiotics, dietary supplements with health-promoting bacteri...

Alzheimer's breakthrough: Brain metals that may dr…

Alzheimer's disease could be better treated, thanks to a breakthrough discovery of the properties of the metals in the brain involved in the progression of the neurodegen...

FDA approves first drug comprised of an active ing…

The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms o...

Researchers develop a new method for turning skin …

Our bodies consist of many different kinds of cells, each with their own role. The Japanese scientist Shinya Yamanaka had made earlier the discovery, earning the Nobel Pr...

Some existing anti-cancer drugs may act in part by…

Bolstering the notion that RNA should be considered an important drug-discovery target, scientists at Scripps Research have found that several existing, FDA-approved anti...

FDA takes steps to foster greater efficiency in bi…

Today, the agency withdrew the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity," issued in September 2017. The draft guidance, if finalized as w...

Poliovirus therapy for recurrent glioblastoma has …

A genetically modified poliovirus therapy developed at Duke Cancer Institute shows significantly improved long-term survival for patients with recurrent glioblastoma, wit...

Novartis Clear about Psoriasis survey data highlig…

Novartis announced today the publication of global Clear about Psoriasis survey data in the Journal of the European Academy of Dermatology and Venereology[1]. The publica...

Human clinical trial reveals verapamil as an effec…

Researchers at the University of Alabama at Birmingham Comprehensive Diabetes Center have discovered a safe and effective novel therapy to reduce insulin requirements and...

How targeting metabolism can defeat cancer stem ce…

Researchers are the University of Michigan Rogel Cancer are unraveling a crucial thread that explains why cancer so often becomes resistant to treatment. In a breakthroug...