Quality Systems

A Robust Quality Culture Benefits All

Establishing a quality culture ensures a safe and effective product, and saves costs.

Put a Cap on CAPAs

Data may be used to improve (or remove) a corrective action/preventive action.

Quality Management Through Process Performance

Testing various tablet-splitting devices showed how well they performed.

MHRA Updates Guidance on Handling of Approved or Pending DCP and MRP

June 27, 2022

The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.

FDA Leaders Seek to Build Public Trust in Science and Gain Support for Regulation

June 22, 2022

FDA is at a pivotal moment because of important gains in medical treatment based on science.

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

June 21, 2022

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

International Collaboration on Pharmaceutical Regulations

June 21, 2022

Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.

FDA User Fee Legislation Advances in Senate

June 17, 2022

Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.

MHRA to Play Greater Role in International Medicines Regulation

June 17, 2022

MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.

Icosapent Ethyl Gains Nod from NICE

June 17, 2022

NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.

FDA Publishes Draft Quality Risk Management Guidance

June 16, 2022

The draft ICH Q9(R1) document details the importance of quality risk management principles.

FDA Publishes Guidance on Regenerative Medicine Therapies

June 16, 2022

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

EMA Publishes 2021 Annual Report

June 10, 2022

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.