EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications

The FDA and the European Medicines Agency (EMA) have jointly published "EMA–FDA joint Q&As on Quality and GMP aspects," aiming to support quality enhancement for FDA's Breakthrough Therapy (BT) and EMA's Priority Medicines (PRIME) programs.

Following a 2018 workshop, regulators and industry stakeholders discussed quality challenges and approaches to streamline pharmaceutical quality data packages while emphasizing patient access and regulatory standards.

While applicable to chemical and biological medicinal products under EMA's purview, the Q&As are limited to CDER-regulated products for the FDA, excluding CBER-regulated products like ATMPs.

The document covers the Control Strategy, Process Validation, Alternatives for re-test period or shelf-life determination, and GMP Post-Approval Change Management Protocol (PACMP).

Post-approval, proposed control strategies may require adjustments based on additional information, necessitating the implementation of a PACMP to manage changes effectively.

GMP considerations entail compliance with the investigational medicinal product (IMP) manufacturing process and facility, along with a thorough transition plan to full commercial manufacturing, ensuring comparability and post-marketing commitments.

Refer to the "EMA–FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications" document for further details.