EMA Releases Guidelines on Advanced Therapies
The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.
On Nov. 24, 2017, the European Medicines Agency (EMA) published good manufacturing practice (GMP) guidelines specific to advanced therapy medicinal products (ATMPs). The guidelines adapt European Union GMPs to ATMPs and address the complex manufacturing issues that are associated with these products. The guidelines promote a risk-based approach to manufacturing and testing ATMPs within high quality standards.
The guidelines are part of a joint action plan launched by the Directorate General for Health and Food Safety (DG SANTE) and EMA in October 2017 to foster the development of ATMPs. They were developed with input from EMA’s Committee for Advanced Therapies and GMP/Good Distribution Practice Inspectors Working Group.
ATMPs are treatments based on gene or cells and can offer new options for patients with severe, untreatable, or chronic conditions.
Source: EMA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
