Differences in pharmaceutical quality requirements across APEC economies can lead to duplicative testing, inspection, and review activities that delay access to medicines and strain limited regulatory resources. The Pharmaceutical Quality Priority Work Area (PWA) of the Regulatory Harmonization Steering Committee (RHSC) promotes science- and risk-based approaches to the quality of pharmaceutical drug substances and drug products, both chemical and biological. It covers their full lifecycle, from development and manufacturing through review, inspection, and post-approval changes. The PWA draws on internationally recognized standards, in particular the quality guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The PWA aims to:
- build a shared understanding of pharmaceutical quality, and of current practices and gaps in regulatory oversight, across APEC economies;
- build the capacity of regulators and industry to apply science- and risk-based approaches and to implement ICH quality guidelines;
- measure progress toward convergence using specific indicators; and
- over the longer term, facilitate regulatory reliance and recognition among APEC regulators based on shared scientific principles.
CHAMPION
- U.S. Food and Drug Administration (FDA), United States
SUB-CHAMPION
- Pharmaceutical Research and Manufacturers of America (PhRMA)
The PWA Champion’s contacts can be found here.
CENTERS OF EXCELLENCE
The RHSC has not yet designated a Center of Excellence for this PWA.
ROADMAP
The Pharmaceutical Quality PWA roadmap can be found here (PDF).