The GRRO China Subgroup proactively conducts outreach and knowledge sharing with various stakeholders in China, including the National Medical Products Administration (NMPA) and its agencies such as the National Institutes for Food and Drug Control (NIFDC), the Center for Drug Evaluation (CDE), and the Chinese Pharmacopoeia (ChP). The group also interacts with China based industry groups such as the Inhalation Drug Delivery Association and the Chinese National Pharmaceutical Packaging Association.
Importantly, GRRO China shares information and experiences with implementing current and emerging guidelines, regulations and standards from the Chinese health authorities.
Through roundtable discussions, regulatory monitoring, workshops and conferences, the group brings impactful regulatory experiences and scientific information to the Consortium membership, and other stakeholders. Recent activities include leading submission of IPAC-RS comments to:
The CDE draft guideline on bioequivalence for inhalation products
The ChP inhalation and nasal-related chapters: 0111 Inhalation Preparations; 0112 Sprays; 0113 Aerosols
The CNPPA draft guideline on extractables studies for inhalation products