The China Subgroup proactively develops collaborative relationships with various stakeholders in China, including Chinese FDA and provincial FDAs, pharmacopeia, other standard-setting bodies, pharmaceutical industry, suppliers and other trade groups. The Subgroup stays abreast of, and influences as appropriate, regulatory developments for OINDPs in China.
The China Subgroup has been actively reaching out to Chinese FDA (CFDA) with the goal to help shape the development of scientifically-based guidances and regulations for OINDP in China. Through its effort, IPAC-RS is now recognized by the CFDA as a leading resource for scientific knowledge and expertise in OINDP industry.
The China Subgroup is also liaising with other industry or trade associations, especially those China-located associations, to monitor and influence the development of best practices, standards and regulations for OINDPs. These associations include R&D-based Pharmaceutical Association Committee in China (RDPAC) and Inhalation Drug Delivery Association (IDDA) in China.
Through material translation (e.g. translation of IPAC-RS webinars on Materials Quality, L&E Handbook), conference presentations and webinar/workshop sponsorship, the Subgroup is helping, and will continue to help, educate stakeholders in China on OINDPs.
The GRRO China and Materials Working Groups are leading the consolidation and submission of IPAC-RS comments on the CNPPA guideline for elastomeric components for drug products (including inhalation products).
IPAC-RS representatives were invited to and will participate in a symposium about the fundamentals of aerosols drugs organized by the National Institute for Food and Drug Control (NIFDC), a component of the Chinese FDA, and will chair and present at a session on materials quality and extractables/leachables at Inhalation Asia.
Dr. Ying Li (Merck), Chair of the GRRO China Subgroup, was invited to attend and present on IPAC-RS at the Chinese Inhalation Drug Delivery Association (IDDA) annual conference in Nanjing, China in October 2014. Over 200 scientists from regulatory, industry and academia attended the conference.
IPAC-RS representatives participated in a training workshop at the Taiwan Center for Drug Evaluation in September 2014. Their presentations were successful and very well received. They also participated in the Chinese National Pharmaceutical Packaging Association’s (CNPPA) 2014 Forum for Infusion Packaging Development on 18-19 September in Qingdao, China.
IPAC-RS representatives met with representatives from the China National Pharmaceutical Packaging Association (CNPPA) to discuss the CNPPA translating the L&E Handbook into Chinese. During this meeting IPAC-RS participants presented general education information on L&E for inhalation products to a diverse audience of industry and regulatory attendees. IPAC-RS also met with the National Institutes for Food and Drug Control (NIFDC). NIFDC is keen to leverage IPAC-RS’ expertise and is interested in collaboration to include other types of drug product studies.