Global excipient manufacturers, working through the International Pharmaceutical Excipients Council (IPEC) Federation and IPEC-China, continue to encourage the Chinese Pharmacopeia (ChP) to propose science-based changes that would move the ChP toward better alignment with other global pharmacopeias.
Also being closely monitored by the council are the frequent changes to the requirements for drug application filings and excipient registration – which may sometimes come with short notice and implementation timelines.
IPEC has been very active in commenting on draft documents from Chinese regulators through a small and agile working group – necessitated by the typically limited comment periods and the need to translate the initial documents, distribute them globally to the IPEC community for feedback, collate responses, and then translate the documents back into Chinese for submission.
The excipient and pharmaceutical community was updated on the current Chinese regulatory environment by IPEC’s Dave Schoneker at the May 2019 IPEC Excipient World Conference, held in National Harbor, Maryland. Currently serving as IPEC-Americas Vice Chair of Science and Regulatory Policy, he has previously served as chair of IPEC-Americas, and played an important role in the development of IPEC-China and IPEC-India.
Schoneker reviewed some of the territory he had addressed at the 2017 and 2018 ExcipientFest conferences [see IPQ July 1, 2017 and August 31, 2018] – adding the perspective of the developments and the discussions between IPEC and the Chinese regulators that have taken place over the past year.
His recent presentation encompassed: ● China’s regulations from 2001 to the present including the registration, bundling review, and joint review systems ● recent developments, including regulatory reorganization and guidances, and ● changes to the Chinese pharmacopeia and industry’s role in addressing non-harmonized ChP monograph issues.