Although China is yet to adopt International Conference on Harmonisation (ICH) Q8, Q9 or Q10, the State Food and Drug Administration (SFDA) embraces the principles of QbD (quality-by-design) and will accept applications. However, fears of delays mean few QbD applications are submitted.
“Industry is concerned about review and approval timelines”, Chi-wan Chen, executive director, global CMC (chemistry, manufacturing and control) at Pfizer, said at AAPS 2011. Until the SFDA acts to reduce these fears QbD applications will be rare.
The first thing the SFDA can do is hire more CMC reviewers, Chen said. Currently the SFDA has 25 CMC reviewers and little experience of handling QbD applications. By expanding the team and adding more opportunities for discussion before submission the SFDA could encourage QbD submissions.
Chen would also welcome steps to move regulations in China closer to those in ICH nations. China has already moved in this direction by strengthening good manufacturing practices (GMPs).
Willingness to harmonise
The SFDA is willing to adopt international standards, Mark Paxton, former associate vice president, international regulatory affairs at PhRMA (Pharmaceutical Research and Manufacturers of America), said.
When working at PhRMA Paxton helped identify barriers to regulatory submissions compared to procedures in the US. China had 25 barriers, more than any other country, but the SFDA was keen to address the bottlenecks.
“As a consequence of our guidance the SFDA wanted to enter into a memorandum of understanding (MOU) with PhRMA”, Paxton said. The MOU never happened but the intent shows the SFDA is open to harmonisation.
Industry can support the process by working with the SFDA on the adaptation of US and European technical guidelines for use in China. The SFDA is accelerating this process, Chen said, and over the past three years has interacted much more with industry groups.