Interview with Milestone
Ahead of next month's Extractables & Leachables China 2021, we recently spoke to the expert speaker, Cheney Lin, VP from Milestone. Our exclusive interview covers a sneak peek of his presentation at the ‘Discussion on the standardized testing methods of compatibility studies', as well as his insights on the similarities and differences of domestic and global declarations. Take a look below now to find out what was said...
Q. What are the biggest challenges facing the E&L sector in China?
At present, regulatory authorities and associations in various countries have released several guidelines for E&L study, such as Center for Drug Evaluation, NMPA, US FDA, EMEA, USP, BPOG, BPSA, PQRI. They proposed contents such as risk assessment of compatibility studies and demonstration methods of extractables detection. It shows that contents of extraction conditions, sample treatment, solvent selection, range of temperature, etc. account for the major part of the relevant documents. But there is still less description of the most important standardization of analytical methods related to the reliability of data results. It’s necessary to actively promote the standardization in China.
Q. What are the similarities and differences of domestic and global declarations in E&L realm?
Domestic declarations focus on the recommended testing process of known extractables, and this part has been guided by several relevant guidelines. For example, determination of the known extractables of medical devices has been issued by the National Medical Products Administration in 2019.
It’s easy to implement with available standard substance, clear limitation of regulation, definite test methods and substance to be tested. However, the global declarations focus on the scanning for unknown extractables. For the methodology study of this part, currently there is no clear standards with regulatory guidelines in China.
Q. Your presentation at E&L China this year is titled “Discussion on the standardized testing methods of compatibility studies”. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
My topic will cover “Discussion on the standardized testing methods of compatibility studies”. We hope to promote the standardization of the qualitative and quantitative analysis, and risk assessment of unknown substance in China by initiating a discussion and drawing lessons from some real examples of the current declarations of EU and US.
Q. What are you most looking forward to at the conference of E&L China?
Since compatibility study is a complex research process and system, I expect during this conference the China E&L society work out more standardization efforts, more complete toxicological evaluation system, and more scientific chemical analysis procedures.