Bioequivalence and Bioavailability Forum

Dear All,

I have shifted to China to set up a Bio-Analytical unit for a Chinese Bio-equivalence organization. We are in the initial stages of building up a laboratory in China. I have some query regarding preparation of SOP and related forms to be used in regulated bio-analysis. We are planning to target studies for USFDA, EMEA, ANVISA, UK-MHRA, MCC and also CFDA.

Is it required to prepare every SOP bi-lingual i.e. in Chinese as well as English language? Can we prepare the SOP's in English language only. We are planning to recruit staff with English proficiency only from China, India or other countries. So will it be mandatory by CFDA that we prepare these SOP's in chinese also?

Also, regarding protocols and reports, can we submit English version of these to CFDA? or do they require the documents in Chinese language only?

Thanking you in advance.

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Edit: Category changed; see also this post #1. [Helmut]