Editing Bioequivalence (section)

=== China ===
[[File:仿制药一致性评价LOGO.svg|thumb|right| Passing drugs may display this blue checkmark sign with the text {{lang|zh|仿制药一致性评价}} (Generic Drug Consistency Evaluation).<ref>{{cite web |trans-title=Announcement from the General Administration on Matters Related to the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (No. 100 of 2017)|script-title=zh:总局关于仿制药质量和疗效一致性评价工作有关事项的公告（2017年第100号） |url=https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20170825205601306.html?type=pc&m= |website=nmpa.gov.cn |access-date=18 September 2024}}</ref>]]
There were no requirements for bioequivalence in generic medications in China until the 2016 ''Opinion on Conducting Consistent Evaluation of the Quality and Efficacy of Generic Drugs'' ({{lang|zh|关于开展仿制药质量和疗效一致性评价的意见}}), which established basic rules for future bioequivalence work. Since July 2020, all newly-approved generics must pass bioequivalence checks; previous drugs may apply to be checked. Since 2019, National Centralized Volume-Based Procurement uses "passes generic-consistency evalulation" as one of the bidding criteria.<ref name="Su">{{cite journal |author1=苏华 |author2=郭瑞臣 |script-title=zh:仿制药一致性评价的背景、实施及结局|trans-title=The background, implementation and outcome of the consistency evaluation of generic drugs |journal=中国医院药学杂志 [Chinese Journal of Hospital Pharmacy] |date=2022 |volume=42 |issue=14 |doi=10.13286/j.1001-5213.2022.14.21 |url=http://journal18.magtechjournal.com/Jwk_zgyyyx/CN/10.13286/j.1001-5213.2022.14.21}}</ref>

The Chinese definition of "bioequivalence" entails having the test drug's geometric mean C<sub>max</sub>, AUC<sub>(0–t)</sub>, and AUC<sub>(0–∞)</sub> fall into 80%&ndash;125% of the reference drug in both fasting and fed states. The reference drug should be preferably the original brand-name drug, then (if not available) an internationally-recognized generic approved by a developed country, then (if still not available) an internationally-recognized generic approved domestically &ndash; this is to avoid deviation from the original drug by serial use of generics as reference. If pharmacokinetic values such as C<sub>max</sub> do not apply to the type of drug (e.g. if the drug is not absorbed orally), comparisons can be made using other means such as [[dose-response curve]]s.<ref name=Su/>

According to Wei et al. (2022), the Consistency Evaluation Policy increased R&D spending for Chinese pharmaceutical companies, especially among private and high-yielding ones.<ref>{{cite journal |last1=Wei |first1=Y |last2=Zhu |first2=J |last3=Qiao |first3=J |last4=Zhang |first4=D |last5=Chen |first5=Y |last6=Suchecki |first6=S |title=The Impact of the Consistency Evaluation Policy of Generic Drugs on R&D Investment Intensity of Pharmaceutical Companies-An Empirical Study Based on the Difference-in-Differences Model. |journal=Frontiers in Public Health |date=2022 |volume=10 |pages=902025 |doi=10.3389/fpubh.2022.902025 |doi-access=free |pmid=35757628 |pmc=9218526}}</ref> Liu et al. (2023) argues that the Policy increased the innovation quality of the Chinese pharmaceutical industry.<ref>{{cite journal |last1=Liu |first1=Q |last2=Huang |first2=Z |last3=Mao |first3=Z |title=Has the consistency evaluation policy of generic drugs promoted the innovation quality of Chinese pharmaceutical manufacturing industry? An empirical study based on the difference-in-differences model. |journal=Frontiers in Public Health |date=2023 |volume=11 |pages=1265756 |doi=10.3389/fpubh.2023.1265756 |doi-access=free |pmid=38106910 |pmc=10722264}}</ref>