{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,18]],"date-time":"2026-07-18T13:04:04Z","timestamp":1784379844442,"version":"3.55.0"},"reference-count":19,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T00:00:00Z","timestamp":1783641600000},"content-version":"vor","delay-in-days":9,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>The paper systematically reviews the technical guidelines for Model\u2010Informed Drug Development (MIDD) issued by China's Center for Drug Evaluation (CDE), analyzing typical application cases of innovative drugs approved both in China and internationally to evaluate MIDD's critical role in supporting drug development and regulatory decision\u2010making. As of December 2025, CDE has released seven specific guidelines focused on quantitative pharmacology models, covering the entire drug development lifecycle, including dose exploration and optimization, pediatric extrapolation, rare disease drug development, and exposure\u2010response (E\u2010R) relationship research. MIDD have been successfully applied across multiple domains in innovative drug development, optimizing dosing regimens through E\u2010R analysis for dose selection; constructing comprehensive evidence chains via modeling and simulation for pediatric and rare disease drug development; supporting dosage rationality through population PK andPBPK models for dose adjustments in special populations; and characterizing complex in\u00a0vivo processes in advanced therapeutic products through mechanistic models. While MIDD enhances R&amp;D efficiency and reduces clinical trial burdens, the field in China currently faces three major challenges: data quality, prospective design, and validation standards. It is necessary to strengthen data collection, model validation, and full lifecycle management to promote the paradigm shift from \u201cmodel\u2010assisted\u201d to \u201cmodel\u2010driven\u201d drug development, thereby accelerating the global market entry of Chinese innovative drugs.<\/jats:p>","DOI":"10.1111\/cts.70656","type":"journal-article","created":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T03:45:48Z","timestamp":1783741548000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["<scp>MIDD<\/scp>\n                    Evidence to Support Drug Regulatory Decisions in China"],"prefix":"10.1111","volume":"19","author":[{"given":"Lili","family":"Gao","sequence":"first","affiliation":[{"name":"Center for Drug Evaluation National Medical Products Administration  China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Wang","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation National Medical Products Administration  China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruirui","family":"He","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation National Medical Products Administration  China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunmin","family":"Wei","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation National Medical Products Administration  China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,10]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"People's Daily \u201c76 Innovative Drugs Approved for Market Entry in China \u201d(2025) https:\/\/www.gov.cn\/lianbo\/202601\/content_7053894.htm."},{"key":"e_1_2_8_3_1","unstructured":"National Medical Products Administration (NMPA) Center for Drug Evaluation \u201cNotice on the Release of the Guidance on Model\u2010Informed Drug Development (2020 No. 59) \u201d(2020) https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/23b634adf79ecd4616bb91bcd66815f0."},{"key":"e_1_2_8_4_1","unstructured":"National Medical Products Administration (NMPA) Center for Drug Evaluation \u201cNotice on the Release of the Guidance on Population Pharmacokinetic Studies (2020 No. 63) \u201d(2020) https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/b3e8205a4749caa0264414514cdf45ac."},{"key":"e_1_2_8_5_1","unstructured":"National Medical Products Administration (NMPA) Center for Drug Evaluation \u201cNotice on the Release of the Guidance on the Application of Physiologically Based Pharmacokinetic Models in Pediatric Drug Development (2023 No. 24) \u201d(2023) https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/c1ccd4f7d92531ead702938347b75874."},{"key":"e_1_2_8_6_1","unstructured":"National Medical Products Administration (NMPA) Center for Drug Evaluation \u201cNotice on the Release of the Guidance on Quantitative Methodology for Extrapolating Adult Drug Data to Pediatric Populations (Trial) (2023 No. 27) \u201d(2023) https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/ce89e86db19fa67465b35e5c9c5fbf6a."},{"key":"e_1_2_8_7_1","unstructured":"National Medical Products Administration (NMPA) Center for Drug Evaluation \u201cNotice on the Release of the Guidance on Model\u2010Informed Dose Exploration and Optimization for Innovative Drugs (2024 No. 53) \u201d(2024) https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/3a55263f274e0525c1172a37f5b04a8e."},{"key":"e_1_2_8_8_1","unstructured":"National Medical Products Administration (NMPA) Center for Drug Evaluation \u201cNotice on the Release of the Guidance on Model\u2010Informed Development of Drugs for Rare Diseases (2025 No. 25) \u201d(2025) https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/6af9e335e63bbcfc762a3d191ff8b719."},{"key":"e_1_2_8_9_1","unstructured":"National Medical Products Administration (NMPA) Center for Drug Evaluation \u201cNotice on the Release of the Guidance on Exposure\u2010Response Relationship Research (2025 No. 29) \u201d(2025) https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/a42477dc1f21eefa630909030d2fd71a."},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265\u2010025\u201002167\u2010z"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13674"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262\u2010022\u201001209\u2010z"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11523-025-01149-1"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-023-01318-3"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/bjd\/ljaf455"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-018-0631-z"},{"key":"e_1_2_8_17_1","unstructured":"National Medical Products Administration (NMPA) Center for Drug Evaluation \u201cDetailed Information on Marketed Drug \u2010 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