Global regulatory requirement and considerations for pharmaceutical co-crystals
10.13699/j.cnki.1001-6821.2025.02.029
- VernacularTitle:国外药物共晶的监管要求介绍及思考
- Author:
Jing PAN
1
;
Xiao-yan WANG
1
;
Xiao-long HUANG
1
Author Information
1. 国家药品监督管理局药品审评检查大湾区分中心,广东 深圳 518017
- Publication Type:Journal Article
- Keywords:
pharmaceutical co-crystals;
drug regulation;
drug research
- From:
The Chinese Journal of Clinical Pharmacology
2025;41(2):296-300
- CountryChina
- Language:Chinese
-
Abstract:
As a new solid-state form of drugs,pharmaceutical co-crystals can improve the physicochemical properties of drugs(such as melting point,stability,solubility,hygroscopicity,compressibility,permeability,bioavailability,etc),thereby changing drug performance or enhancing therapeutic efficacy,providing new ideas for drug development.In recent years,pharmaceutical co-crystals has attracted much attention as a hot topic in the research of crystalline drugs,but there is currently no specialized guiding principle for pharmaceutical co-crystals research in China.This article mainly investigates the technical documents on pharmaceutical co-crystals research released by the Food and Drug Administration(FDA)and the European Medicines Agency(EMA),elaborates on the regulatory requirements for pharmaceutical co-crystals in foreign countries,compares and analyzes the regulatory requirements of FDA and EMA,in order to provide references for the research and regulation of pharmaceutical co-crystals in China.
