药品政策法规、技术指南、制药科学与技术以及行业信息网站汇总

药政信息是制药行业必须关注的内容,它包括政策法规、技术指南、制药科学与技术以及行业信息与动态等。如何及时全面的获得药政信息至关重要,总结出如下网站供大家参考,方便大家查询。

1、美国
FDA官网:
https://www.fda.gov/about-fda
 
药政信息:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information
 
FDA所有指南的总地址:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents
 
CGMP问答:
FDA官网检索 Questions and Answers on Current Good Manufacturing Practices
 
DMF数据库检索和信息解读:
https://www.fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs
 
CAAPI DMF信息:
https://www.fda.gov/drugs/drug-master-files-dmfs/types-drug-master-files-dmfs
 
IID数据库检索技术-辅料信息
https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
 
溶出数据库:
https://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
 
橙皮书检索:
https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
 
警告信检索:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
 
紫皮书检索(生物类似药)
https://purplebooksearch.fda.gov/
 
FDA批准的药品:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
 
药品公司现行注册地址:
https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
 
CFR联邦法规:
https://www.ecfr.gov/cgi-bin/ECFR?page=browse
临床研究机构检索:
https://www.accessdata.fda.gov/scripts/cder/cliil/index.cfm
专利
http://www.freepatentsonline.com/
 
2、欧盟
EMA scientific advice检索:
https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance
 
EMA scientific guideline检索
https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines
 
EU GMP检索:
https://ec.europa.eu/health/documents/eudralex/vol-4_en
 
EU GMP问答:
https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers
 
审评报告检索:
https://www.ema.europa.eu/en/medicines/download-medicine-data#european-public-assessment-reports-(epar)-section
 
撤回申请检索:
https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Human/ema_group_types/ema_withdrawn_applications
 
EU GVP(药物警戒):
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices
 
EU药物警戒信息:
https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance
 
EDQM CEP申请指南检索:
https://www.edqm.eu/en/certification-policy-documents-guidelines
 
EDQM QA指南:
https://www.edqm.eu/en/quality-management-qm-documents
 
食品接触材料清单:
https://www.edqm.eu/en/food-contact-materials
 
CEP证书信息检索:
https://extranet.edqm.eu/publications/recherches_CEP.shtml
 
CRS常见问答:
https://faq.edqm.eu/display/FAQS/EDQM+Reference+Standards
EU RLD确定政策:
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/generic-medicines/generic-hybrid-applications
 
非EMA 批准药品的信息:
https://www.hma.eu/mriproductindex.html
 
3、英国
英国药监局官网:
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
 
MHRA药品审批信息:
https://products.mhra.gov.uk/
 
MHRA指南信息:
https://www.gov.uk/search/guidance-and-regulation
 
英国GMP相关指南:
https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice
4、WHO
WHO官网:
https://www.who.int/
 
WHO药品法规:
https://www.who.int/medicines/regulation/en/
 
WHO GMP 介绍:
https://www.who.int/bloodproducts/gmp/en/
 
检索大部分指南:
https://extranet.who.int/prequal/content/who-technical-report-series
 
PQ项目流程:
https://www.who.int/news-room/fact-sheets/detail/prequalification-of-medicines-by-who
 
WHO PQ产品目录:
https://extranet.who.int/prequal/content/prequalified-lists/medicines
 
API PQ名单:
https://extranet.who.int/prequal/content/active-pharmaceutical-ingredients-0
 
QC lab PQ名单:
https://extranet.who.int/prequal/content/medicines-quality-control-laboratories-list
 
WHO PQ检查报告:
https://extranet.who.int/prequal/content/prequalification-reports
 
检索企业的申报资料审评报告:
https://extranet.who.int/prequal/WHOPAR/ma044
 
PQ相关指南:
https://extranet.who.int/prequal/content/who-medicines-prequalification-guidance
 
PQ相关市场信息:
https://extranet.who.int/prequal/content/market-information
 
药理毒性信息:
https://www.who.int/ipcs/network/en/
 
5、PIC/S
PIC/S官网:
https://picscheme.org/
 
PIC/S指南:
https://picscheme.org/en/publications
 
PIC/S Members:
https://picscheme.org/ey77n/members
 
6、ICH
ICH官网:
https://www.ich.org/
 
ICH指南检索:
https://www.ich.org/page/ich-guidelines
 
7、APIC原料药行业协会
APIC 指南检索:
https://www.apic.cefic.org/publications.html
 
8、中国
国家药品监督管理局:
https://www.nmpa.gov.cn/
 
中国药典委员会:
https://www.chp.org.cn/
 
国家药品监督管理局药品审评中心
http://www.cde.org.cn/
中国食品药品检定研究院:
https://www.nifdc.org.cn/nifdc/
国家市场管理总局:
http://www.samr.gov.cn/

 

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声明:药研对本文观点保持中立,文章仅供交流学习使用,版权归原作者所有。

版权声明:菜芽君 发表于 2021年11月3日 下午12:53。
转载请注明:药品政策法规、技术指南、制药科学与技术以及行业信息网站汇总 | 药研导航

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