April Wang
April Wang is Regulatory Affairs Manager at Accestra Consulting.
*This article was prepared by April Wang from Accestra Consulting which provides China regulatory affairs consulting and DMF for APIs, excipients and packaging material. For questions, please contact us by email: info@accestra.com or visit website: www.accestra.com.
JournalOverview of chemical generics registration in China: Challenges for overseas applicants
This is the fifth article in a six-part series that focuses on the regulations in China’s drug market. There will be different topics each month with the initial focus on the drug master file (DMF) filing process followed by the drug registration process and pharmacovigilance requirements.
JournalComparing China Drug Master Files with the EU and US
This is the third article in a six-part series that will focus on the regulations in China’s drug market. There will be different topics each month with the initial focus on the drug master file (DMF) filing process followed by the drug registration process and pharmacovigilance requirements.
JournalChina drug master file: registration pathways and requirements
This is the first article in a six-part series that will focus on the regulations in China’s drug market. There will be different topics each month with the initial focus on the drug master file (DMF) filing process followed by the drug registration process and pharmacovigilance requirements. ...