This is a collection of China’s recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities: National…
ANDA: abbreviated new drug application; NDA: new drug application; BLA: biologics license application Legal Basis of ANDA, NDA, BLA Registration and R…
Pharmacovigilance is an important obligation for life sciences companies. Pharmacovigilance (PV), also known as drug safety, should be monitored throu…
Market access strategy is significant to win in the target market. A good market access strategy enables pharmaceutical companies to provide safe and …
DMF: Drug Master File; API: Active Pharmaceutical Ingredient Legal Basis Drug Administration Law of the People’s Republic of China (2019 Revision); Pr…
CTA: clinical trial application; BE study: bioequivalence (BE) Study; MRCTS: multi-regional clinical trials Legal Basis Drug Administration Law of the…
E-commerce market in China has become one of the most developed ones in the world, accordingly, the competition is fierce. Well-functioning ecosystem …
From Nov. 1, 2022, China National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as …
To market over-the-counter (OTC) drugs in China, stakeholders used to obey the same documentation requirements and marketing authorization application…
