Drugs imported for human use are required to obtain pre-market approval from the China Food and Drug Administration (CFDA) before being placed on the Chinese market. This requirement applies to all drug products (medicines), including innovative drugs and generic or over-the-counter (OTC) drugs. A drug substance or active pharmaceutical ingredient (API) also requires pre-approval by the CFDA.
The definition of “drugs” in China covers chemical and biological products (vaccines, blood products and biotech products, etc.) and herbal medicines. Pharmaceutical products are commonly referred to as “chemical drugs” under Chinese legislation.
The main focus of this guide will be on imported chemical drugs for registration in China. For overall consistency, the term “pharmaceutical products” is used throughout this guideline, with other types of drugs referred to specifically. A summary of biological products and the differences between the registration requirements of chemical drugs is provided in this report.