The Guidelines is meant to provide technical guidance for the R&D of therapeutic drugs for primary biliary cholangitis (PBC). The Guidelines only applies to R&D of chemical drugs and therapeutic biological products. When applying the Guidelines into practice, stakeholders should also refer to Good Clinical Practice (GCP), ICH's guidelines, and other technical guidelines issued in or outside China.

The Guidelines only represents drug administrations' current knowledge and opinions. It does not have legal effects. With the development of scientific researches, the Guidelines will be improved and updated continually.