The State Food and Drug Administration (SFDA) issued in October Technical Guideline for Pre-Clinical Research of Preventive Vaccines, Technical Guideline for Process Change Management of Biological Products Manufacturing, Technical Guideline for Pre-Clinical and Clinical Research of Combined Vaccines, Technical Guideline for Production and Quality Control of Polypeptide Vaccines, Technical Guideline for Quality Control and Clinical Research of Conjugate Vaccines, and Guideline for Rating Scales of Adverse Reaction of Clinical Trials of Preventive Vaccines. These guidelines are developed by SFDA in accordance with the Drug Administration Law, the Regulations for Implementation of the Drug Administration Law and the Provisions for Drug Registration of the People's Republic of China to standardize the research and development of vaccines and offer scientific guidance to vaccine developers in their research.

Technical Guideline for Pre-Clinical Research of Preventive Vaccines comprises seven parts: preamble; basic principles; bacterial strains for vaccine research; process study of vaccine production; pharmacology, toxicology and biological distribution; quality control and test requirements; and sample requirements for clinical research.

Technical Guideline for Process Changes Management of Biological Products Manufacturing includes preamble, principles, and overviews.

Technical Guideline for Pre-Clinical and Clinical Research of Combined Vaccines includes preamble; points to consider on the research and development, manufacturing, test, and clinical research of combined vaccine.
Technical Guideline for Production and Quality Control of Polypeptide Vaccines comprises five parts: preamble, chemosynthesis of polypeptide vaccines, manufacturing process and quality control of polypeptide vaccines, product quality and test requirements, and pre-clinical safety assessment.

Technical Guideline for Quality Control and Clinical Research of Conjugate Vaccines includes preamble, quality control principles of conjugate vaccine production, and clinical research of conjugate vaccines.

Guideline for Rating Scales of Adverse Reaction of Clinical Trials of Preventive Vaccines includes preamble, overviews, and rating scales of adverse reactions.