The development of China’s vaccine industry in the past decade: the perspective from drug regulatory science

Figures & data

Table 1. Legal and regulatory documents mainly related to vaccines (2011–2020)

Year	Major changes in laws and regulations
2011	Measures for the administration of adverse drug reaction of reporting and monitoring (Order No. 81 of the Ministry of Health)
	Good Manufacturing Practice for Drugs(2010 Revision) (Order No. 79 of the Ministry of Health)
2013	Guidelines for Quality Management of Vaccine Clinical Trials (Trial) (CFDA[2013] No. 228)
	Regulations on the Administration of Quality Accreditation of Disposable Vaccine Clinical Trial Institutions (CFDA[2013] No. 248)
2014	Regulations on Reporting Severe Adverse Events in Vaccine Clinical Trials (Trial) (CFDA[2014] No. 6)
	Guidelines for Research on Quality Comparability of Vaccine Production Site (CFDA[2014] No. 1)
2015	Guidelines for Stability Research of Biological Products (Trial)
	Guidelines for Research on Quality Comparability of Vaccine Production Site
2016	Regulations on the Administration of Vaccine Circulation and Vaccination (Revised and implemented on April 23, 2016)
2017	Regulation Code for Management of Vaccine storage and transportation (2017 version)
	Provisions for the Lot Release of Biological Products (2017 version) (Order No. 39 of CFDA)
2019	Vaccine Administration Law of the People’s Republic of China was promulgated and implemented for the first time
	Pharmaceutical Administration Law of the People’s Republic of China (2019 Revision)
	Guidelines for Changes in Production Process of Vaccine for post marketing (Draft for Comments)
2020	Provisions for Drug Registration (State Administration for Market Regulation, Order No. 27)
	Provisions for the Supervision and Administration of Drug Production (State Administration for Market Regulation, Order No. 28)
	Provisions for the Lot Release of Biological Products (2020 version) (State Administration for Market Regulation, Order No. 33)
	Guidelines for Research and Development of SARS-CoV-2 Vaccines (Trial)
	Key Technical Points of Non-Clinical Efficacy Study and Evaluation of SARS-CoV-2 Preventive Vaccine (Trial)
	Guidelines for Clinical Research of SARS-CoV-2 Preventive Vaccines (Trial)
	Guidelines for Clinical Evaluation of SARS-CoV-2 Preventive Vaccines (Trial)
	Guidelines for Pharmaceutical Research Technology of SARS-CoV-2 mRNA Vaccine (Trial)

Table 2. Classification list of vaccine batches issued varieties in China

Classification	Vaccine type	The route of transmission of the disease	Specific vaccine varieties
Monovalent and multivalent vaccines	Viral vaccines	Arthropod-borne	Yellow fever live attenuated vaccine, Inactivated tick-borne encephalitis vaccine, Hemorrhagic fever vaccine (vero cells, Golden hamster kidney cells and Gerbils kidney cells), Rabies vaccine (vero cells, human diploid cells and Golden hamster kidney cells), Japanese encephalitis vaccine (live attenuated or inactivated)
		Respiratory transmission (aerosol)	Seasonal influenza vaccine, Rubella vaccine, Live attenuated measles vaccine, Mumps vaccine, Varicella vaccine, Zoster vaccine
		Fecal-oral transmission	Polio vaccine, Rotavirus vaccine (monovalent and pentavalent), EV71 vaccine, Hepatitis A vaccine, Hepatitis B vaccine, Hepatitis E vaccine
		Sexual transmission	Human papillomavirus vaccine (2-valent, 4-valent and 9-valent)
	Bacterial vaccines	Respiratory transmission (aerosol)	BCG vaccine, Pneumococcal vaccines (7-valent, 13-valent and 23-valent), Meningococcal polysaccharide or conjugate vaccine (A, C, AC and ACWY), Hib conjugated vaccine
		Fecal-oral transmission	Recombinant B-subunit cholera vaccine, Typhoid vaccine
		Other	Tetanus vaccine, Leptospira vaccine
Combined vaccine	Virus vaccines	Fecal-oral transmission Respiratory transmission(aerosol)	Hepatitis A and Hepatitis B combined vaccine MMR combined vaccine, Measles and Rubella live attenuated combined vaccine, Measles and Mumps live attenuated combined vaccine
	Bacterial vaccines	Fecal-oral transmission Respiratory transmission (aerosol)	Acellular DPT and Hib combined vaccine, Adsorbed diphtheria and tetanus combined vaccine, Adsorbed DPT combined vaccine
	Virus and bacterial vaccines	Fecal-oral transmission Respiratory transmission (aerosol)	Adsorbed acellular DPT and inactivated poliomyelitis and Hib combined vaccine

Figure 1. Overall vaccine listing in China from 2011 to 2020.

Figure 2. Overall listing of NIP and non-NIP vaccines in China from 2011 to 2020.

Table 3. Newly launched vaccine in China from 2011 to 2020

Year	Newly vaccine varieties
2011	Hepatitis E vaccine, 7-valents pneumococcal polysaccharide conjugated vaccine (PPCV)
2014	MenAC-Hib
2015	Inactivated polio vaccine (Sabin strain)
2016	Inactivated EV71 vaccine
2017	2-valents HPV vaccine, 4-valents HPV vaccine, 13-valents PPCV, Recombinant Ebola virus vaccine
2018	Pentavalent rotavirus vaccine, Quadrivalent inactivated influenza vaccine, 9-valents HPV vaccine
2019	Recombinant zoster vaccine
2020	SARS-CoV-2 vaccine*

*The vaccine was approved for emergency use.

Figure 3. Overall listing of combined vaccines in China from 2011 to 2020.

Table

NMPA	National Medical Products Administration
Ch.P.	Pharmacopoeia of the people’s Republic of China
R&D	Research and Development
NIFDC	National Institute for Food and Drug Control
WHO	World Health Organization
EV71	Enterovirus Type 71
DPT	Diphtheria, Pertussis and Tetanus
NIP	National Immunization Program
MMR	Measles Mumps and Rubella
Hib	Haemophilus influenzae type b
ACYW135	Meningococcal groups A, C, Y and W135
PPCV	Pneumococcal polysaccharide conjugated vaccine
HPV	Human papillomavirus
HMFD	Hand-Foot-Mouth Disease