Table 1.

Conditions for Accepting Vaccines for Evaluation for WHO Prequalification and the Current Status of the Hepatitis E Vaccine

Condition	Current Status of Hecolin
The candidate vaccine is on the current list of priority products for UN prequalification.	Hecolin is included in this list.
The candidate vaccine meets the mandatory characteristics for programmatic suitability [5].	Hecolin is currently presented in monodose, non-autodisable, prefilled syringes, which is not in line with WHO-UNICEF joint statement for vaccine safety.
The NRA responsible for the regulatory oversight of the product has been assessed by WHO as "functional" and has been found to meet all the critical indicators defined for prequalification purposes.	The Chinese NRA has been assessed by WHO as a “functional” NRA in 2013.
An MA has been granted by the relevant NRA, and the postmarketing regulatory oversight is under the responsibility of the NRA of the country of manufacture.	Hecolin has been available in the Chinese market since October 2012.

Abbreviations: MA, marketing authorization; NRA, National Regulatory Authority; UN, United Nations; WHO, the World Health Organization.