Immunization standards

National regulatory authority of China meets international standards for vaccine regulation

1 March 2011

A WHO-led team concluded today, at the end of a comprehensive review by experts from six countries, that the national regulatory authority of China, the State Food and Drug Administration (SFDA), and affiliated institutions, meet WHO published indicators for a functional vaccine regulatory system.

Effective regulatory oversight of vaccines is essential since vaccines are used on a population-wide basis, and are usually given to healthy infants. Furthermore, vaccines are produced in only a small number of countries and often exported from the country of manufacture to many countries. Countries importing vaccines need to be confident that the national regulatory authority in the country of origin is competent in its oversight. WHO has established benchmarks that define international expectations for a functional vaccine regulatory system. WHO also conducts regular external audits of national regulatory authorities, particularly in vaccine-producing countries, to ensure that the regulatory systems meet the necessary standards, and that the system is maintained and functions in a sustainable way.

The regulatory functions of the SFDA and its affiliated institutions (including the Centre for Disease Control and Prevention of the Ministry of Health) were assessed for compliance against the WHO indicators. In addition to the general framework for the system, the following regulatory functions were evaluated: marketing authorization and licensing; post-marketing surveillance, including for adverse events following immunization; lot release by the national regulatory authority; laboratory access; regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials.

Today's conclusion is the culmination of 19 months of intensive effort by the SFDA to implement a roadmap — developed by national experts, with continuous advice from WHO — to strengthen capacity for regulation of vaccines.

With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for Prequalification of specific products. WHO prequalification, which is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy, is a prerequisite for manufacturers to supply to countries through United Nations procuring agencies. Each application for prequalification of a specific product is independently evaluated by WHO. It is expected that vaccines from China could be prequalified 1-2 years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers is expected to have a significant, beneficial impact on global supply of vaccines of assured quality.

As for all NRA assessments, sustainability of the gains made in regulatory capacity is critical. For this purpose, the team which has just completed the assessment in China has drawn up a detailed institutional development plan and will soon discuss a roadmap towards submission of applications from manufacturers for prequalification of individual vaccines. The plan outlines additional activities to be undertaken to further strengthen regulatory capacity in China. The Ministry of Health has already approved the plan and discussions are planned to guide Chinese manufacturers in preparing for submisssions for prequalification to WHO. WHO is committed to providing further support to assist the regulatory authority in making continuous improvements.

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