Introduction:

Quimi-Hib®, a Cuban vaccine obtained by chemical synthesis and unique in the world, required its own regulatory strategy because there is no guideline on the requirements for its production and control.

Objective:

To characterize the regulatory strategy of the pre-launch phase of Quimi-Hib® in Cuba.

Material and Methods:

Descriptive-retrospective study of the requirements for the approval of the Cuban vaccine. Seven strategic steps were established to cover current and future regulatory standards based on expert advice for decision making. The starting point was the WHO´s guideline, which applies to anti-Hib vaccines of natural origin.

Results:

The regulatory strategy was developed based on the 15 recommendations of the aforementioned guideline, 11 of which were extrapolated to the Cuban vaccine and four of which were not, but served as the basis for the development of four requirements with similar rationale that apply to the semisynthetic vaccine.

Six additional requirements were added, three of which were requested from the Cuba's National Regulatory Authority and three of which were obtained from the available relevant literature. These 21 requirements complete the regulatory package, the result of the strategy developed for this vaccine and the subsequent approval for marketing authorization and commercialization.

Conclusions:

The regulatory strategy compensates for the lack of specific guidelines for synthetic Haemophilus influenzae type b vaccines and thus contributed to the approval of the first vaccine of this type. The regulatory strategy is flexible because it includes update requirements throughout the vaccine life cycle, and expert consensus was considered in its development.

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