CFDA sees the implementation of the revised vaccine distribution and procurement regulations as a way to address the shortages. The regulator is encouraging staff at all levels of its organization to both adopt the aspects of regulations that are relevant to their jobs and encourage manufacturers and distributors to bring their practices in line with the new policies. Officials have created the new regulations to end the conditions that allowed organizations to supply improperly stored vaccines for years.
The enforcement of the new regulations is seen as preventing such illegal activities and supporting the supply of safe, effective vaccines. In its notice calling for staff to work toward this goal, CFDA also mentioned some other actions it wants its offices to take. Specifically, CFDA wants its staff to step up their supervision, inspection and product sampling activities. CFDA’s ambitions for such work extend beyond the identification of noncompliant organizations. The regulator also sees the actions as an opportunity for regulators to work with the vaccine industry to raise standards.
CFDA wants its staff to actively help companies to solve the problems they identify. In doing so, the regulator thinks it can help the industry achieve sustained and stable output of vaccines. Specific areas in which CFDA wants to see its staff provide regulatory support include the construction of cold chain logistics networks. Such work will serve two purposes: The presence of a functioning cold chain could lead to the elimination of improperly stored vaccines from the supply chain, while also helping to ensure that logistics capacity constraints never restrict the availability of products.
The regulator also used the notice to address issues outside its traditional areas of focus. Officials are concerned the storage scandal has affected consumer confidence in the safety and efficacy of vaccines. As such, CFDA is encouraging its staff to work to raise awareness about the importance of vaccinations. The regulator is also urging manufacturers to do their part. CFDA wants companies to establish and stick to production schedules, even if temporary sales difficulties tempt them to cut or stop output.
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