5.4 Single Package and Label

Regulatory expectations for packaging and labelling vary among countries and reviewers to include country specific languages and edits to address individual agency and reviewer preferences.  These differences make it impossible to use the same packaging and labelling components for all countries and to shift inventory among countries in response to the epidemiology of a disease.  Exact order quantities must be known months ahead of supply of the product.  Manufacturers often fill orders for countries with the highest potential revenue first and there may be significant delays of months to years in filling orders for countries with lower potential revenue. 

Use of the same packaging and labelling components would provide the greatest potential for equitable access to new medicines, biologics, vaccines and devices.  During the COVID-19 pandemic, many regulators waived country specific packaging and labelling requirements to facilitate product distribution.  A Q/R code could be used on the components to allow users to access a website that would contain country specific languages and edits (e.g. reconstitution information), if needed, although the more customization is requested, the higher the risk of delays in product availability. 

Flexibility in country specific and reviewer specific packaging and labelling requirements is needed to facilitate product distribution. Convergence of requirements in peacetime would eliminate the need to negotiate requirements in the event of a public health emergency and would allow printing well in advance the packaging elements.