Regulatory Systems

Supply chain

Taking a Leap Toward Global Supply Chain Efficiency

Our biopharmaceutical manufacturers face a number of global supply chain challenges, when producing and delivering medicines and vaccines to patients around the world.

We advocate for regulatory system strengthening and convergence worldwide to allow timely and reliable access to medicines and vaccines. Maintaining supply chain assurance is an important component of a strong regulatory system.

Globalization has resulted in increasingly complex pharmaceutical supply chains; encompassing multiple geographical manufacturing, testing and distribution sites often needed to maximize production capacity to meet global demand.

Supply chain integrity and resilience are important components of patient access to medicines and vaccines, as disruptions can quickly lead to drug shortages or introduction of falsified products.

Flexibility is needed in supply chain manufacturing and distribution in order to respond to dynamic supply needs and to comply with evolving regulatory requirements.

Manufacturers need to make timely changes to implement new technologies that improve the availability, stability and/or the quality of medicines and vaccines.

Implementation of changes in medicines and vaccines is complicated by both the globalization of the supply chain and the divergence and occasional unpredictability of requirements and review timelines applied by each national regulatory authority.

Fragmentation is increasing in the supply of medicines and vaccines because of the more frequent occurrence of “pending regulatory approvals” (e.g., approval delayed with undefined timelines in some countries, and/or not granted at all in other countries).

Taking these six relevant aspects of supply chain is important to get the system in synchronization.


We believe that the complexity concerning the production and supply of medicines and vaccines, particularly for products that use a multinational manufacturing process, must be better communicated to regulatory authorities and other stakeholders.

300 days

from drug production to patient access

1.5 years

shortest timeline for drug licensure + 1 post-approval change

5.5 years

longest timeline for drug licensure + 1 post-approval change

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