Review of the pharmaceutical legislation: the proposals of the industrial associations

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The current situation of pharmaceutical supply chain is often difficult, there are many challenges to face linked to the production process and technologies, lack of geographical diversification and it feels urgent the need to unlock the potential of data to improve supply and demand predictability.

In this article we resume shortly some of the latest proposal arising from the main industrial associations, you can read more about it in this article on EIPG website.

The European Federation of Pharmaceutical Industry Associations published a report in 2022 to illustrate its proposal to improve efficiency of the supply chain. Epidemiological data are deemed essential in order to better analyse patient demand and to improve transparency in the overall supply chain; targeted shortage prevention plans should be developed to prevent the risk of shortages for critical products. The maintenance of global open supply chain should be the ultimate goal, supported by the strong existing EU manufacturing and R&D footprint.

The current revision of EU pharmaceutical legislation is a golden opportunity to reverse the trends of the last 25 years. It is our once-in-a-generation chance to reinvent the regulatory framework to ensure we have a modern approach that matches our ambition to be a hub of medical innovation”, writes EFPIA’s director general Nathalie Moll in a recent post, published on the association’s website.

Another important goal for EFPIA is to achieve a more agile and streamlined regulatory framework, to shorten the period needed for approval of new active substances (426 days in Europe vs 244 days in the USA). The transition from paper leaflets to electronic product information should be also supported within the new pharmaceutical legislation.