Commission executive vice president Margrethe Vestager asserts that the future prosperity of Europe’s biotech sector hinges on streamlining the regulatory process, aiming to expedite product approvals and bolster competitiveness.
Commission’s Actions Unveiled
The European Commission has unveiled a series of initiatives geared towards enhancing biotechnology and biomanufacturing within the EU, confirming earlier reports leaked by Euronews. One key aspect of this plan involves a thorough evaluation of current regulations governing the approval of biotech products in the market, with the objective of refining the EU regulatory framework to ensure smoother implementation.
Addressing Regulatory Disparities
Vestager acknowledges significant disparities in approval timelines between the US and the EU, citing examples where biotech products can take six to eight years for approval within the EU compared to two to three years in the US. She highlights the streamlined approval process employed for COVID-19 vaccines as a model that could be replicated for biotech products, emphasizing the importance of real-time data assessment to expedite approvals without compromising safety standards.
Industry Response and Calls for Action
In response to the Commission’s proposal, EuropaBio, the largest biotech association in the EU, emphasizes the urgent need to translate rhetoric into concrete policy and legislative actions to foster competitiveness. The statement underscores the critical role of regulatory reform in facilitating innovation and attracting investment to the European biotech landscape.
Collaborative Governance and Policy Coherence
The European Federation of Pharmaceutical Industries (EFPIA) calls for a comprehensive strategy that encompasses coordinated governance and strategic alignment across various sectors, including research, health, industry, and internal market policies. This collaborative approach is deemed essential for ensuring policy coherence and breaking down existing silos to promote synergy and efficiency in advancing the biotech sector within the EU.
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