Amgen

Amgen welcomes the Commissions efforts to undertake targeted simplification measures for the MDR and IVDR. For drug device combination products (DDC), we see three main opportunities for efficiency gains: 1) Non-integral products (intended to be used exclusively with a medicinal product): Under current legislation, integral devices (e.g., prefilled syringes) are reviewed mainly by medicines authorities with limited…

Amgen welcomes proposals in the Regulation shortening CHMP opinion timelines to 180 days, allowing reliance for inspections, streamlining of PRIME, and establishing regulatory sandbox. Moreover, Amgen welcomes the supply chains provisions currently included in the Regulation as they will ensure an EU wide approach to address supply chain challenges. We offer the following recommendations: Art.

Amgen welcomes this opportunity for commenting and offers the following recommendations: Art. 4(26): Clarify that in vitro diagnostics are not included within the definition of a combination of a medicinal product with a product other than a medical device. The definition should be revised to: 26) ...

Amgen supports an agile regulatory framework for EU to become more competitive and attractive for innovation globally. We are concerned that some proposals would not help achieve the roadmap goals and suggest approaches below (indent letters refer to EC roadmap section B) b) We propose: -Reduce regulatory approval times and costs: develop a more efficient marketing authorisation; shorten time to CHMP opinion by…

Amgen, one of the world's leading biotechnology companies, welcomes the opportunity to share our views on the upcoming EU Biotech Act and how this can ensure Europe stays competitive globally. As a company founded in the 1980s that rapidly grew to a multinational pharmaceutical company with operations in more than 100 countries, we believe we can bring valuable experience to the table.

Amgen welcomes the European Commissions ambition to strengthen Europes leadership in biotechnology and biomanufacturing through the Biotech Act II. As one of the worlds leading independent biotechnology companies operating across global manufacturing and supply networks, with a strong presence in Europe, we appreciate the important steps taken under Biotech Act I to address regulatory and industrial policy…

Amgen welcomes the European Commissions ambitions for the upcoming Innovation Act. As a global biotechnology company with a strong European presence, we are committed to advancing scientific breakthroughs and ensuring they translate into meaningful outcomes for patients.

Amgen appreciates the opportunity to provide our comments on the Proposal for an Extension of the Transitional Provisions for Certain Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). Amgen commends the European Commission for its proposal to protect access to on-market devices and IVDs and strongly supports efforts to extend the transition period for these products.

We welcome the opportunity to provide comments on the European Commission’s initial impact assessment on Regulations for medicines for children and rare diseases (RD). Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise.