AstraZeneca

AstraZeneca commends the European Commission for adapting the diagnostic regulatory framework to keep pace with technological advances and an expanding evidence base, enabling more timely access to high-quality diagnostics.

AstraZeneca welcomes the Biotech Act as a timely and important initiative to strengthen EUs regulatory framework for attracting investments in advanced medical R&D through improving clinical trial conduct and innovation incentives. More ambition is essential to overturn the decade-long decline in EUs share in commercial clinical trials and its erosion of intellectual property rights by the NPL.

AstraZeneca welcomes the European Commissions efforts to strengthen the competitiveness of the European biopharmaceutical industry through the Biotech Act. It is an important opportunity to enhance sector competitiveness and to unlock the transformational impact of biopharmaceutical innovation on peoples lives.

The document promotes cross border interoperability of public services and health data access bodies. The nuances of interoperability of different platforms needs to be detailed to include privacy and security for patient information. Further collaboration and information exchange need to be defined at a high level. For example, who will upload the information, and where is it uploaded?

In pharmaceutical research, a large number of substances are used in the synthesis of drug candidates. Many of the substances used for the synthesis of drug candidates can also potentially be used to synthesize narcotic drugs. In some Member States, applications for authorization to handle substances classified as drug precursors must be submitted annually.