UK BIA To Lobby New EU Parliament On Need For Close Regulatory Ties After Brexit
The BioIndustry Association wants to discuss the importance of close post-Brexit regulatory alignment with the new European Parliament and will also press its message on the next leader of the Conservative Party after prime minister Theresa May steps down.
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The reduction in the European Medicines Agency’s activities since the UK voted to leave the EU nearly three years has impaired the regulator's ability to keep up with scientific and regulatory developments, and it is facing more staff losses as a result of its relocation to the Netherlands. However, the agency says it has managed to safeguard its core activities relating to the evaluation and supervision of medicines, and that the EU regulatory network should be able to adapt to Brexit-related changes without jeopardizing the quality of its work.
An agreement to delay Brexit has brought no reprieve for the pharmaceutical sector, which must remain at a heightened state of preparedness as a no-deal scenario is still a possibility. Industry says it will seek clarity on the practical implications of this.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.