The Swiss agency says the aim of the agreement is to bring “high-quality, life-saving medicines to patients as quickly as possible.”

The bill on new rules on companies holding minimum stock levels for “critical medicines” has been amended but is still likely to take effect at the beginning of July.

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.

Variant vaccine approvals can be based on manufacturing/quality and non-clinical data as long as data on earlier vaccines support the predictability of clinical immunogenicity and reactogenicity.

The EU and Korean authorities say the agreement will allow them to further develop moves towards mutual recognition and regulatory harmonization.

The European Health Data Space is expected to give researchers, industry and public bodies access to large amounts of high-quality health data for the development of new treatments and vaccines. The European Parliament has also approved new rules on Substances of Human Origin.