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Approval times for medicines are set to be cut by an average 30 days in Europe following an agreement by the European Commission, European Parliament and the Council of the European Union to update 20-year-old pharmaceutical legislation.
In a statement published on 11 December 2025, the Council of the European Union said the reform simplifies a number of laws that have been introduced at different times, which will “strengthen competitiveness and innovation while keeping strict safety standards in place”.
It added that streamlining procedures would speed up supply chains and bring new medicines to market more quickly, boost innovation, with stronger incentives for novel products and tackle medicines shortages through better monitoring and co-ordination.
The pharmaceutical legislation reform was first proposed by the European Commission in April 2023.
In a statement also published on 11 December 2025, the European Medicines Agency (EMA) said: “This represents the most significant overhaul of the regulatory framework in over two decades and is a once-in-a-generation opportunity to reshape medicines regulation in the EU.”
The simpler regulatory environment will “facilitate reduced assessment time (210 to 180 days) and free up scientific resources to strengthen pre-authorisation support to medicine developers”, the statement said.
“Marketing authorisation for a medicine will be valid by default for an unlimited period, avoiding the unnecessary administrative burden linked to renewals unless required on safety grounds by EMA’s scientific committees,” it added.
Commenting on the latest legislation update, Emer Cooke, executive director of the EMA, said: “By simplifying procedures, embracing digitalisation and rationalising our use of scientific resources, we will be better positioned to support innovation and ensure that promising new treatments reach patients faster.
“The new legislation also provides us with the tools to deliver on our network strategy to 2028 and address the major public health challenges of the future, from antimicrobial resistance to emerging health threats.”
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has eliminated backlogs in approvals for new medicines.
According to MHRA data, timescales for regulatory decisions for medicines in January 2024 were an average of 333 days for national routes (application for a UK, Great Britain or Northern Ireland marketing authorisation), outside the statutory timescale of 210 days.
For reliance routes — the procedure that allows the MHRA to grant a licence, which relies on approval in the EU — a decision took an average of 195 days, versus the statutory timescale of 67 days, the data revealed.
However, in a statement published alongside data on 13 December 2024, the MHRA said it had eliminated the backlogs and was assessing applications within expected timescales.
The EMA said it plans to publish a new website page that will serve as a central repository of information on implementation of the new legislation.
