EU Commission aims to reduce regulatory burden for pharmaceuticals
In its pharmaceutical package proposal, the Commission aims to simplify the regulatory framework for the development of new medicines and the repurposing of existing ones.
To incentivise pharmaceutical innovation and enterprise in Europe, the Commission has proposed simplifying the regulatory framework for the development of new medicines.
The proposal comes as part of its pharmaceutical package, which includes legislation on orphan drugs and paediatric medicines and a Council recommendation to step up the fight against antimicrobial resistance (AMR).
The package seeks to make medicines more available, accessible and affordable while supporting innovation and boosting the competitiveness and attractiveness of the EU pharmaceutical industry.
“[We] need to have a simpler and faster regulatory ecosystem,” EU health chief Stella Kyriakides told reporters on Wednesday (26 April). “So we will reduce the authorised authorisation procedures and timelines to ensure that medicines reach patients faster.”
Currently, the EU has relatively long approval times that span on average 400 days. In the US, for example, regulatory approval time takes 244 days. To address this, the Commission is proposing to more than halve the European Medicines Agency’s (EMA) assessment time, from 400 days to 180 days for standard procedures and 150 days for accelerated procedures.
“This will of course reduce administrative burden and save up to €300 million in costs companies and authorities,” Kyriakides said.
To address administrative burden and compliance costs for industry, the Commission aims to simplify procedures by abolishing marketing authorisation renewal in most cases and introducing simpler procedures for generic medicines. The use of digitisation, such as electronic submissions of applications and electronic product information, is also hoped to improve the process.
The Commission says that the highest quality, safety, and efficacy standards for the authorisation of medicines will be maintained.
“Without compromising safety, we will have reduced assessment time,” Kyriakides assured.
Additionally, the EMA will provide better early regulatory and scientific support for developers of promising medicines to facilitate fast approval and help SMEs and non-profit developers.
“We will have early scientific support for medicine development, especially SMEs, we will have Regulatory Sandboxes for exciting new treatments, and companies will be able to submit their doses for authorisation in the digitalised way so this will be faster and much lighter,” Kyriakides said.
EMA committees will be reduced from five to two “to make the entire operation more predictable, less demanding on resources both through EMA and member states,” the health Commissioner said. Additionally, patients’ representatives will be included in EMA committees for medicines approval.
“In this way, where the reform will make the EU as a more attractive place to invest and develop medicines, while ensuring that we reach patients faster, including children and those suffering from Rare Diseases,” Kyriakides said.
Political discussions on the pharmaceutical package will continue in the Parliament and the Council before its approval.
[Edited by Nathalie Weatherald]
