In its proposal for pharmaceutical legislation, the European Commission seeks to simplify the regulatory framework for the development of new medicines and the reuse of existing medicines.
In order to encourage pharmaceutical innovation and enterprise in Europe, the Commission has proposed to simplify the regulatory framework for the development of new medicines.
This proposal is part of its pharmaceutical package, which includes legislation on orphan drugs and pediatric medicines, as well as a Council recommendation to step up the fight against antimicrobial resistance (AMR).
This package aims to make medicines more available, more accessible and more affordable, while supporting innovation and enhancing the competitiveness and attractiveness of the EU pharmaceutical industry.
“We need to have a simpler and faster regulatory ecosystem,” EU Health Commissioner Stella Kyriakides told reporters on Wednesday (April 26). “We are therefore going to reduce authorization procedures and delays so that medicines reach patients more quickly. »
Today, authorization times in the EU are relatively long, averaging 400 days. In the United States, for example, the regulatory approval time is 244 days. To remedy this situation, the Commission proposes to reduce by more than half the evaluation period of the European Medicines Agency (EMA), which would therefore drop from 400 days to 180 days for standard procedures and to 150 days for accelerated procedures.
“This will of course reduce the administrative burden and save up to 300 million euros in costs for businesses and authorities,” added Ms. Kyriakides.
To reduce the administrative burden and compliance costs for industry, the Commission is seeking to simplify procedures by abolishing the renewal of marketing authorization in most cases and introducing simpler procedures for generic drugs. The use of digitization, such as electronic submission of applications and digitized product information, should also improve the process.
The Commission says the highest standards of quality, safety and efficacy for the authorization of medicines will be maintained.
“Without compromising security, we will reduce evaluation times,” assured Ms. Kyriakides.
In addition, the EMA will provide better early regulatory and scientific support to developers of promising drugs to facilitate rapid approval and help SMEs and not-for-profit developers.
“We will have early scientific support for drug development, especially for SMEs, we will have regulatory airlocks for interesting new treatments, and companies will be able to submit their doses for authorization in a digital way, which will be faster and much easier. lighter,” said Ms. Kyriakides.
EMA committees will be reduced from five to two “in order to make the whole operation more predictable and less demanding in terms of resources, both at EMA and Member State level”, said the commissioner to health. In addition, patient representatives will be included in the EMA’s drug approval committees.
“In this way, the reform will make the EU a more attractive place for investment and the development of medicines, while guaranteeing faster access to patients, including children and people suffering from rare diseases”, said added Mrs. Kyriakides.
Political discussions on the pharmaceutical package will continue in Parliament and Council before its approval.
This article is originally published on euractiv.fr