Faster Market Access for Medicinal Products: Re-Thinking of Approval Procedures in the EU!
Nothing is more valuable than time - especially in the field of supply with medicinal products, where patients need to be provided with the appropriate medicines quickly and effectively. Every single second here can be precious and even make the difference between life and death, yet the development and approval of new medicinal products with new active ingredients is a lengthy and complex process. It is the complexity of the approval procedures that often leads to delays with potentially serious consequences. The planned reform of EU pharmaceutical legislation addresses precisely this point: its aim is to make the EU regulatory system for medicines more efficient and flexible in order to speed up the development and approval of medicines and improve the availability of medicines to patients. We will take a closer look at exactly how this challenging balancing act is to be achieved in the following sections.
From OTC products to specialized therapeutics, pharmaceuticals cover a broad spectrum of medical needs. Their development is the result of decades of scientific work, innovation and significant financial investment, all aimed at improving human health and quality of life. A critical milestone in this process is the approval of new medicines. The approval process ensures that every new drug brought to market has undergone rigorous quality, efficacy and safety testing. This review process is carried out by regulatory agencies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the U.S., but also by national authorities. These authorities oversee the entire development process, from initial research to market launch, and ensure that medicinal products meet the highest standards.
However, due to its complexity and duration, the approval process can cause significant delays in making new therapies available to patients. These delays are particularly problematic for the treatment of serious or life-threatening diseases, as any delay has the potential to have a serious impact on patients' lives and, in the worst case scenario, may even cost lives.
To address this challenge, the planned reform of EU pharmaceutical legislation aims to make the EU regulatory system for medicines more efficient and flexible.
Package of measures to promote timely approval and availability of medicinal products under the reform!
The reform includes a number of measures aimed at supporting the development, timely approval and availability of medicines to patients. These include:
- strengthening scientific support prior to submission of marketing authorization applications:
Under the reform, the European Medicines Agency will provide drug developers with enhanced scientific support prior to the submission of marketing authorization applications. This is intended to improve the quality of initial applications and reduce delays due to missing information. Incomplete applications will be invalidated in the evaluation process if the missing data are not submitted by the deadline. This results in optimized use of resources and expedites evaluations for approvals. - shortening evaluation and approval timelines:
To ensure timely access to medicines for patients, the deadlines for scientific evaluation and approval of medicines will be shortened. Under the proposed reform, the evaluation period would be reduced from the current 210 days to 180 days. The period for the Commission to approve a drug is to be reduced from 67 to 46 days. For medicines of particular interest to public health, the assessment period is even to be reduced to 150 days. In this way, the current average of 400 days between application and approval will be shortened. These shortened deadlines, in combination with strengthened scientific support, will ensure faster access of medicines for patients. - improving the structure and governance of the EMA:
As part of the reform, the structure and governance of the EMA will be improved. This includes simplifying the scientific committees and strengthening their expert-based capacity. These measures will avoid duplication of work, increase efficiency and shorten assessment times for medicines. At the same time, high standards and scientific expertise will be maintained. - simplification of regulatory procedures and promotion of digitization:
The reform intends to simplify regulatory procedures and promote digitization. This will lead to a reduction in the administrative burden for drug developers and competent authorities. For example, electronic submission of applications and product information in electronic format will be made possible. These measures will make the process more efficient and facilitate cooperation between the parties involved.
Revision of EU pharmaceutical legislation: A breakthrough in Marketing Authorisations for Medicinal Products!
The planned revision of EU pharmaceutical legislation promises to revolutionise the approval process for medicines. With a combination of efficient measures, the EU regulatory system will be made more flexible to speed up the availability of life-saving medicines for patients. Strengthened scientific support, shortened assessment timelines, and improved governance will ensure timely access to high-quality medicines. The proposed revision represents a promising future for drug approval by focusing on getting medicines to market quickly to improve patients' health and quality of life.
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Note: The blog article is based on the European Commission's press releases of
November 25, 2020 and April 26, 2023