European Drug Regulatory 2025 strategy focuses on drug accessibility and supply chain challenges

The European Medicines Agency (EMA) and the European Union Drug Agency (HMA) released the Drug Regulatory Network Strategy 2025 on 8 December, with drug access and access to the EU drug regulatory network over the next five years at the top of the agenda, followed by innovation, supply chain challenges, and antimicrobial resistance.
and strategy were also released in the same time as the analysis and summary of the results of the draft strategy (108 pages of documents are available for reading in the forest), the draft strategy was released in July this year.
strategy looks at how regulatory networks will continue to ensure the availability of drugs that meet patient needs as science, medicine and digital technologies evolve.
strategy considers the experience of regulatory flexibility introduced during the New Crown (COVID-19) pandemic, as well as the impact of globalization and the threat of other potential emerging health problems.
2025 strategy was developed in consultation with the European Commission and its main topics are in keeping with the European Drug Strategy issued by the Commission on 25 November, with the aim of modernizing and adapting the EU-led drug legislative framework to the future.
"The COVID-19 pandemic highlights the critical role of drug regulation in protecting public health," said Emer Cooke, Executive Director of the EMA 2020/11/17, which highlighted the issue of generic competition and compulsory licensing in the EU's drug strategy.
"the lack of available drugs, whether due to lack of market available or supply disruptions, has shown a "serious threat to patient and animal health,"" he said.
strategy ensures that "we work together across the EU to bring tangible improvements to our citizens."
the HMA management team, Thomas Senderovitz, said, "We must keep pace with social change and development so that we can continue to use existing resources and knowledge effectively to successfully accomplish our mission."
strategy document is a living document that will help us work together across networks to achieve this goal. The six key priority areas of the EU drug network described in the
strategy include: drug availability and accessibility data analysis and digital transformation of innovative antimicrobial resistance and other emerging health threats Supply chain challenge network sustainability and availability In the analysis of the results of the strategy, the section of the strategy on drug availability and accessibility received the most feedback from stakeholders (118), and some stakeholders stressed the need to increase transparency in the drug production and distribution chain.
, the strategy was revised accordingly to clarify that "greater transparency in listing status will enable regulators to better monitor the supply chain and anticipate potential problems with the supply of key products."
, in turn, will help drugmakers better understand regulators' expectations for transparency related to supply chain monitoring and will also help health technology assessment (HTA) agencies.
reviewers have asked the EU for a list of key or essential drugs.
regulators found it difficult to develop such a list because not all member states had approved all medicines and sold them on the market, but said the strategy had been revised elsewhere to highlight the role of the EMA in coordinating the activities of the European Drug Regulatory Network, monitoring and coordinating the availability and availability of medicines.
since the release of the draft strategy, drug reuse has become a key way to find potential treatments for COVID-19.
EMA and HMA said the final strategy now states that drug reuse and re-development should be considered in crisis situations to support drug affordability.
Innovation on Innovation, there were 100 responses, including feedback on not limiting "innovation" to new drugs, as well as consideration of innovation in the generics section and the use of new or improved drugs and technologies.
strategy has been revised accordingly to make it clear that the drug regulatory network will support the use of existing drug re-development for adaptation in areas where demand is not being met.
While the draft version addresses the issue of patient participation in innovation, the final strategy has a more specific statement that patients need "appropriate involvement" throughout product development and life cycle to ensure patient-centred while protecting public health and drug availability.
Data Analytics and Digital Transformation There are 85 reviews on data analytics, digital tools, and digital transformation, including some on the importance of data acquisition and transparency.
strategy has been revised to emphasize "the need for clear guidelines for collecting and storing data at the patient level."
" feedback also found that the strategy's recommendations to promote pan-European standards for real-world data between 2020 and 2025 were "unrealistic".
Thus, while the draft strategy already contains the objective of cooperation with international organizations in the area of big data, in view of certain responses, the scope of cooperation has been expanded in the final strategy, including with general external stakeholders (e.g., industry, patients, academia and non-governmental organizations) and with international regulatory bodies.
63 responses to supply chain challenges, most of which supported the objectives outlined in the strategy, but "stakeholders are not always able to agree on the objectives to achieve strategic objectives."
many of the reviews related to the prevention of counterfeit drugs, the coordination of post-approval changes, and the relocation of pharmaceutical manufacturing, which the EMA and HMA said were already covered in the strategy.
feedback that it is not the regulator's responsibility to help support the introduction of Pharmaceutical 4.0, including the use of advanced digital and intelligent machines in production facilities.
but the EMA and HMA insist that regulators can provide support "by participating in ICH and developing and implementing appropriate guidelines" and that "the ultimate goal is the public interest."
reviews mentioned the need for regulatory frameworks in areas such as inspections, microscopic supply chains and distributed manufacturing, coordination of GDP guidelines, change, supply chain resilience and diversification.
regulator said: "The strategy paper covers this to some extent, but has also been revised to highlight the need for an adaptive regulatory framework to promote innovation and investment."
" feedback on antimicrobial resistance and other health threats was 61 related to antimicrobial resistance and other emerging health threats.
many of the reviews called for a "coherent and widely applicable European-level policy" for developers of new antibiotics and for new tools and methods to reward investment in this area.
, however, the EMA and HMA said that "although highly relevant", this was an issue to be addressed "at a policy level, including the EU drug strategy".
EMA and HMA said their joint strategy was designed to serve as a "high-level umbrella document" to guide their work over the next five years.
will determine actions, schedules, and measurable results and include them in the EMA and HMA's multi-year work plans.
" in addition, an oversight team may be established to assess the implementation and implementation of the joint strategy.
" and will regularly submit progress reports to the HMA and EMA Management Committees.
will review the strategy after 18 months "to consider whether the objectives and objectives are still appropriate and to adapt them to environmental change and continued engagement with stakeholders."
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