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2025 Annual Work Plan of the Spanish Agency of Medicines and Medical Devices
Last Monday, the Spanish Agency for Medicines and Medical Devices (AEMPS) published its 2025 Annual Work Plan, which includes all the activities planned for this year.
Its objectives include:
- Strengthening the Agency's position in Europe and Latin America.
- Ensuring the supply of medicines for human use.
- Combating antibiotic resistance.
- Improving information and communication technologies.
European framework for improving scientific evidence established by health technology assessment agencies and the EMA
The agencies responsible for the evaluation of health technologies, including the Spanish Agency of Medicines and Medical Devices (AEMPS), together with the European Medicines Agency (EMA), have published a report with agreed conclusions and key recommendations to strengthen scientific evidence, establishing a framework for European collaboration with the aim of promoting synergies between regulatory assessment and health technology assessment, in line with the provisions of Regulation (EU) 2021/2282.
Among the points identified between health technology assessment agencies and regulatory agencies, the following stand out:
- Early dialogue during the drug development process could help identify evidence needs.
- Improvements in the collection, analysis, and reporting of outcomes other than the primary endpoints of clinical trials can substantially reduce uncertainty in decision-making.
- Better data sharing, both from clinical trials and from registries and observational studies with real-world data, could help regulatory agencies and health technology assessment agencies interpret scientific evidence.
Agreement reached to establish an international treaty aimed at improving the response to future pandemics
Last week, an agreement was reached between the member countries of the World Health Organization (WHO) to establish an international treaty aimed at improving the response to future pandemics. The agreement aims to improve prevention, preparedness, and response to future pandemics on a global scale.
The Ministry of Health defends changes to the Law on Medicines and Medical Devices
Last week, César Hernández and Javier Padilla appeared before the media to respond to criticism of the draft bill on medicines and medical devices.
Surprised by the criticism received during this first week since the publication of the draft, against the selected pricing system, the Ministry of Health defended the incorporation of historically demanded innovations such as the inclusion of incremental innovation and accelerated financing procedures prior to the financing decision and affirmed that the changes made are in line with the Pharmaceutical Industry Strategy.