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Draft Royal Decree regulating the Strategic Action Plan to reduce the risk of selection and spread of antibiotic resistance and its national plans
Last week, the Ministry of Health released for public consultation the Draft Royal Decree regulating the Strategic Action Plan to reduce the risk of selection and spread of antibiotic resistance and its national plans.
With the aim of improving Spain's commitment to the fight against antimicrobial resistance, this text seeks to provide coverage and regulation for the strategic and action plan to reduce the risk of selection and spread of antibiotic resistance. To this end, it provides for the establishment of a solid regulatory framework for those aspects that lack regulation, improving coordination in the implementation of national strategies, in line with those derived from the international sphere.
The deadline for submitting contributions is 10 August 2025.
Electronic processing of import and export authorisations for investigational medicinal products
The Spanish Agency for Medicines and Medical Devices (AEMPS) has launched an electronic system for managing applications for the import and export of medicines for human use for clinical trials authorised in Spain.
A notable new feature is the improvement in agility, as it will now be possible to submit a single annual application for each investigational medicinal product, rather than submitting an application for each shipment.
This new feature can be found in the AEMPS's Import and Export of Medicines for Human Use application.
Approval of the creation of the State Public Health Agency (AESAP)
Last week, the Congress of Deputies finally passed the law creating the State Public Health Agency (AESAP), which aims to improve preparedness and response to future health crises. The AESAP also aims to strengthen the capacities of the Ministry of Health and the autonomous communities to improve the health of the population and reduce inequalities, under the principle of ‘One Health’, which encompasses human, animal and environmental health.
In addition, the approval of this law, which will be published in the Official State Gazette in the coming days, has been widely welcomed by the industry, as it provides for the existence of incremental innovation in medicines, which includes further developments on existing drugs. This explicit recognition, which is also provided for in the draft Medicines and Health Products Law currently being processed, is important because until now there have been no incentives in Spain for pharmaceutical companies to invest in this type of innovation.