Vision

We strive to take a leading role among medicines agencies in Europe.

Mission

We are the national competent authority for regulation of medicinal products, medical devices, blood and tissues and a partner to competent authorities and agencies throughout Europe.

Self-concept

• We are dedicated to promoting and protecting both human and animal health by safeguarding and shaping the regulatory and scientific environment to ensure high-quality medicinal products and medical devices with a balanced benefit-risk ratio.
• Our scientific and regulatory experts are the knowledge carriers of our organisation. Therefore, we conceive ourselves as a learning and teaching organisation.

Responsible

We are committed to working for the health of humans, animals, and plants in a sound and responsible manner. We stand by our actions and decisions.

Objective

We are guided by facts, are impartial, and act with integrity.

Competent

We do the right things, and we do them in a service- and results-oriented manner. As a team, we strive for innovation, interdisciplinarity, and excellence.

European

We live and promote the European idea. We actively participate in shaping the European regulatory environment, thereby contributing to safeguarding health in Europe.

Ensuring impartiality

AGES MEA is entrusted by the Health and Food Safety Act (GESG) with the execution of the tasks of the Federal Office for Safety in Health Care (BASG).

Pursuant to § 8 (7) GESG, the acceptance of third party contracts is prohibited for this business division. AGES MEA thus operates independently of parties whose activities are regulated by the material laws under the jurisdiction of the BASG. The services of the BASG are available to all applicants and notifiers who are entitled under the material laws. The procedures shall be applied without discrimination. The fees to be paid are determined by the BASG according to applicable legal requirements.

AGES MEA's legal status ensures that its personnel are kept free from any influences that might affect their professional judgment. The AGES MEA experts act on behalf of the BASG and in this capacity are subject to the duty of truth, against which the right to issue instructions cannot penetrate. The personnel is obliged to secrecy, impartiality and the protection of confidential data.

The employees of AGES MEA may not be involved in the development, production or distribution of the drugs or medical devices they review and may not be owners or authorized representatives of interested parties in the field of their professional activities in AGES MEA in the execution of the above-mentioned material laws. They shall not engage in any activity which may adversely affect the independence of their judgment or their integrity in the performance of their duties.

Pursuant to Directive 2001/83/EC, Article 126b and Section 82a of the German Medicines Act (AMG), all employees of the BASG and the AGES MEA are obliged to submit annual declarations to the BASG regarding any grounds for bias. The criteria used for the evaluation are the AVG § 7 and the "European Medicines Agency policy on the handling of competing interests of scientific committees' members and experts" of the European Medicines Agency; the evaluation process follows a guideline of the Heads of Medicines Agencies.

These criteria defined for the implementation of the Medicines Act are also applied analogously for the implementation of other material laws within the competence of the BASG (Medical Devices Act, Blood Safety Act, Tissue Safety Act and Addictive Substances Act).

Strategic field of action 1: Innovation
1.1 Recognising technological innovations and product innovations in the pharmaceutical environment
1.2 Structured analysis of these findings and derivation of evidence-based decisions 
1.3 Further training of our employees and development of expertise in the analysed areas of innovation

Strategic field of action 2: Resilience and agility
2.1 BASG / Austrian Medicines and Medical Devices Agency must be able to adapt quickly to changing external circumstances
2.2 Creation of structures that enable rapid action and reaction to external influences
2.3 Establishment of "rapid organisation/solution teams"

Strategic field of action 3: Ensuring expertise in the long term
3.1 Building up new expertise based on the findings from field of action 1
3.2 Develop measures to retain expertise in the agency
3.3 Expand processes for knowledge transfer when knowledge holders leave the company

Strategic area of action 4: Digitalisation and AI
4.1 Continue digital transformation and digitalise processes
4.2 Evaluate new technological possibilities and integrate them into processes where appropriate
4.3 Carry out initial pilots

Strategic field of action 5: External image
5.1 Establish a new public register of authorised medicinal products
5.2 Improve enquiry management
5.3 Drive forward proactive communication
5.4 Evaluate and utilise communication channels

Strategic field of action 6: Financing
6.1 Evaluate financing models and develop new ones
6.2 Analyse and optimise processes
6.3 Securing financing