High-risk R&D projects by SMEs alone or in cooperation with public and private universities, non-university research institutions, other companies and other partners are to be funded. First-time applicants and SMEs that have been less active in research are also explicitly included. The aim is to facilitate the entry of SMEs into demanding BMBF programmes and to win new SME target groups for R&D. The BMBF will also provide funding for research and development projects. The funding covers projects for the research and development of medicinal products. The funding is intended to support companies in the implementation of innovative projects that could be delayed or not realised at all without funding.

The funding focuses on industrial research and pre-competitive development projects in the field of medical biotechnology that address a high medical need and have a high scientific and technical risk. The projects are intended to support SMEs in expanding and strengthening their position on the national and international market. The application reference must clearly emerge from the research subject. A key objective of BMBF funding is to promote the accelerated transfer of technology from pre-competitive areas to practical application.
The following priority areas and fields of application in the field of drug development are eligible for funding, but no claim to completeness is made:

• Development, optimisation and automation of screening methods for drug development, including the search for new lead structures or the optimisation of existing lead structures.
• Development of platform technologies for drug development.
• Development of experimental disease models for drug development.
• Development of methods to analyse or improve the pharmacokinetics, pharmacodynamics and safety profile of active substances that have significant advantages over existing solutions and are intended to maximise the potential of the active substance or enable its use.
• Development of medicines using artificial intelligence.
• Development of predictive models to analyse the efficacy and safety of active substances.
• Manufacturing of investigational medicinal products in accordance with Good Manufacturing Practice (GMP) guidelines.
• Preclinical development up to the development of a clinical drug candidate and demonstration of clinical proof-of-concept (clinical trials up to and including phase IIa are eligible).
• Clinical trials for "repurposing".

Stand-alone funding of companion diagnostics without accompanying drug development or companion diagnostics for drugs already on the market is excluded. Research and development of in vitro diagnostics according to the EU Regulation 2017/746 on in vitro diagnostics are not eligible for funding, with the exception of the above-mentioned companion diagnostics. The development of biosimilars is excluded from funding.
Projects in the field of medical technology, including the research and development of medical devices such as implants and medical equipment, are not the subject of this funding announcement and are therefore not eligible for funding. Materials research should not be the main focus of the work. Projects for the development of products and diagnostics subject to Regulation (EU) 2017/745 on medical devices are excluded from funding

Eligible applicants are commercial enterprises that meet the definition of a small or medium-sized enterprise (SME) according to the EU SME definition. When the funding is disbursed, the company must have a permanent establishment or branch in Germany. The classification as an SME is made by the applicant and is declared in the written application to the granting authority. Companies can obtain further information on the SME definition from the Federal Government's "Research and Innovation" funding advisory service.
In collaborative projects with the above-mentioned companies, universities and universities of applied sciences, non-university research institutions, SMEs (less than 1,000 employees, less than €100 million annual turnover) and other partners may also be eligible to apply.
Large companies cannot be funded directly under this call, but they can and should be integrated as associated partners in the collaborative projects if they represent an indispensable link in the subsequent value chain.

The grants are awarded by way of project funding as a non-repayable subsidy. The amount of the grant per project is based on the requirements of the project applied for within the framework of the available budget funds.
SMEs can apply for at least 50% funding.
The procedure has two stages. A project outline of 10 pages can be submitted on two deadlines (15.4. and 15.10). The project outline should contain the following sections:

• Topic and objective of the project
• State of the art in science and technology and own preliminary work, property rights situation with regard to the object of research and development, medical potential also in comparison to competing approaches.
• Necessity of the grant: scientific-technical and economic risk, justification of the need for government funding
• Market and exploitation potential, competitive situation
• Brief description of the project participants and companies applying for funding (foundation, number of employees, annual turnover, total number of property rights held by the company), expertise, brief description of competencies at research institutions
• Description of the business model and the company's own contribution to be made.
• Work plan including milestones and work packages of all partners involved and, if applicable, network structure
• Financing plan
• Exploitation plan taking into account market prospects, economic and scientific-technical prospects for success, economic utilisation possibilities and scientific connectivity, particularly in Germany, with a time horizon.

If the outline is successfully evaluated, the applicant will be invited to submit a full proposal.