Professor Stefan Vieths, president of Germany's Paul-Ehrlich-Institut (PEI), explains how Europe's most specialised biomedicines regulator is navigating a period of rapid transformation. Vieths traces the PEI's 130-year evolution from a serum-testing institute into the federal authority overseeing vaccines, blood products, and advanced therapies; examines how Germany's Medical Research Act is cutting clinical trial approval times and repositioning the country as a destination for innovative research; and sets out how the PEI is adapting its regulatory approach for ATMPs, where the traditional batch-testing model no longer applies. He also discusses ZEPAI, the pandemic preparedness centre established within the PEI, and the institute's growing international footprint — from regulatory capacity-building in Africa to securing Europe's vaccine production infrastructure.
Those outside of Germany might not realise the distinction between your institute (which regulates biomedicines such as vaccines, blood products, and gene therapies) and the BfArM (chemical drugs). How did this model evolve, and what benefits does it bring?
The Paul-Ehrlich-Institut has a 130-year history, the foundation of which goes back to Paul Ehrlich himself and his work. Today, the Paul-Ehrlich-Institut is the Federal Institute for Vaccines and Biomedicines, a higher federal authority operating under the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). The current division of responsibilities between the Paul-Ehrlich-Institut and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is the result of a historically developed and later legally anchored specialised strategy for Germany’s regulation of medicinal products: even the predecessor of the Paul-Ehrlich-Institut, the Institute for Serum Research and Serum Testing founded in 1896 with Paul Ehrlich as director, focused on sera. These products are still under the responsibility of the Paul-Ehrlich-Institut.
In 1899, the Institute moved to Frankfurt am Main to the newly opened Royal Institute for Experimental Therapy (Königliche Institut für experimentelle Therapie), where the official examination of all therapeutic sera subject to state control was part of its tasks. An independent scientific and regulatory tradition for biomedicines developed out of this early institutional anchoring of state control of vaccines and serum preparations at the beginning of the 20th century. The Institute was renamed the Paul-Ehrlich-Institut in 1947 and became an independent higher federal authority in 1972. In 1990, the Paul-Ehrlich-Institut moved to its current location in Langen near Frankfurt. With the reorganisation of the higher federal authorities in the course of the dissolution of the Federal Health Office (Bundesgesundheitsamt) in the 1990s, the specialised strategy was further reinforced in the applicable pharmaceutical law: The BfArM was created in 1994 and the Paul-Ehrlich-Institut took over responsibilities for blood and blood preparations from the former Federal Health Office. The Paul-Ehrlich-Institut has also been responsible for advanced therapy medicinal products (ATMPs) since 2004.
The division of tasks between the Paul-Ehrlich-Institut and BfArM is thus based on a deliberately chosen and legally regulated professional differentiation according to medicinal product classes. This differentiation was developed from different scientific traditions and the respective specific regulatory requirements. While the Paul-Ehrlich-Institut today has the expertise for sera, vaccines, blood preparations, tissues and tissue preparations, allergens, ATMP, xenogeneic medicinal products, and genetically engineered blood components, the BfArM takes over the regulation of all other human drugs.
The special advantage of this structure lies in the consistent bundling of highly specialised scientific and regulatory expertise along different medicinal product classes. Biomedicines in particular place special demands on quality assurance, scientific evaluation and advice, and monitoring due to their diversity as well as their extremely complex manufacturing processes and mechanisms of action. These requirements can be addressed in a particularly well-founded manner by the Paul-Ehrlich-Institut as a specialised higher federal authority that conducts in-house research.
Functional differentiation thus strengthens the scientific quality of regulatory decisions, increases the efficiency of procedures, ensures a high level of safety, efficacy and quality of medicines, and has also proven itself in European and international contexts. Both institutes work closely together in partnership and use their respective expertise for the benefit of patients.
And what is the PEI’s mission today?
The people’s health is at the heart of our tasks and activities.
The Paul-Ehrlich-Institut is committed to the quality, efficacy, and safety as well as the availability of vaccines and biomedicines. The Institute examines and evaluates these medicinal products along their entire life cycle, approves clinical trials in Germany, and grants marketing authorisations.
Its in-house research supports regulatory tasks by researching model medicines and developing new methods. With the founding of the Center for Pandemic Vaccines and Therapeutics (Zentrum für Pandemie-Impfstoffe und -Therapeutika, ZEPAI) in 2021, the Paul-Ehrlich-Institut also became responsible for pandemic preparedness and pandemic response measures using pandemic vaccines and therapeutics.
As part of regulatory scientific advice procedures, the Institute supports pharmaceutical developers and records and assesses incidents of certain in vitro diagnostic medical devices, approves performance studies, and is an EU reference laboratory (EURL) for three groups of high-risk infection tests. In addition, the Paul-Ehrlich-Institut provides the public with information on the topics within its remit that is scientifically sound and easy to understand.
Germany is by far the leading country in Europe for speed of access to innovation; under the AMNOG system, once the EMA approves a drug, it is typically available and reimbursed in German pharmacies on Day 1. What does this mean for the PEI’s role as a national biomedicine regulator?
Medicinal products to be marketed in Germany first require an official authorisation in the form of a national authorisation or a centralised authorisation.
The European Medicines Agency (EMA) coordinates the centralised authorisation procedure in the European Economic Area (EEA). The scientific assessment of the documents on the quality, efficacy and safety of medicines that must be submitted with the application for authorisation is carried out by experts from the national medicines authorities of the Member States, such as the Paul-Ehrlich-Institut. For each authorisation application, the Committee for Medicinal Products for Human Use (CHMP) at the EMA issues a final opinion recommending the authorisation or refusal of a medicinal product for human use. The European Commission (EC) will decide on the authorisation on the basis of this recommendation.
After the marketing authorisation has been granted, a medicinal product can be placed on the German market immediately. Medicinal products used in outpatient care can then be prescribed and expenses are covered by the statutory health insurance companies. The subsequent early benefit assessment in accordance with the Act on the Reform of the Market for Medicinal Products (Arzneimittelmarktneuordnungsgesetz, AMNOG), on the other hand, serves to assess the added value compared to existing therapy options and to determine a reimbursement amount in the statutory health insurance system. The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is responsible for this assessment. It makes a decision on the added value on the basis of an expert opinion from the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG). The AMNOG procedure for the early benefit assessment and pricing of new medicinal products begins when the medicinal product enters the market or is first placed on the market in Germany.
A structured scientific exchange takes place between the Paul-Ehrlich-Institut and the BfArM, the higher federal authorities responsible for the authorisation, and the G-BA, responsible for the benefit assessment. This exchange allows for scientific questions on clinical studies to be coordinated at an early stage. The aim is to plan studies in such a way that they provide meaningful data for both authorisation and the subsequent benefit assessment. The responsibilities and decisions of the respective institutions remain separate.
In addition, one of the central tasks of the Paul-Ehrlich-Institut regarding the availability of many biomedicines is official batch testing and release. In this context, the Paul-Ehrlich-Institut thoroughly examines production batches of allergens, blood plasma products, immunoglobulins, vaccines, and sera from donor animals, and releases them for the German market if they meet the safety, efficacy, and quality criteria specified in their marketing authorisation. However, the Paul-Ehrlich-Institut is not normally involved in the retail chain from manufacturers to wholesalers to pharmacies.
Germany’s declining clinical trial numbers led to the creation of the Medical Research Act at the end of 2024. This Act aims to speed up the application and negotiation process and enhance coordination between authorities. In 2026, how different is the way that PEI works with researchers?
In the Paul-Ehrlich-Institut’s area of responsibility, the number of new applications submitted for the approval of a clinical trial has increased in the last 15 years. The number of applications increased from 265 in 2011 to 392 in 2025.
The aim of the Medical Research Act (Medizinforschungsgesetz, MFG), which came into force on 30 October 2024, is to increase Germany’s overall attractiveness as a location for innovative medical research and to expand it in a sustainable manner. The Paul-Ehrlich-Institut and the BfArM play a central role in this process. In order to keep up with the rapid speed of innovation in medicinal product development and medical technology, cooperation between research institutes, companies, and regulatory authorities will be intensified.
The MFG makes a notable difference by facilitating and accelerating cooperation with applicants and researchers. At the BfArM, a central coordination office was set up with the aim of coordinating and harmonising cooperation between the Paul-Ehrlich-Institut and the BfArM in the areas of scientific advice, medicinal product authorisation procedures, and approval of clinical trials. Applicants benefit from the central coordination office, the shortened procedure times for the approval procedures for mononational studies, the use of complementary assessment expertise to optimally bundle technical expertise, and the joint application portal for national consultations. Researchers and pharmaceutical companies can now find their way to the competent authority even faster through a joint application portal. Digital application and communication platforms support efficient interaction and the role of the authorities as partners and technical consultants. Overall, the MFG enables an even more coherent, service-oriented and accelerated monitoring of clinical research projects.
Are we seeing a real reduction in the time it takes to get a trial started in Germany?
The conduct of a clinical trial in the European Union (EU) is subject to approval pursuant to the Clinical Trials Regulation (EU) No. 536/2014 (CTR). Before the MFG, the regular evaluation period for mononational clinical trials in accordance with the CTR was generally 45 days. The MFG established a shorter processing time for mononational clinical trials in section 40, subsection 4 of the Medicinal Products Act (Arzneimittelgesetz, AMG). After successful validation, initial applications must be assessed within 26 days by the responsible higher federal authority and the responsible ethics committee, which corresponds to a shortening of the processing time by 19 days. If an application has no deficiencies, approval is possible as early as day 31, which is a significant benefit for the applicants.
The ethics committees, as well as the Paul-Ehrlich-Institut and the BfArM, also guarantee shortened deadlines when processing mononational modification notifications. This guarantee means that a decision on a defect-free application will be issued 24 days after successful validation at the latest.
The MFG and the introduction of the Standard Contractual Clause Regulation on the rights and obligations of the sponsor and the trial centre when conducting a clinical trial are also intended to minimise the duration of contract negotiations, so that clinical trials can begin more quickly after approval.
We are entering the era of Personalised Medicine, where ATMPs such as CAR-T cell therapies can be tailored to an individual patient’s genetic makeup. How is the PEI adapting its regulatory framework for products that don’t fit the traditional ‘batch-testing’ model of industrial manufacturing?
Advanced therapy medicinal products (ATMPs) are complex, heterogeneous and differ from existing medicinal products in their nature, qualities, and manufacture. ATMPs include gene therapeutics, somatic cell therapeutics, and tissue-engineered products. They provide innovative ways to treat disease and injury. The EMA’s centralised authorisation procedure is mandatory for ATMPs, so their regulation is governed directly by EU legislative frameworks.
The Paul-Ehrlich-Institut adapts its regulatory frameworks and activities to the unique characteristics of ATMPs, focusing on supporting manufacturers throughout the entire lifecycle from development to manufacture and beyond. This support includes consulting on manufacturing and testing processes, evaluating non-clinical and clinical data, and monitoring product safety, efficacy, and quality. The Paul-Ehrlich-Institut relies on EMA regulatory guidelines relevant to ATMPs while providing support to manufacturers. This approach enables a flexible testing and authorisation concept that accommodates the unique characteristics of these therapies while maintaining rigorous safety and quality standards for patients.
To date, personalised medicinal products such as CAR-T cells have been produced predominantly using the respective patient’s own cells. With these medicinal products in particular, the variability of the starting material, for example, due to a patient’s prior treatment, can significantly impact the quality of the final product. Therefore, the greatest possible flexibility must be applied in the regulatory assessment.
The PEI’s international footprint is expanding through projects like VaccTrain, which supports the development of regulatory authorities in Africa. Why is it in Germany’s interest for the PEI to act as a ‘regulatory diplomat?’
Germany has a great interest in institutes such as the Paul-Ehrlich-Institut acting as “regulatory diplomats” because health knows no borders – especially in an increasingly globalised world. Strengthening global health systems and regulatory capacities also directly contributes to health security in Germany.
VaccTrain and VaccRelease are projects under the BMG’s Global Health Protection Programme (Programm für globale Gesundheitssicherheit, GHPP). The programme, which was launched in 2016, aims to utilise the scientific expertise of German federal institutes such as the Paul-Ehrlich-Institut internationally in order to strengthen both national and global health security. A particular focus is on the prevention and management of epidemics and pandemics.
Within the framework of the GHPP, the Paul-Ehrlich-Institut participates in the VaccTrain and VaccRelease projects as a scientific-regulatory implementing and partner institution. Both projects aim to sustainably strengthen regulatory systems in African partner countries and to build resilient structures for the planning, approval, conduct, and evaluation of clinical trials. Such adaptable regulatory systems are essential in order to be able to deal with health crises more quickly and effectively in the future. VaccTrain focuses in particular on strengthening scientific and regulatory competencies for the approval, evaluation, and control of clinical trials, as well as for the pharmacovigilance of vaccines and biomedicines. In addition, the projects support the development of sustainable regulatory structures for the conduct and monitoring of clinical trials, medicinal product safety, and official batch release of vaccines. At the same time, they promote expertise in the evaluation of applications for clinical trials and in official batch release procedures, thus improving authorities’ ability to respond to health crises.
VaccTrain also contributes to the harmonisation of regulatory processes in Africa and strengthens Regional Centres of Regulatory Excellence (RCOREs) in Egypt, Ghana, Kenya, Zimbabwe, and South Africa. The Paul-Ehrlich-Institut thus makes an important contribution to global health security and universal access to safe and effective vaccines. At the same time, Germany also benefits directly from this exchange: international cooperation flows into the Paul-Ehrlich-Institut’s own scientific and regulatory competencies in the field of vaccine research and safety, international networks expand, and preparedness for cross-border health threats improves.
How does this cooperation help stabilise global supply chains for essential vaccines?
The development of a sustainable vaccine industry in emerging and developing countries requires a robust regulatory system for the authorisation and monitoring of medicinal products in these countries. By building up scientific and regulatory competencies in African partner countries, projects such as VaccTrain contribute to improving access to safe and effective vaccines, which is critical for the stability of global supply chains.
One of the most significant structural changes at the PEI in recent years was the establishment of ZEPAI. In 2026, we are no longer in a state of pandemic emergency, but ZEPAI remains active. How are you working with industry to ensure that Germany remains ready to flip to mass vaccine production if needed?
The core task of the Center for Pandemic Vaccines and Therapeutics (ZEPAI) is to build an infrastructure between pandemics to ensure the rapid supply of safe and effective vaccines and therapeutics to the population should a pandemic occur. This infrastructure will enable ZEPAI to coordinate and support supply efforts during a pandemic.
ZEPAI works closely with partners at the national, European, and international levels, such as the European Health Emergency Response Authority (HERA), pharmaceutical wholesalers, logistic and transport service providers for vaccine distribution, and the pharmaceutical companies with which pandemic preparedness contracts have been concluded (BioNTech, IDT Biologika and Wacker/Corden Pharma).
In the event of a pandemic, these pandemic preparedness contracts guarantee Germany the right to draw upon permanently reserved vaccine production capacities from the contracted companies, totalling 146.9 million doses of mRNA vaccines and 80 million doses of vector vaccines per year. The reserved production capacities include the availability of important raw materials, production lines, and personnel. All essential manufacturing steps are prepared so that vaccine production can be ramped up within a very short time if there is an acute need. ZEPAI provides continuous support to the companies, auditing their respective pandemic preparedness plans, monitoring their implementation, and evaluating whether a company is ready for a pandemic and can enter the pandemic preparedness phase.
At the European level, ZEPAI is involved in the European Vaccines Hub for Pandemic Readiness (EVH). ZEPAI’s main contribution to the EVH is its expertise from the national pandemic preparedness infrastructure and vaccine production, for example in the preparation of the EVH pandemic preparedness plan. Especially against the background of the recent Ebola infections, it is clear that European cooperation in pandemic prevention is essential.
In an emergency, ZEPAI also coordinates the procurement, storage, and nationwide distribution of vaccines and other medicinal products in Germany on the basis of pre-established storage capacities and stable distribution channels. Through this close partnership between government, science, and industry, ZEPAI creates the conditions to best prepare Germany for future pandemics and to enable a rapid and resilient response.
Do you have a closing message for our audience?
Embedded in an international network, the Paul-Ehrlich-Institut defines its core mission as the science-based evaluation, authorisation, and monitoring of vaccines and biomedicines, with the ultimate goal of ensuring quality, efficacy, and safety for the public. Its actions are grounded in scientific excellence, methodological rigour, and continuous innovation in both research and regulatory assessment.
In this role, the Institute sees itself as an independent, transparent, and responsible higher federal authority that communicates its decisions clearly and fosters an open, collaborative dialogue with experts and the general public. Transparency and scientific integrity are central pillars of its institutional identity.
The Paul-Ehrlich-Institut views health as a global responsibility. In close cooperation with national and international partners, it contributes to the advancement of regulatory standards and the management of cross-border health issues. International networking and cooperation are essential prerequisites for driving innovation and strengthening health protection worldwide – because health knows no borders.
