Welcome to the Frankfurt Foundation Quality of Medicines

Every day, medicinal products make a decisive contribution to prevent diseases – especially serious ones – or alleviating ailments, extending the life expectancy of patients and improving their quality of life. In addition to our high expectations of the efficacy and safety of medicines, the pharmaceutical quality of the products is also particularly important with regard to patient care.

The Frankfurt Foundation Quality of Medicines (FFQM) is committed to promoting research activities that are designated to optimally assure the quality of medicinal products in Germany and Europe or, if necessary, further improving them, especially if they are manufactured outside the country. Main concern is the development of advanced processes, the implementation of innovative technologies and their standardization as well as a critical verification of quality assurance concepts.

Download the FFQM flyer here (PDF-File, ~200kB)

Recent news

July 12, 2025 · Prices and Awards

Lifetime Achievement Award presented to Professor Amidon.

With this award, the Frankfurt Foundation Quality of Medicines (FFQM) recognizes the extraordinary achievements of Professor Gordon L. Amidon (University of Michigan, Ann Arbor, USA) in the field of pharmaceutical sciences and his outstanding contributions to improving the quality and efficacy of medicinal drugs.

The award ceremony took place during the symposium “Advances in Predictive Biopharmaceutics, Drug Product Quality and Patient Benefit” on July 11, 2025, in Mainz, a joint event organized by Johannes Gutenberg University (JGU) and the FFQM.

In his laudatory speech, Prof. Peter Langguth, pharmaceutical technologist at JGU, highlighted Dr. Gordon Amidon’s scientific contributions, which have improved the understanding of drug absorption and significantly influenced the assessment of the equivalence of generic drugs through in vitro studies. He played a decisive role in the development of the Biopharmaceutical Classification System (BCS) and its regulatory implementation as the BCS-based biowaiver concept.

Professor Langguth, his students, and the FFQM congratulate the award winner on this well-deserved honor.

July 8, 2025 · News

FFQM commented ICH M13B Draft Guideline

Together with experts of the EUFEPS (European Federation for Pharmaceutical Sciences) Network on Bioavailability and Biopharmaceutics, the German Pharmaceutical Society (DPhG) and the House of Pharma and Healthcare, Frankfurt, the Frankfurt Foundation Quality of Medicines prepared comments on the draft ICH M13B guideline. These comments and proposed amendments have been submitted to the European Medicines Agency (EMA).

The new guideline regulates options for justifying the waiver of additional bioequivalence studies in the development of medicinal products with multiple strengths. It thus represents a first supplement to the general ICH Bioequivalence Guideline M13A (https://www.ema.europa.eu/en/ich-guideline-m13a-bioequivalence-immediate-release-solid-oral-dosage-forms-scientific-guideline).

The experts recommended clarifications to certain regulations, e.g., the need to conduct in vitro comparative studies using multiple batches and regarding the rounding of mean results. Specific proposals for changes were submitted on the following topics:

Ignoring certain excipients (e.g., odorants or flavorings) that are not expected to affect BA/BE when determining a dose-proportional composition of strengths
Definition of “high-potency” drug products in the case of fixed-dose combinations
Biowaivers in the case of later extensions of a product line with additional dose strengths
Comparison of dissolution profiles between dose strengths and verification of their “comparability”
Methods for bootstrapping

All comments and proposed amendments submitted to EMA will be published on the EMA website in due course. The revised final guideline is expected to be available in a few months.

May 19, 2025 · Prices and Awards

Alzahra Hamdan received the Hans-Günter Schäfer Science Award 2025

The Hans-Günter Schäfer Science Award 2025 goes to Alzahra Hamdan. She is PhD student in her third year of studies in Pharmacometrics at the Uppsala University/Sweden and was awarded for the publication „Longitudinal Analysis of Natural History Progression of Rare and Ultra-Rare Cerebellar Ataxias Using Item Response Theory”. This paper (Clin. Pharm. Ther., doi:10.1002/cpt.3466) highlights the role of natural history studies and innovative methodologies in enhancing trial-readiness for rare diseases.

This award is sponsored by the Frankfurt Foundation Quality of Medicines (FFQM) and endowed with 1,000 €. Alzahra Hamdan received this award on May 16 at the PKPD expert meeting in Bad Dürkheim/Germany, an annual conference organized by the Arbeitsgemeinschaft für angewandte Humanpharmakologie (AGAH).

The certificate was handed over to the awardee by the AGAH president, Dr. Joachim Höchel (Bayer AG/Berlin), the meeting chair Dr. Nele Müller-Plock (Certara/Berlin) and Prof. Henning Blume, chairman of FFQM’s board.

The Foundation congratulates Alzahra Hamdan for impressive research findings and wishes her continued success in further scientific activities.

March 19, 2025 · Prices and Awards

Lifetime Achievement Award for Professor Gordon Amidon

The Frankfurt Foundation Quality of Medicines will present this year’s Lifetime Achievement Award to Prof. Dr. Gordon L. Amidon of the University of Michigan, USA.

The award is in recognition of Professor Amidon’s exceptional achievements in the field of pharmaceutical sciences and his outstanding contributions to improving the quality and efficacy of medicinal products.

The award ceremony will take place during the symposium “Advances in Predictive Biopharmaceutics, Drug Product Quality and Patient Benefit”, which is jointly organized by the Johannes Gutenberg University and the Frankfurt Foundation Quality of Medicines and will take place on 11 July 2025 in Mainz (link to the conference program: https://ak-lang.pharmazie.uni-mainz.de/ffqm-jgu-symposium/

Gordon Amidon’s scientific contributions have improved the understanding of drug absorption and significantly influenced the assessment of generic equivalence through in vitro studies. He was instrumental in the development of the Biopharmaceutical Classification System (BCS) and its implementation as a BCS-based biowaiver concept. Today, the BCS is used worldwide in the development of solid oral dosage forms.

February 19, 2025 · News

Quality of Medicines Award 2025 announced.

The Frankfurt Foundation Quality of Medicines (FFQM) and the German Pharmaceutical Society (DPhG) jointly award the the Quality of Medicines prize 2025 for outstanding scientific achievements in the field of optimizing and ensuring the quality of drugs. We would like to support fundamental investigations into the quality of drugs on the market as well as innovative concepts to improve them.

The DPhG President and the Chairman of the Board of Directors of the FFQM decide on the award based on a recommendation from the Foundation’s Scientific Advisory Board. The award is associated with prize money of €2,000 and will be presented at the DPhG annual conference in 2025 in Freiburg.

Applications can be submitted electronically to the DPhG office (info@dphg.de) or to the Frankfurt Foundation Quality of Medicines (info@frankfurt-foundation.org) until July 15, 2025.

Prof. Dr. Ulrich Jaehde, Präsident der DPhG
Prof. Dr. Henning Blume, Vorstandsvorsitzender der FFQM

December 22, 2024 · News

Congratulations, Julia Gabel

Julia Gabel has successfully completed her doctorate with the PhD thesis on the topic “Investigation of the Quality of Essential Medicines in African Countries and of Medicine Quality Screening Technologies for Use in Low-Resource Settings”. The Frankfurt Foundation Quality of Medicines had supported her doctoral studies with a one-year scholarship. We would like to congratulate Julia Gabel for the “summa cum laude” assessment of her doctoral work.

The PhD thesis was supervised by Prof. Dr. Lutz Heide, Pharmaceutical Institute of the Eberhard Karls University of Tübingen. Prof. Heide’s research program focuses on the problems with counterfeit drugs and the challenges of managing healthcare supply chains in low- and middle-income countries.

Julia Gabel’s PhD thesis investigated various issues, some of which are discussed in more detail below.

Information on the occurrence of substandard or counterfeit/falsified drug products in low- and middle-income countries is often imprecise and contradictory. In cooperation with a church-based pharmaceutical supply organization in Nigeria, the Faith-Based Central Medical Foundation, Julia Gabel investigated the quality of 13 essential drugs from various local sources. An important aim of these investigations was to support the local organization in ensuring the quality of the medications it purchases and supplies to Nigerian healthcare facilities. Particularly alarming results were found for dexamethasone tablets, with around 95% of the 22 samples tested not meeting the quality requirements of the pharmacopoeia. This finding was additionally confirmed by an independent laboratory. As a consequence, the Nigerian Medicines Regulatory Agency immediately ordered the withdrawal of all dexamethasone products objected by Julia Gabel’s tests from the market.