"Registered generic drugs are considered interchangeable with brand-name drugs".

Defense of the PhD thesis of Mrs. Yang Yu, MSc.

Authorised generic drugs are considered interchangeable with brand-name drugs. However, concerns still exist in practice. In this dissertation, the role of individual-subject variation in the drug absorption and the effect of post-marketing drug quality changes were studied for generic and the brand-name drug interchangeability. Generic-generic drug interchangeability was studied in a clinical trial and inter-study comparisons.  In conclusion, interchanges of generic to the brand-name drugs or generic to other generic drugs can be applied in clinical practice without clinical consequences. Current regulation for authorisation of a generic drug in Europe is reasonably strict to ensure the bioequivalence of the generic drug with the brand-name drug.

"The thesis provides rich data and information from a regulatory perspective to other stakeholders, promoting better understanding."

What is the response by Yang Yu?

What challenges do you encounter and what is your motivation?

The discussion about generic drugs takes place between physicians, pharmacists, patients and regulators. Dealing with people with different perspectives is challenging. This is also the limitation of my research: not all aspects of issues or concerns about generic drugs interchangeability can be explained. Generic-generic drug interchangeability had not been studied thoroughly before, and neither generic nor innovator companies are interested in the topic. In light of the responsibilities of drug regulatory authorities, the generic-generic drug interchangeability is considered highly important to be regulated; that was one of the motivations for my thesis. In addition, another goal of my thesis was to find out if there is a need and room for regulators to improve the regulation for generic drugs.

The motivations of my PhD research are to investigate the reported issue of concerns regarding interchangeability of generic drugs, and to find out if there is a need and room for regulators to improve the regulation for generic drugs.

"There is room for improvement in regulation of generic drugs, reassuring generic-generic drug interchangeability."

What do you think is the most exciting aspect of the thesis?

Regulatory science is an applied science. At the MEB the PhD research is always combined with the work of assessing medicines for marketing authorisation. Therefore, it is very exciting to keep thinking about the applicability of the findings in practice while performing the investigation. Stakeholders have different opinions on or angles to consider the generic drugs, it's always exciting to have conversations, listening and understanding each other. My thesis serves for better communications,  and better understanding about the effects of the regulations on generic drug use.

Defense Committee

Aula Maastricht University, Minderbroedersberg 4-6 Maastricht.

Friday 19th of May 2017 at 14.00 hrs.

DEFENSE    COMMITTEE               

MAASTRICHT UNIVERSITY                                                                                

Prof. A. Bast



Maastricht University

Prof. C. Neef


Professor of Clinical Pharmacy;

Maastricht University

Prof. D. Burger


Professor of Clinical Pharmacy;

Radboud University Nijmegen

Dr. M. Maliepaard


Alternate CMDh member, senior clinical assessor;

College ter Beoordeling van Geneesmiddelen,


Prof. A. Bast

Chairman degree committee

Professor of Humane Toxicology;

Maastricht University

Dr. M.H.L. Christiaans
Member of degree committee

Dept. of Internal Medicine;

Maastricht UMC+;

Prof. T. van Gelder 
Member of degree committee

Professor of Clinical Pharmacy;

Erasmus Medisch Centrum Rotterdam

Prof. R.A.A. Mathôt
Member of degree committee

Professor of Clinical Pharmacy;

Academisch Medisch Centrum Amsterdam

Prof. G. Haenen

Professor of Redox Modulation of Pharmacological

& Toxicological Processes;
Maastricht University

Prof. R. Koopmans

Professor of general internal medicine,

esp. education;
Maastricht University

Dr. N. Tampal Director;
Food & Drug Administration, Silver Spring, USA
Yao Liu  
Pieter Glerum  Study on bioequivalence - Poster Pitch by Pieter Glerum

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