This group focuses on regulatory sciences in the field of bioequivalence, in-vitro dissolution, biosimilars and quality in different regions. If applicable, the group will strive for harmonisation of requirements. Education in new analytical technologies is also within our scope, and we will consider interest and relevance to practitioners in various settings.
The SIG evaluates regulatory guidance prepared by various agencies and provides sponsors of new drug products with the science-based information they need to apply for a marketing authorisation.
The regulatory sciences encompass a wide scope of activities, ranging from laboratory work to support drug product quality through pharmacokinetics and pharmacodynamics to post-marketing surveillance.
In the future, this special interest group will also consider aspects, such as medical devices, digital technologies, nanomedicines, and other innovative trends looking into integrated health care. For these innovative trends new analytical technologies have to be applied. Powerful analytical tools are also required to combat substandard and falsified medicines.
How we work
The special interest group is chaired by Dr Horst-Dieter Friedel (Germany).
Seven focus groups have been set up on specific areas:
- Analytical Sciences, chaired by Prof. Masaru Kato (Japan).
It provides support and education in the application of new analytical methodologies, esp. in separation science, spectroscopy analysis and surface analysis.
- Quality control and QbD.
- Dissolution/in vitro-drug release, chaired by Dr Horst-Dieter Friedel (Germany).
This focus group published the FIP Guidelines for Dissolution Testing for Solid Oral Products in 2018. It also published a report on Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms and the position paper on Qualification of Paddle and Basket Dissolution Apparatus. It organized workshops on Biorelevant dissolution testing in the United States and Europe, and on nanomedicines. Their “Hands-on-Dissolution” workshops in developing countries to improve the drug product quality have been very successful outreach activities of FIP.
- Bioclassification/Biowaiver, chaired by Jenny Dressman (Germany).
It provides a global, independent platform for scientific discussion among academia, industry and regulators on the possibilities and the limitations of biowaivers for in vivo bioequivalence studies. It stimulates optimization of biowaiver methods, contributes to harmonization of the application of BCS based biowaivers and provides leadership in educating scientists worldwide about the BCS Biowaiver and how it fits into the determination of Bioequivalence.
This focus group reviews and publishes biowaiver monographs, reviews and comments on draft guidelines which impact BCS-based biowaivers. Most recently, the Focus group participated in the drafting of the ICH guidance on BCS-based biowaivers (M9) by providing comments on the draft guidance. This document was published in November 2019. For 2020, this focus group is planning a workshop in South America to present and discuss the ICH M9 document.
- Bioavailability/Bioequivalence, chaired by Shinji Yamashita (Japan)
This focus group aims to offer up-to-date information on BA/BE of oral drugs and to discuss the international harmonization in regulating and controlling the quality of oral drug products. Their goals: Understanding not only up-to-date science and technology relating to oral BA of drugs for contributing to the development of effective and safe oral drug products; but also the current status of regulatory issues for oral drug products and proposing international standards.
- Clinical bridging studies, chaired by Oliver Hu (China Taiwan).
It conducts international workshops to harmonize the regulatory requirements for international drug approval process. Among its goals: planning to initiate a discussion on harmonization of bridging studies; understanding the current situation of bridging studies and evaluate 10 years of the E5 guidelines and identify the framework by which drug regulatory agencies could possibly harmonize the need for and interpretation of foreign clinical data.
Annual reportThe 2021 annual report of the SIG on Regulatory Sciences and Quality can be found here.
For more information about this group or to get involved, email RegSciencesQuality@fip.org