Abstract
The need for routine testing of future medicinal products for toxicity to reproduction and development became obvious through the thalidomide disaster. New legal requirements were created, leading to introduction of different testing schemes all over the world. When attempting to fulfil requirements worldwide, somewhat nonsensical piling up of test packages occurred with undue duplication wasting animals.
The ICH topic of reproductive toxicity testing benefited from an already well-oiled machinery of networked experts spanning all ICH parties. Scientifically sound and supported by the six-pack, a draft guideline was presented and accepted, calling for a most probable option with three tests focusing on early embryonic development, organogenesis and postnatal development. An apparent dent, how to best accommodate male fertility testing, was also resolved scientifically and agreed by ICH 2.
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- 1.
It has to be pointed out that during these years, medicines in Germany were not authorised, but registered, meaning a rather passive role for the drug regulatory authority: registration of documents received.
- 2.
Rolf Bass had the pleasure to serve on the Safety Working Party of the CPMP as member for Germany during the finalisation of the guidelines. Later on, as Chairman of the Working Party, Rolf Bass took on responsibility for the further development and international positioning of these guidelines.
- 3.
Rolf Bass had the pleasure to first work with John Griffin and then to take over full responsibility for non-clinical testing during the discussions between the European Commission and the USA and Japan. The European delegation, led by Fermand Sauer from the European Commission, included Anthony Cartright (from the UK authority) who addressed pharmaceutical quality; Jean-Michel Alexandre (from the French authority), who addressed efficacy; and Rolf Bass (from the German authority) addressing preclinical safety. As we remember, these bilateral discussions made obvious the need for international harmonization of non-clinical testing requirements to be fulfilled for obtaining marketing authorization.
- 4.
Together with Beate Ulbrich, Rolf Bass had the pleasure to represent the Drug Institute of the BGA on this ad hoc working group. The outcome, prior to its publication, was used to initiate discussions with the USA and Japan (see above), where the intention was to start harmonization of reproductive toxicity testing mainly for medicinal products. Rolf Bass was in contact with and travelled to the US-FDA and the US Pharmaceuticals manufacturers association (then PhRMA), and the Japanese Ministry of Health (in charge of handling medicinal products)—here the late Professor Yoshihito Omori (Omori 1991) must be mentioned for his openness and scientific strictness towards the regulation of medicines and their toxicological testing as well as for his personal kindness towards the newcomer to Japanese culture—and the Japanese Pharmaceutical Manufacturers Association (JPMA). The very positive outcomes from these discussions helped me to take the next step: discussion with the European Teratology Society. This quickly led to approaching the International Federation of Teratology Societies (IFTS), where a Committee on International Regulation was designated to interact with the recent European developments. On occasion of the IFTS meeting in Sidney, Christmas 1990, where all interested parties were present, Rolf Bass presented the current development. IFTS welcomed the harmonization approach (see publication by Christian 1992). Already in the preparation for ICH 1, the topic of reproductive toxicity testing was tabled, where Rolf Bass became the lead for the topic Safety 5—Reproductive Toxicity Testing. In November 1991, at ICH 1 in Brussels, the draft guideline was presented at step 3 of the ICH process (for further details, see below).
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Bass, R., Ohno, Y., Ulbrich, B. (2013). Why and How Did Reproduction Toxicity Testing Make Its Early Entry into and Rapid Success in ICH?. In: van der Laan, J., DeGeorge, J. (eds) Global Approach in Safety Testing. AAPS Advances in the Pharmaceutical Sciences Series, vol 5. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-5950-7_9
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