Zdrowie i gospodarka · 14/06/2002

International Conference on Harmonisation; Stability Data Package for Registration in Climatic Zones III and IV; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Q1F Stability Data Package for Registration in Climatic Zones III and IV." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance, an annex to an ICH guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products," defines an approach for broader use of Q1A(R) for territories in climatic zones III and IV.