Racemates drug guidelines

The guideline concludes with a note that there is no intention to require further data on established medicinal products which contain a racemic drug unless new evidence emerges concerning the safety or efficacy of one enantiomer. If new claims related to the chiral nature of the active substance are made, then supporting studies on the individual enantiomers will be required. 

In Japan, the Pharmaceutical Affairs Bureau (PAB) within the Ministry of Health and Welfare (MOHW) (see Ref. 20 for a description of its organization and functions) has also not yet issued formal guidelines on the approval of racemic drugs. Indeed, no formal guidelines may be prepared on this issue. As recently discussed by Shindo and Caldwell (21),... 

The guideline on chiral active substances states that particular attention should be paid to identity and stereochemical purity. It states that specifications for a racemate should include a test to show that the substance is indeed a racemate and this is a position supported by the requirements of the European Pharmacopoeia for drug substance monographs [16]. 

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

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