Regulatory authorities guidelines

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. 

The regulatory authorities in the United States have issued interim guidelines for the interchangeability of blister packaging materials. The initial suggested criterion for consideration is ... 

However, it is nonetheless true to say that the contents of guidelines is advisory and that it is possible in justified cases to deviate from them. But in order to justify deviations it is first necessary to know the current thoughts of the regulatory authorities on a particular topic. How can this be done ... 

Regulatory authorities such as the FDA have prepared guidelines on comparability protocol, Comparability Protocols—Chemistry, Manufacturing and Controls Information, to enable manufacturers to follow a plan to establish and substantiate that changes to postapproval processes do not affect drug quality. 

Some regulatory authorities have foreseen the future impact of TM and set up appropriate guidelines. The European Union has legislation for traditional herbal products. Another example is the Therapeutic Goods Administration of Australia, which has set up a complementary medicine section that controls the regulatory practices for TM. 

There are numerous guidelines which outline the regulatory aspects of HPLC analysis available on the internet. Table 4 represents some of the regulatory authorities and their associated websites. 

An MEKC method for the determination of ibuprofen, codeine phosphate hemihydrate, their nine potential degradation products, and impurities in a commercial tablet formulation was developed, optimized, and fully validated according to ICH guidelines and submitted to the regulatory authorities. The optimized system containing ACN as organic modifier allowed baseline separation of ibuprofen, codeine, and nine related substances within 12 min. 

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