Information Required to Establish Quality

It should be noted that one of the ICH topics (M4) currently under discussion is a common technical document suitable for registration of medicinal products in the EC, USA and Japan. The draft requirements are at an early stage, and any harmonisation of requirements is likely to be an involved procedure given the currently differing regulatory practices in the three participating regions. 

A selection of guidelines issued by the CPMP relevant to Part II of the dossier are listed in Table 2-2. The following sections will describe in more detail some of the information expected in Part II of the dossier, highlighting areas where NMR spectroscopy makes a 

CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL TESTING OF MEDICINAL PRODUCTS 

Immediate packaging material Control tests on intermediate products Control tests on the finished product 

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