The EMEA recently issued a Concept Paper on a proposed review of the current Note for Guidance on the use of NIR in the manufacture and quality assurance of medicinal products.
The Concept Paper, issued by the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) (www.emea.eu.int/pdfs/human/qwp/17369806en.pdf), recognises that at the time the current Guidance was developed in 2001-2 the pharmaceutical use of NIR was restricted to larger companies. The original Note sought to reduce the risk of misuse of the method by inexperienced pharmaceutical companies and also to prevent inappropriate assessments.
Since then the use of NIR has matured and assessors and inspectors are becoming more experienced in the use of the technique. And given the more detailed monograph of the European Pharmacopoeia on NIR, a detailed regulatory guidance is no longer needed.
The CHMP and the CVMP have therefore suggested that the Guideline be revised to take into account technical progress and novel equipment abilities and also to clarify those data that should form part of GMP and those that need to be submitted to the regulatory authorities in product submissions and variations. The revised Guideline should be less prescriptive but at the same time enable assessors and inspectors to judge the merits of proposed uses of the technique.
The drafting process is expected to last about two years including public consultations with an anticipated date of adoption of the revision by Q4 of 2008 and implementation in Q2 of 2009. The first draft for public comment is expected to be available in Q1 of next year.