The NHPD has recently posted new Monographs, on October 9th, for consultation for Reservatrol, Blueberry, Pomegranate, N-acetyl-L-cysteine, Citrus Bioflavonoids and Red Wine Extract the NHPD via the NHPD Electronic Subscriber Service (BEEPs) to officially notify stakeholders about this new pre-cleared information (PCI).
At the start of July 2013, the NHPD presented its projected six months of calendar of activities from July 1st to December 31st, 2013 which included release of new pre-cleared information of 11 ingredients. The release of these six monographs under consultation represents steady progress by the NHPD to achieving its aim of having more PCI for stakeholders to utilize and to have all 11 monographs out for consultation by stakeholders by the end of the calendar year. The scheduled pre-cleared information that remains to be released by the NHPD are new PCI for Green Coffee Bean Extract, Black Pepper, Piperine and Athletic Support and an update of PCI for Quercetin. Dicentra will be sure to alert industry when the PCI for these ingredients are made public by the NHPD.
These six new Monographs will be open for a 30-day consultation periods from October 9th-November 7th, 2013. Stakeholders are urged to review these six new Monographs and provide NHPD with feedback. As these Monographs are still under consultation, any input can influence what the version that is ultimately posted on the NHPID. The release of pre-cleared information is very advantageous to industry as it streamlines and expedites the submission process through facilitating faster and more consistent licensing decisions. Dicentra’s staff of regulatory experts can assist you with providing feedback to the NHPD, completing your applications with this new pre-cleared information, and advise when a compendial application is the correct course of action for you.
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