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New Chemical Entities (NCE)

A New Chemical Entity (NCE) can be defined as "a compound which, previously, hasn't been described in scientific literature".1

Europe

For medicines which do contain New Chemical Entities (new active substances), submissions can be made to the EMA using the Centralised Procedure or alternatively, to an individual Member State (for example, the MHRA) for a Marketing Authorisation. If a company already has an authorisation with another Member State, they can make an application under the Mutual Recognition Procedure.

USA

The FDA defines a new chemical entity2 as "a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Act."  The meaning of "active moiety" being:

"the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance."

The FDA grants exclusivity for New Chemical Entities (NCE).  This exclusivity provides the licence holder of an approved new drug application limited protection from new competition in the marketplace for the innovation represented by its approved drug product.

People involved in the developmental stage of a medicine often don't realise the importance of having regulatory affairs support and advice on hand. To address regulatory strategy at an early stage will ensure that your new product reaches the marketplace in the best timeframe available and minimise the risk of being overtaken by your competitors.

Please refer to our regulatory services for further information or contact us with your specific regulatory compliance requirements.

Source: School of Biological & Chemical Sciences, Queen Mary, University of London
2  Source: www.fda.gov