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

 

For medicines which do contain New Chemical Entities (new active substances), submissions can be made to the EMEA using the Centralised Procedure or alternatively, to 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.

 

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 this 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.