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Dossier for New Chemical Entity approval

Issue: May 21, 2015
| Category: API, Regulatory Topics




At Merck, we continuously strive to bring our regulatory expertise to the next level in order to better help you with your approval processes. One example of this is our regulatory documentation for active pharmaceutical ingredients. For many years we have supported our customers by providing and updating information on existing active substances in order to facilitate their approval processes.

Now for the first time, an Active Substance Master File (ASMF) for a new chemical entity (NCE) that has not yet been used as an active ingredient has been submitted to the health authorities. Using our knowledge and expertise, for one customer we helped them fulfill the strict requirements by putting together a dossier which supported their Marketing Authorization Application (MAA). As result, this MAA was approved for EU in February 2015.

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