The Poor Relation in Drug R&D—Chemistry, Manufacturing and Controls

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Managing Consultant at PharmaFlow | Developing Medicines for the 21st Century: Safe, Better, Cheaper

Apr. 29, 2024, 8:00 p.m.

Opinion Article

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So, What is Chemistry, Manufacturing and Controls?

First off, and with apologies to those who already know this, we start with the basics. Drugs are regulated by a designated competent authority known as a Regulatory Authority. In the United States, the Regulatory Authority is the Food & Drug Administration (FDA). In Europe, the Regulatory Authority is the European Medicines Agency (EMA). In Japan, the Regulatory Authority is the Pharmaceuticals and Medical Devices Agency (PDMA).

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