The EMA released a draft guideline on the manufacturing and control information the agency expects to see in submissions seeking EU marketing authorizations for new or existing active substances used in medicinal products.
The guideline, which defines an existing active substance as one that has been used in a finished product previously authorized in the EU, does not apply to submissions during the clinical research stages of drug development.
Comments on the draft are due by Jan. 31, 2025 ... [EMA]
