Harmonize Innovative Manufacturing Regulation: PhRMA

Responding to an FDA discussion paper on distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that “globally harmonized approaches towards innovative manufacturing regulation will help ensure these advances provide their intended benefits.” The PhRMA comment letter encourages FDA to work with the UK’s Medicines and Healthcare Products Regulatory Agency and with the European Medicines Agency to harmonize definitions, approaches toward quality systems, and other elements raised in the discussion paper. PhRMA also recommends that the agency clarify whether there are any unique considerations for the manufacture of investigational drugs using DM or POC.

The letter also contains the association’s answers to questions FDA raised in the discussion paper.