Woodcock: More predictable manufacturing may ease regulations

Drug manufacturing experts from the 1950s would have no trouble recognizing today's manufacturing processes, according to the FDA's Janet Woodcock. But that will change as batch processing gives way to more efficient continuous-process manufacturing.

Woodcock spoke at the 25th annual AAPS meeting in Washington, D.C., on Sunday, as sister publication FiercePharma reports. She took a look 25 years into the future and described what she saw.

The current focus on emerging markets will drive international regulation. "The U.S., EU and Japan will likely become members of a larger group of regulators dedicated to enforcing worldwide standards of drug efficacy and safety," according to the report. She expects international standards harmonization will affect all stages of drug development and commercialization, but especially manufacturing. Regional rivalries would probably develop--as well as varying expectations from country to country--without harmonization, she explained.

Woodcock also believes drug regulation will become "less intrusive and less complex in the next 25 years," according to her report. That's because today's manufacturing regulations are geared toward the uncertainties of batch processes.

"The more we can make those predictable, the less regulation we will need," she said in the report. On the way to achieving that predictability, toxicology and risk prediction will be among the most turbulent sectors in the coming years.

- here's the report


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