MHRA Updates on Biologics Pharmacopoeial Quality Strategy
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday provided an update on its strategy for pharmacopoeial quality standards for biological medicines.The agency's five-year strategy for pharmacopoeial quality standards for biologics was released in 2017 following a public consultation earlier that year.
For its 2019 update, MHRA said it reviewed its strategy and work program and made editorial changes to the strategy document to bring it in line with the its Corporate Plan 2018-2023. The work program remains unchanged from previous versions.
The update does, however, set out steps the agency plans to take over the next year in order to implement the strategy.
Over the next 12 months, MHRA says it will convene its working party on alternative approaches for biotechnologically produced proteins "to develop deeper understanding of performance and class-based concepts" and establish a new working party for advanced therapy medicinal products (ATMPs) to help develop standards that "support quality and innovation" for those products.
"The agency and working party recognize the importance that broader engagement will have on the understanding of performance and class-based concepts and the additional value they may support," MHRA writes.
MHRA also says it will continue its engagement efforts related to pharmacopoeial quality standards by participating in workshops and conferences, maintaining a dialog with industry and other healthcare stakeholders, and providing public updates on the program as necessary.
The agency also says it will continue to participate in bilateral meetings with international regulators and pharmacopoeial bodies to foster international collaboration for pharmacopoeial standards.
MHRA