The UK’s Medicines and Healthcare products Regulatory Agency has made progress in pushing forward with a regulatory framework that will enable medicines to be manufactured at the point of care (POC) or using modular manufacturing (MM) methods.
MHRA: New UK Point Of Care Legislation Will Remove ‘Regulatory Barriers’ To Innovation
The UK’s “world-first” tailored regulatory framework for point of care manufacturing is set to enter into force this summer.
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Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
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The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
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Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.
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Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
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Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
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The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.