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MHRA updates biologic quality guidance document

The UK Medicine and Healthcare products Regulatory Agency has released a revision to its standards for ensuring high quality of biologic products.

The UK Medicine and Healthcare products Regulatory Agency (MHRA) has announced reforms to its strategy to ensure quality standards for biologic products during development and manufacturing. 

It is important that the Agency develops a strategy for pharmacopoeial standards”

The changes are an update from a public consultation, held in 2017, which aimed to provide direction on improving medicine qualities.

The Strategy for Pharmacopoeial Public Quality Standards for Biologic Medicines drafts actions that the agency is planning to take in order to implement its strategy. The MHRA has made editorial alterations to the standards document.  

The MHRA states that: “Biological medicines are set to be of increasing importance in the healthcare landscape over the next five years with a greater number of products and Advanced Therapy Medicinal Products (ATMPs) available as well as representing an increasing proportion of healthcare expenditure. It is important that the Agency develops a strategy for pharmacopoeial standards to ensure it continues to contribute effectively to the assurance of quality.”

The amendments to the advice highlight its plan over the next 12 months to implement its focus on standards development, in collaboration with stakeholders in the industry. It also recognises the importance of quality, innovation and life sciences.

The document was formulated in conjunction with the broader pharmaceutical industry, regulators and pharmacopoeias.

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