UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments

According to a report published Monday, trade associations, manufacturers, universities and researchers gave their opinion on the draft strategy of the UK Medicines and Health Products Regulatory Agency (MHRA) for standards development. pharmacological.

In general, the MHRA argues that the value of standardization has been confirmed and that standards could add value, including providing guidance and ensuring consistency of product characterization and quality control, ensuring the performance of standards. analytical methods and facilitate the development of bioanalytical methods.

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In January, the MHRA asked for comment on its strategy as more organic products entered the market and the regulator sought to become "a precursor and precursor of innovative approaches to standardizing biological drugs."

MHRA has established a five-year strategy for biological pharmacological standards, with a first step in comparing its current approach to the development of biological monographs with alternative procedures. The regulator is also planning to identify gaps and weaknesses in its current portfolio of standards and strengthen its understanding of these needs, including strengthening industry linkages and knowledge of how manufacturers control quality. products.

These and other activities will require the MHRA and its regulatory units, the National Institute of Biological Standards and Control and the British Pharmacopoeia, to pool their resources.

Earlier this year, a group of government agencies was established to help implement the strategy, including experts from the MHRA, UK Innovation Office, British Pharmacopoeia and NIBSC.

Consultation Comments

MHRA says: "It was clear that many stakeholders felt that both the type and function of" standards "were essential to ensure they were fit for purpose."

For example, for biotechnologically produced proteins, comments indicated that standards "should not be unnecessarily restrictive and allow the development of new products and technologies over time", while recognizing the specific nature of these concepts standardization products.

For Advanced Therapy Medicine (ATMP), commentators stated, "Due to the emerging nature and complexity of this product category, it is important that the standards developed are not unnecessarily restrictive and do not impede key areas in which standards could add value would be the development of a common understanding and the coherence of testing methodologies. "

The MHRA also noted that for ATMPs, "there was a strong preference for non-mandatory guidance, including standards for specific analytical technologies and techniques supported, as appropriate, by physical standards.

A number of interest groups also suggested exploring two new concepts for complex biological drugs, such as monoclonal antibodies, although MHRA notes that they were previously recommended in an International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) and the European Generics Association (EGA) 2014.

Setting the standards for raw materials has also been "widely recommended," MHRA said. "Control of raw materials was considered important because its properties could influence the critical quality attributes of bulk biological substances."

Looking ahead, the MHRA reports that it will hold a symposium in 2018 on the progress of its work on pharmacopoeia standards and that annual updates will be provided through symposia or online events.