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EMA and FDA agree how drug firms should include Q8, Q9 and Q10 QbD concepts in applications

By Gareth MacDonald+

20-Apr-2017
Last updated on 20-Apr-2017 at 12:52 GMT2017-04-20T12:52:40Z

iStock/MattiaATH
iStock/MattiaATH

The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.

The regulators announced results of their QbD pilot programme yesterday , explaining that two Marketing Authorisation Applications (MAA)/ New Drug Applications (NDA), three manufacturing variation/supplements and nine applications for scientific QbD advice were jointly assessed.

The agencies said they generally agree on how drug firms should include QbD concepts set out in International Council for Harmonisation (ICH) Q8, Q9 and Q10, basing their conclusion on three Q&A documents co-developed during the pilot.

They cited the joint review of a post approval supplement as evidence of their alignment, explaining they were “harmonized on the expected level of detail in the protocol and considerations for implementation of a risk-based approach to evaluate the changes proposed in the protocol.”

However, the EMA and FDA said the pilot scheme allowed them to harmonize their expectations in areas such as continuous manufacturing, citing batch definition, excipient control and real-team-release testing (RTRT) as topics on which they had reached agreement.

The EMA said: “Overall, it is concluded that, on the basis of the applications submitted for the pilot, there is solid alignment between both Agencies regarding the implementation of multiple ICH Q8, Q9 and Q10 concepts.

The FDA/EMA QbD pilot program opened up a platform for continuous dialogue which may lead to further communication on areas of mutual interest to continue the Agencies’ support for innovation and global development of medicines of high quality for the benefit of patients.”

They added that they are exploring other QbD-focused collaborations in areas such as expedited approval – the EMA’s Prime programme and the FDA’s Breakthrough drug designation – and emerging technologies.

The report comes just a month after the EMA and FDA said they will share active pharmaceutical ingredient (API) and drug manufacturing plant inspection data to allow both agencies to make best use of resources.

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