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Switzerland, US in agreement on pharma GMP

Switzerland, US in agreement on pharma GMP

A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) was recently signed between Switzerland and the US.

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

The FDA’s Office of Global Policy and Strategy has been negotiating the US-Switzerland MRA for several years. Before the MRA enters into force, Swissmedic must determine whether the FDA is capable of conducting inspections that meet Swiss requirements. The FDA must make a similar determination concerning Swissmedic meeting US requirements.

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GMP MRA
More news about: quality / gmp | Published by Sudeep Soparkar | January - 19 - 2023 | 483

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