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EU Extends GMP, GDP Certificates Through 2022

October 5, 2021

EU regulators have extended the expiration dates of good manufacturing practice (GMP) and good distribution practice (GDP) certificates for drugmakers through the end of 2022 to ensure continued supplies of drugs during the pandemic.

In April 2020, the European Commission, the European Medicines Agency and the Heads of Medicines Agencies — a network of the heads of the authorities responsible for the regulation of medicinal products in the European Economic Area — originally extended the certificates through the end of 2021.

The extended certificates are necessary to prevent shortages of starting materials, reagents, intermediates or active substances, the regulators said.

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