EMA Recommends Extending GMP Certificates Until End of 2021

The European Medicines Agency (EMA) recommended that good manufacturing practice (GMP) certificates for drugmakers be extended until the end of 2021 to avoid potential drug supply-chain disruptions during the pandemic.

The automatic extensions shouldn’t require any input from companies for sites within the European Economic Area (EEA) — which includes the EU member states, Norway, Iceland and Liechtenstein.

For countries beyond the EEA, certificates should be extended unless the issuing authority takes any action that impacts the validity of the certificates, the agency said.

The EMA also said remote batch certifications should be permitted by certified quality professionals, provided they have access to the necessary documents.

Additionally, quality professionals should be able to use paper-based audits and inspection results from EEA regulators for remotely auditing active substance manufacturers, the EMA said.

Read the updated Q&A guidance here: www.fdanews.com/04-20-20-GuidanceRegulatoryCOVID19.pdf. — James Miessler