EMA: GMDP IWG Extends Certificates Validity for Inspections of Pharmaceutical Factories & Wholesalers (end of 2024)

On 7th December 2023, the European Medicines Agency (EMA) updated the regulatory expectations and GMP certificates following the Covid-19 public health emergency current status.

As informed globally by the World Health Organization (WHO), the status of Covid-19 public health emergency ceased in May 2023, hence the GMP/GDP Inspectors Working Group (GMDP IWG) decided to continue carrying out inspections on pharmaceutical factories and wholesalers that have been postponed due to the pandemic.

Previously, the EMA, European Commission, and Heads of Medicines Agencies (HMA) released regulatory flexibility for medicines as a preventive initiative for regulatory and supply challenges due to the pandemic. To continue with the supervision, GMDP IWG decided to continue the validity of the GMP/GDP certificates until end of 2024.

Inspectors will perform the risk-based supervision of sites, either on-site inspection or distant assessment. The inspections will be scrutinized based on risk priorities: sterile product manufacturers, biological product manufacturers, and wholesale distributors of pharmaceutical products. The inspectors may also be depending on the date of the last inspection. The authorities can take action on any serious non-compliance issue found during the inspection.

The validity outcome of the GMP/GDP certificates, either can be issued continuously, have to withdraw from the current certificates, or remain restricted on the GMP/GDP certificates, should be addressed to the authorities that issued the certificates.

Source: European Medicines Agency (EMA)

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