News about GMP/cGMP

18.06.2021

EMA: Annual Report 2020 published

EMA: Annual Report 2020 published

As every year, the EMA now publishes its report for 2020, in which it outlines achievements, decisions and objectives of the year.


A major topic in this report is the fight against the COVID-19 pandemic. This particular situation required rapid action on drug development, approval and monitoring, especially for COVID-19 vaccines and therapies. Emer Cooke, who has led the EMA as executive director since November 2020, emphasizes that this has never compromised the high standards of safety, quality, and efficacy. To that end, among other things, the EMA pandemic Task Force (COVID-ETF) and ongoing reviews were established to enable rapid decision-making and expedite approval of needed medicines. Furthermore, measures to mitigate or prevent drug shortages have been decided and implemented. In addition, due to the pandemic, there has been a decline in EMA GMP inspections, with only one-third as many conducted in 2020 as in 2019. In 2020, the EU/EEA authorities issued a total of 1843 GMP certificates to manufacturing sites around the world and only one GMP Non-Compliance Statement (for an EU site!).

Other EMA milestones in 2020 were:  

  • Conducting an independent audit of the future clinical trials information system. The system is expected to go live at the same time as the new EU clinical trials regulation in early 2022.  
  • Progress in implementing the new veterinary regulation
  • Recommendation for approval of 97 new human medicines - the highest number in more than 10 years  
  • Approval of 20 veterinary medicines; continued emphasis on fighting antimicrobial resistance  
  • Publication of an annual report on the sales of veterinary antibiotics
  • Publication of updated scientific advice on the categorization of antibiotics used in humans and animals  
  • Preparation for the new EU veterinary medicines legislation  
  • With appropriate preparation by EMA and the EU Medicines Regulatory Network, there were no problems after Brexit came into effect. 

Source: 

EMA: Annual Report 2020


 

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