News about GMP/cGMP

04.06.2020

EC presents concept for the supply of medicinal products for comment

On 3rd June 2020, the European Commission published a concept for the safe and affordable supply of medicinal products in Europe. 
The initiative Pharmaceutical Strategy - Timely patient access to affordable medicines is designed to facilitate innovation in the pharmaceutical industry. 

The knowledge gained from the COVID 19 pandemic will also be taken into account. The EU plans to minimise the direct dependence on production from non-EU countries. All levels of the supply chain from laboratory development to authorisation and patient access will be covered by the EU's forward-looking strategy for medicines. Adapting the regulatory framework to the rapidly advancing technological and scientific developments remains a challenge. 

The following areas of modern technology are just some of the requirements that need to be addressed to provide patients with timely access to state-of-the-art medicines:  

  • Personalized therapies  
  • Gene Therapies  
  • Medical technologies such as smart health apps  
  • Self-learning artificial intelligence

The document can be commented on from 2 June to 7 July 2020 after registration directly here via the yellow feedback button. It is also interesting and worthwhile to take a look at the comments that have already been received and are publicly visible on the website. After the feedback phase, the document will be available for public consultation. This is planned for the second quarter of 2020, with adoption by the Commission scheduled for the fourth quarter of the year. 


Source:

EC: Pharmaceutical Strategy - Timely patient access to affordable medicines 



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