Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility

18.05.2020
Are you aware that a few measures were introduced to ensure the supply chain during COVID-19 pandemic? This enables the MAH to act quickly and provides regulatory relief. Here are a few examples:

  • Fast Implementation of Changes
    • Changes for crucial medicines for treatment of COVID-19 patients can be implemented using an exceptional change management process (ECMP). This means that for these medicines, the MAH may exceptionally use alternative suppliers of starting materials, reagents, intermediates or active substances as well as manufacturing and control sites which are not mentioned in the dossier (MAA) in order to mitigate shortages of supplies in the EU.
    • The MAH informs the Authority within 48 h after implementation of the change and commits to submit the variation within 6 months after implementation. Please consider that the MAH is responsible to ensure the quality of the API and finished product from these alternative sources.
    • However, for changes of control tests, the MAH is invited to contact the Authorities and present the adapted control scheme (risk-adapted). Then this should be submitted as variation and marked accordingly ("concerns COVID-19”) to get prompt assessment.

  • GMP-Certificates and Authorisations
    • GMP certificates and time-limited manufacturing and import authorisations are automatically extended until the end of 2021.
    • For new sites there will be a distant assessment, followed by an on-site assessment later.
    • Once COVID-19 restrictions are lifted, there will be again pre-approval and routine inspections (risk-based-approach).

  • QP-Release
    • Remote batch certification (e.g. from home-office) is possible, if the QP has access to all the necessary information.
    • Remote audits of API-manufacturers can be done as long as sufficient information is available to ensure quality, efficacy and safety of the drug product.
    • Batch release of IMPs (Investigational Medicinal Products) from 3rd countries is possible without on-site inspection after review of the relevant documents.

  • Deadlines for Renewals
    • If the MAH has difficulties in meeting these deadlines due to COVID-19 pandemic, the MAH can contact the corresponding authority or EMA with a justified request to postpone the submission deadline.

  • Sunset Clause
    • If you have not placed your product on the market within 3 years after having received the marketing authorisation, the authorisation will cease to be valid. However, now during this pandemic, you might request an exemption based on exceptional circumstances and on public health grounds.

  • Product Information and Labelling
    • To ensure availability of medicines there are regulatory flexibilities, i.e. exemptions in severe cases, such as no translation of product information into the official language of the relevant country or use of different presentations.



There are many more examples. You will find further information here:


Would you like to know more or do you need specific support for your development?

Then, contact us at info@horn-pharma.de.

We know the details and guide you through the process.




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