News about GMP/cGMP

12.11.2021

EC: Mandate for strategic approach on pharmaceuticals and environment

EC: Mandate for strategic approach on pharmaceuticals and environment

The European Commission has tasked its ad-hoc working group (WG) on pharmaceuticals in the environment with drafting a concept paper on the regulatory framework. The WG formed in 2020, is joined by the following Member States: Austria, The Czech Republic, Finland, France, Germany, Ireland, The Netherlands, Slovenia, Spain, Sweden, Poland, Romania, Italy and the European Medicines Agency (EMA).


According to the European Commission, "that concept paper should outline expert views that should be solutions oriented to bring the necessary support in the revision of the EU pharmaceutical legislation (Directive 2001/83/EC) and as considerations on main elements and business processes that may need to be reflected in the regulatory framework on the following aspects:

  • Strengthening the environmental risk assessment requirements and conditions of use for medicines and take stock of the results of research under the innovative medicines initiative.
  • Greener pharmaceuticals with respect to antimicrobial resistance. For this point, the ad-hoc WG should also consult the EMA Good Manufacturing and Distribution Practices (GMDP) Inspectors working group on the aspect relevant to manufacturing of active pharmaceutical ingredients and finished medicinal products and GMDP and reflect their input in the finalised concept paper."

The deadline given for a concept paper is March 2022 with an interim deadline for a mature draft in January 2022.

The mandate for the working group is three years and therefore prolonged until March 2024.


Source:

EC: Mandate on the EU strategic approach on pharmaceuticals in the environment


 

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