Regulatory Update – Pharmaceuticals in the Environment

Regulatory Update – Pharmaceuticals in the Environment

The SETAC Pharmaceuticals Interest Group recently presented a session on regulatory practices related to Pharmaceuticals in the Environment (PiE).

Topics included regulation of human pharmaceuticals in the US, Canada, the EU, and Latin America, and global perspectives on veterinary medicinal products.  For a more detailed analysis of the topics discussed, contact us to arrange a call with Smithers Senior Regulatory Scientist, Dr. Erick Nfon.

Overview of session topics:
  • USFDA
    • Regulatory Guidelines (FDA 1998 and EATS) are still applicable
    • Drugs Take Back and Drug Disposal - popular initiatives launched by the FDA
  • Health Canada Initiative
    • Proposal to align environmental risk assessment (ERA) with the safety, efficacy and quality assessment of drugs - aligns with regulatory requirements in Europe and EU
    • Implementation of amendment after 2025
  • EU
    • Technical aspects of ERA as well as the broader EU Policy on PiE
    • Product based rather than active substance assessment – potential pitfalls
    • Revision of EMA Guideline – concept paper on draft Guideline expected end of summer 2021
    • EU Commission reviewing EU Pharma legislation – changes expected in procedure for the pharmaceutical ERA amongst others
  • Veterinary Medicines
    • Regional differences in outcome
    • US (Approval/FONSI/EIS)
    • EU (Approval/mitigation/use restrictions or no approval)
As global regulations on the testing and assessment of human drugs continue to evolve, it is vital to select a CRO with extensive global regulatory knowledge and practical experience. Smithers partners with you by providing a well-defined risk assessment and testing strategy, specific to the unique properties of your product and targeted at the environmental compartments of concern.
Contact us to discuss your needs. 
 
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