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Safety Assessment
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Masamichi Kaminishi, PhD, and Daphne F. de Roode, PhD

Pharmaceuticals in the Environment

The necessity of harmonizing EU guidelines in developing a Japanese ERA Scheme on pharmaceuticals

Five years ago, the Ministry of Health, Labour and Welfare (MHLW) in Japan released the Guidance for Environmental Risk Assessment (ERA) on New Pharmaceuticals (1). This MHLW Guidance is regarded an official document for assessment of adverse effects against the environment in Japan that are caused by marketed pharmaceuticals. These substances are used to treat and cure diseases, but following intake by the patient, they are cleared from the human body. After excretion and disposal to wastewater, pharmaceuticals reach the environment, where they may have unintended effects on plants and animals.

However, the assessment procedures stated in the MHLW guidance are confined to a fundamental concept, and the guidelines or guidance documents currently adopted in EU and US should be referred to for detailed step-wise assessment.    

In November 2018, the European Medicines Agency (EMA) drafted a new EU Guideline on the ERA of Medicinal Products for Human Use2). The step-wise assessment as outlined in the current EU Guideline released in 20063) has been maintained but some modifications have been made with respect to the assessment of persistence, bioaccumulation, and toxicity, as well as to the testing strategy in the sediment, terrestrial, and groundwater compartments. Furthermore, a tailored assessment is indicated for active substances with a specific mode of action such as antibiotics and endocrine active substances. The public consultation ended in June 2019, but the final version of the new EU Guideline is yet to be published. 

The new EU Guideline will be a milestone for development of the ERA scheme that suits environmental conditions in Japan. Yet given the current “data gap” in the MHLW Guidance, development of a Japanese ERA scheme harmonized with the EU approach should be further discussed.

References:

  1. Ministry of Health, Labour & Welfare (MHLW), 2016. Guidance on the Environmental Risk Assessment in New Drug Development. Available from: https://www.pmda.go.jp/files/000214195.pdf.
  2. European Medicines Agency (EMA), Committee for medical products for human use, 2018. Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (Draft). Doc. Ref. EMEA/CHMP/SWP/4447/00 Rev. 1
  3. European Medicines Agency (EMA), Committee for medical products for human use, 2006. Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. Doc. Ref. EMEA/CHMP/SWP/4447/00

For further details:

Kaminishi M, de Roode D, et al. Comparison of Environmental Risk Assessment Scheme on Pharmaceuticals between EU and Japan. JSOT Annual Meeting in 2019; Poster; P-174

https://www.criver.com/sites/default/files/resource-files/sa-jsot-comparison-of-environmental-risk-assessment-scheme.pdf 

Kaminishi M, de Roode D, et al. Influence of A New EU Guideline on Environmental Risk Assessment of Pharmaceuticals in Japan. JSOT Annual Meeting in 2020; Poster; P-246

https://criver.widen.net/s/dkcgzwhpp2