EMA publishes a draft Q&A document for consultation on the environmental risk assessment guidelines

On 26 March 2015, the European Medicines Agency ("EMA") published a draft Questions and Answers Document ("Q&A Document") for consultation concerning the EMA's Guideline on the environmental risk assessment of medicinal products for human use ("EMA Guideline"). The purpose of the Q&A Document is to clarify and harmonise the use of the EMA Guideline. The draft Q&A Document, if adopted, will revise the current Q&A document that was adopted on 17 March 2011. The Q&A Document is open for consultation until 30 June 2016. Interested stakeholders can submit their comments to the Q&A Document to the following address: swp-h@ema.europa.eu. Below are some examples of the proposed clarifications in the Q&A Document.

  • Question 1: When do I have to submit an environmental risk assessment 60 (ERA) as part of my initial application for a marketing authorization?
The Q&A Document clarified that justification of the absence of any significant increase in environmental exposure can be demonstrated by suitable information such as consumption data concerning the active ingredient in kg/year. This consumption data must concern, at least, the last four years and represent consumption in various EU Member States.
  • Question 4: The Guideline states that “The Applicant may use the default 100 value or refine the Fpen by providing reasonably justified market data, e.g. 101 based on published epidemiological data”. How may the Fpen be refined in 102 Phase I and what supporting data should be provided?
The draft response to this question clarifies a number of elements, including:
  1. Realistic worse case exposure scenarios based on the default values for wastewater per inhabitant and per day and the dilution factor.
  2. Prevalence data can be used in the environmental risk assessment provided they are of good quality, duly justified and not older than five years.
  3. Justification of the use of other than “1 year-prevalence” data.
  • Question 9: Aerobic and anaerobic transformation in aquatic sediment 197 systems (OECD 308
The draft response elaborates on the type of results that should be reported for the OECD 308 test. These include:
  1. the amount of compound (including Non –Extractable 209 Residues = NER) that has shifted to sediment at any time point at or after 14 days. If this amount is more 210 than 10%, a sediment toxicity test would be required;
  2. half-life values in water, sediment and total 211 system;
  3. kinetic model, chi2 error level of fitting (%), comparison of different models if necessary 212 (4) the identity and amount of metabolites formed;
  4. the amount of CO2 evolution;
  5. the amount 213 of NER formed; and
  6. a total mass balance, including distribution in the test system at any time point 214 and bound (non-extractable) residues.
  • Question 10: Adsorption/desorption
The revised response concerns the preferred study to determine absorption/desorption and the soil adsorption data required for the initial calculation of the soil compartment.
  • Question 12: Which chronic study should be performed for potential sexual endocrine disrupting compounds?
The Q&A Document clarified that evaluation of a potential endocrine effect on the environment is only necessary if the mechanism of action could affect reproduction such as adverse effects in reproductive toxicity studies and/or in the reproductive organs in the mammalian repeat-dose toxicity studies. The Q&A Document also revises the guidance on testing metabolites and assessment of sediment in Question's 15 and 16 respectively.

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