Introduction
Since December 1st 2006, guidance has been in place for the environmental risk assessment of human pharmaceuticals (EMEA/CHMP/SWP/4447/00).
European Medicines Agency (EMA) formerly EMEA
An environmental risk assessment (ERA) is required for all new marketing authorisation applications for a medicinal product through a centralised, mutual recognition, decentralised or national procedure. For type II variations, the evaluation of the environmental impact should be made if there is an increase in the environmental exposure. For extension applications according to Annex II of Commission Regulation (EC) No 1085/2003, an environmental risk assessment is also required if there is a potential increase in the environmental exposure.
A tiered approach is used for the ERA. Phase I is a pre-screening stage that provides an estimate of exposure. Phase II is divided into Tiers A and B, Tier A is a screening stage providing an initial prediction of risk. Tier B is an extended risk assessment which provides substance and compartment specific refinement and risk assessment.
Brixham Environmental Laboratory can provide all phases of the risk assessment.
Designing testing strategies
Pharmaceuticals are unique in that the ERA takes place towards the end of a development process that will have already included a great deal of in vitro and in vivo testing of efficacy, safety, metabolism and pharmacokinetics. Brixham Environmental Laboratory has experience of interpreting these data and using them to design an “intelligent” environmental testing strategy.
Study Capability
| STUDY | GUIDELINE |
| Phase 1 | |
| n-Octanol/Water Partition Coefficient | OECD 107 or 117 |
| Phase II Tier A | |
| Adsorption - Desorption Using a Batch Equilibrium Method | One of OECD 106/ OECD 121/OPPTS 835.1110 |
| Ready Biodegradability Test | OECD 301 |
| Aerobic and Anaerobic Transformation in Aquatic Sediment Systems | OECD 308 |
| Algae, Growth Inhibition Test | OECD 201 |
| Daphnia sp. Reproduction Test | OECD 211 |
| Fish, Early Life Stage Toxicity Test | OECD 210 |
| Activated Sludge, Respiration Inhibition Test | OECD 209 |
| Phase II Tier B | |
| Effects on a sediment dwelling organism e.g Chironomus or Lumbriculus | OECD 218, OECD 219 or OECD 225 |
| Effects on micro-organisms e.g Activated Sludge Respiration Inhibition or Pseudomonas putida | OECD 209, ISO 10712:1995 |
| Aerobic and anaerobic transformation in soil | OECD 307 |
| Soil Micro organisms: Nitrogen/Carbon Transformation Test | OECD 216 |
| Terrestrial Plants, Growth Test | OECD 208 |
| Earthworm, Acute Toxicity Tests | OECD 207 |
| Collembola, Reproduction Test | ISO 11267 |
Environmental Risk Assessment
The ERA is presented in Module 1.6 of the submission dossier. Brixham Environmental Laboratory can prepare the ERA, interpreting both the results of the studies and any other relevant data that may be available.
