ENVIRONMENT AND MEDICINES: NEW COLLABORATION

REGULATORY CONTEXT

Directive 2001/83 / EC, amended by Directive 2004/27 / EC, requires the environmental impact to be taken into account in the benefit / risk balance for the evaluation of pharmaceutical products for human use.

Thus, for pharmaceutical products for human use, an environmental risk assessment (ERE or ERA) is required (or must be updated):

• for all new applications for Marketing Authorization (MA) of a drug through a centralized procedure, mutual recognition, decentralized or national,
• for any new indication, resulting in an increase in the extent of use, resulting in a foreseeable increase in environmental exposure.

The environmental risk assessment considers emissions from the use, storage and disposal of drugs; the manufacturing step is excluded from this assessment.

our services

ATOUT PHARMA and ROVALTAIN offers you to carry out the environmental risk assessment (ERE / ERA) for the marketing authorization file for your medicine in accordance with the guide of the European Medicines Agency (EMA), namely:

• carrying out the studies required in GLP by ROVALTAIN and monitored by ATOUT PHARMA,
• the drafting of the environmental risk assessment (module 1.6) of the AMM application file in the international standardized format called "CTD" (Common Technical Document).

> ENVIRONMENTAL RISK ASSESSMENT (ERA)

• Draf guideline of November 2018 EMEA / CHMP / SWP / 4447/00 Rev.1

> Phase 1

• Risk Assessment
• Criteria Persistent, Bioaccumulative, Toxic (PBT)
• Evaluation of specific substances (PE, antibiotic)

> Phase 2

• Realization conditional on phase I
• Tier A: PEC / PNEC comparison, based on physicochemical, environmental fate and ecotox studies
• Tier B: refine the PEC and, if justified, other studies are to be carried out

> MONITORING OF EXPERIMENTS

• Good Laboratory Practices (GLP)
• ROVALTAIN partner laboratory

> Formalism

• Drafting of module 1.6 of the MA dossier in the internationally standardized "Common Technical Document" (CTD) format

Monitoring of environmental studies

ATOUT Pharma has set up an exclusive partnership with the only French laboratory accredited by the National Medicines Safety Agency (ANSM), Rovaltain Research Company (RRCo). This French laboratory specializes in studies in physico-chemistry, ecotoxicology and the environmental fate of substances. It performs under GLP (GIPC or ANSM depending on the case) the tests according to the OECD guidelines series 100 (Physico-chemistry), 200 (Ecotoxicology) and 300 (Environmental fate and bioaccumulation) as well as tests according to ISO standards and CIPAC. Committed to high quality science, their latest generation equipment and specialized scientific teams are the guarantee of independent, reliable and high quality results.