IPRF Nanomedicines Working Group

Mandate

1. General considerations and background

The International Regulators Working Group on Nanotechnology was established in summer of 2009 to discuss nanotechnology related issues relevant to regulated products that may contain nanoscale materials. The U.S. Food and Drug Administration (FDA) hosted the first meeting. Discussions focused on key issues such as the definition of nanotechnology, standards, biocompatibility, risk/safety assessments, and labeling.

The EMA hosted the first International workshop on Nanomedicines in 2009 and chaired since then biannual webinars / teleconferences with the International Working Group on Nanomedicines under confidentiality agreements.

As an emerging product category, nanotechnology-based therapies became a topic for the Regulators Forum in 2014. EMA updated the MC about the already existing International Working Group on Nanomedicines and asked whether IPRF could provide an overall "home" for the topic. It was proposed to have an inclusive Nanomedicines WG within IPRF for the exchange of non-confidential information. The proposal was supported by HC, Japan, ASEAN, Swissmedic, FDA and ANVISA, among others.

Agreement was reached to establish a Nano WG under IPRF to share non-confidential information. EMA agreed to collect comments for a draft mandate and work plan for the new WG.

2. Objectives

  • Non-confidential information sharing, regulatory harmonization or convergence focused on nanomedicines / nanomaterial in drug products and borderline and combination products.
  • Regulatory cooperation, including work-sharing, in specific areas (see work plan) of nanomedicines / nanomaterial in drug products with other related international bodies.
  • Collaboration of training organization between international regulators (see work plan).
  • Promotion of potential consensus finding on standards (see work plan for details)

3. Scope

  • Products to be discussed by this group include nanomedicines / nanomaterial in drug products and borderline and combination products.
  • Methodologies used during the development and evaluation of such products shall be considered as well.

4. Composition

  • Rotating chair
  • Scientist/experts should be invited upon expertise required and agenda topics
  • International regulatory authorities

5. Deliverables

  • 2-3 webinars / teleconferences per annum
  • Using platforms in the regions to disseminate harmonization efforts / outcome (see work plan for details)
  • Share training and workshop organization and enable mutual involvement (see work plan for details).