The Nanomedicines Working Group (NWG) works on the exchange of non-confidential information on nanomedicines and nanomaterial in drug products and borderline and combination products.
1. General considerations and background
Nanomedicines are a rapidly emerging and evolving drug product category with the potential to provide earlier disease detection, improve the precision of diagnosis and improve patient outcomes while potentially reducing adverse reactions and health care costs. This working group uniquely functions to disseminate knowledge in this field between international regulatory agencies thereby improving the community’s understanding and capability to effectively regulate these products. The work of this group will ultimately improve the regulation of nanomedicnes and nano-enabled medical products providing more rapid access to high quality, effective medicines.
The International Regulators Working Group on Nanotechnology was established in summer of 2009 under 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 IPRF 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 Nanomedicines WG to share non-confidential information. EMA agreed to collect comments for a draft mandate and work plan for the new WG.
Objective 1: INFORMATION SHARING and TRAINING
- Non-confidential information sharing, regulatory harmonization or convergence focused on nanomedicines / nanomaterial in drug products, borderline and combination products and follow-on nanomedicnes.
- Discussion and information sharing on novel or emerging nano-enabled technologies.
- Collaboration of training organization between international regulators.
Objective 2: REGULATORY COLLABORATION
- Regulatory cooperation, including work-sharing, in specific areas of nanomedicines / nanomaterial in drug products with other related international bodies.
- Promotion of potential consensus finding on standards.
- 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.
- Rotating chair
- Scientist/experts should be invited upon expertise required and agenda topics
- International regulatory authorities
- 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).
Survey on Liposomes
The NWG is conducting a Survey on Regulatory Requirements and Research Needs for Liposome Products amongst stakeholders, including Regulatory Agencies and other non-Regulatory stakeholders. Answers are invited by 1 September 2020.
Please use the below forms:
In 2016, a survey was conducted among the International Pharmaceutical Regulators Forum (IPRF) Nanomedicine Working Group (NWG) members to map and exchange regulatory requirements for medicines that contain liposomal products (Link for survey results).
In Jan 2018, the IPRF and the International Generic Drug Regulators Programme (IGDRP) were consolidated to establish the International Pharmaceutical Regulators Programme (IPRP). The membership of the IPRP NWG has since expanded and currently there are 12 members and observers represented in the group (Link for IPRP NWG Members and Observers). The focus of IPRP NWG includes non-confidential information sharing, regulatory harmonization or convergence focused on nanomedicines/nanomaterials in drug products, borderline and combination products, and follow-on nanomedicines.
IPRP NWG wishes to extend the survey in order to gain an overview of the regulatory progress that the expanded regulatory membership has made with liposomal products over the past 4 years. A comparative analysis of the regulatory landscape for liposomal products will assist the working group to identify the needs of both research and standard development. The analysis will also enhance the potential for harmonization of regulatory requirements.
In this 2020 survey, some survey questions have been updated, but most remain the same for better comparison of 2016 and 2020 survey responses. In addition, there are two questions for non-regulatory stakeholders regarding regulatory research and standard needs to support liposome product development. These questions have been provided as a separate, shortened survey for non-regulatory stakeholders.