Nanos and drugs

The National Agency for the Safety of Medicines and Health Products (ANSM) published a report in 2011 on theBiological evaluation of medical devices containing nanomaterials.

Radio silence then… it took almost ten years to obtain a new report, composed of unfortunately relatively dated information:

• THEarticle 60 of the law on the modernization of our health system had planned for the government to submit a report to Parliament in the summer of 2017 on nanomaterials in medicines and medical devices.
• But whilein July 2018, the Ministry of Health announced its forthcoming publication, mid-2020, we still had no record of this report.
• Despite its numerous reminders to the Ministry of Health, AVICENN had not succeeded in obtaining more information, except that the report, produced by the ANSM, would be finalized and in the process of interministerial validation… since at least December 2017!
• In July 2020, AVICENN therefore sent a registered letter to the Prime Minister and to the Minister of Solidarity and Health to demand the dissemination of the government report on nanomaterials in medicines and medical devices which should have been made public three years ago.
• Le report received on August 3, 2020 presents neither date nor author(s), nor precision on the methodology, and contains mostly old references and important limits.

- In French :

• LNE, Workshop on the theme of nanomedicines and medical devices based on nanomaterials, June 30 2022
• European Directorate for the Quality of Medicines and Healthcare, Quality requirements for nanomedicines: what role for the European Pharmacopoeia?, June 7-8, 2022
• What to choose, Ban on titanium dioxide – European Medicines Agency put the brakes on, Oct. 28 2021
• CNRS Ile de France, GIF on Yvette, Nanomedicines, on a small scale for large applications, June 10 2021
• Daily Geek Show, These medicinal nanoparticles are particularly promising against cancer, January 4 2021
• The Conversation, What happens to gold nanoparticles from drugs in our body?, Florence Gazeau and Florent Carn, March 3, 2020
• the novelist, Environment: drug nanoparticles risk dispersing in natureJanuary 2020
• Galien Institute, Paris-Sud University, Nanos full of bronchial tubes, Video, “Ideas full of Tech”, November 2019
• Academy of Sciences – National Academy of Pharmacy, Nanomedicines: where did we come from and where are we going?, Oct. 16 2019
• NanoResp Forum, Medicines and vaccines: what are their nanoparticles used for?, May 20 2019
• AVICENN, After food, the suspension of titanium dioxide in toothpastes and medicines?,Veillenanos, March 28, 2019
• Saadia Kerdine-Romer, Hervé Hillaireau (Labex LERMIT), Nanoparticles are promising drug carriers, but what about their toxicity, especially on the immune level?, Life Sciences UPSaclay, March 1, 2019
• Arnaud Pallotta and Jordan Beurton, Nanoparticles and drugs, Pint of Science Festival, Target Therapeutics and Formulation Laboratory – CITHÉFOR (University of Lorraine), Nancy, March 27, 2019
• Direct Stock Exchange, Sanofi partners with a Lyon start-up for the production of an innovative nanoparticle in oncology, February 20 2019
• APM news, The ANSM recommends changing the regulations on nanomaterials in health products (report), February 13 2019
• University of Lorraine, Nanoparticles in drugs: how to ensure quality control, The Conversation, December 17, 2018
• CNRS, Nanomaterial delivers drugs under infrared light, Institute of Physics and Chemistry of Materials of Strasbourg (IPCMS, CNRS/University of Strasbourg) and Institute of Chemistry and Processes for Energy, Environment and Health (ICPEES, CNRS/University of Strasbourg), November 26, 2018
• Fiva, Blueberry Therapeutics has raised approximately $12,7 million to develop nano-medicines that treat skin and nail infections, August 2018 (Investors included China Medical Venture Investment and A&B Company, a Hong Kong-based health technology manufacturer)
• Ministry of Solidarity and Health, Risks linked to the presence of titanium dioxide nanoparticles in medicinal products, answer to the written question of Senator François Bonhomme, July 2018
• Poirot-Mazeres I, Drugs in nanoparticle form and medical devices containing nanomaterials: a new deal for the benefit-risk balance, in: Louis Dubouis Days, The new challenges of the pharmaceutical policy of the European Union. For safe, innovative and accessible medicines, Toulouse Capitole University, May 23-24, 2018
• Hello Doctors?, Levothyrox: metal nanoparticles in the new formula?, May 2 2018
• cordis, The delivery of drugs in the form of nanoparticles to combat antibiotic resistance, Cyclon Hit, April 30, 2018
• 60 million consumers, Drugs: nanos in Efferalgan and Nurofen, March 22 2018
• LNE, Nanomaterials and drugs: how to characterize and measure them?, Webinar, February 6, 2018
• What to choose, Nanoparticles – Beware, they are hiding everywhere!, Monthly n° 566, February 2018
• ANSM, Nanomaterials in medicines and medical devices, date ? 2017? (report obtained by AVICENN on August 3, 2020)
• European Parliament and Council of the European Union, European regulation relating to medical devices n° 2017/745, April 5, 2017:
  • The devices are designed and manufactured in such a way as to reduce as far as possible the risks associated with the size and properties of the particles which are, or are likely to be, released into the patient's or user's body, unless they enter in contact only with intact skin. Particular attention is paid to nanomaterials.
  • All devices that incorporate or consist of a nanomaterial fall under:
    • class III if they have a medium or high internal exposure potential,
    • Class IIb if they have a low potential for internal exposure, and
    • Class IIa if they have negligible internal exposure potential.
• UFC What To Choose, Dye E171 Medicines too!, February 4 2017
• AVICENN, What vigilance regarding nanomaterials in drugs and medical devices?,veillenanos.fr, July 2016
• Michele Rivasi, The Commission has no exhaustive list of nanomaterials present in medicines authorized on European soil, September 3 2015
• LNE, Nanoparticles and Medical Devices: How to respond to regulations regarding the characterization of materials?, Webinar, December 11, 2014
• LEEM, Applications of nanotechnology to medicine, February 13 2014
• Afssaps (now ANSM), Recommendations for the toxicological evaluation of medicinal products in nanoparticle formOctober 2011
• Afssaps (now ANSM), Biological evaluation of medical devices containing nanomaterials, Scientific Report, February 2011

- In English :

• The website of the European Nanomedicine Characterization Laboratory (EUCL)
• Orthogonal and complementary measurements of properties of drug products containing nanomaterials, Simon CG et al., Journal of Controlled Release, 354: 120-127, February 2023
• Squalene-based multidrug nanoparticles for improved mitigation of uncontrolled inflammation, Dormont F et al., Science Advances, April 27 2020
• Measuring nanoparticles in medicinal products, EU Science Hub (JRC), 10 May 2019
• Nanopilot : “A Pilot Plant for the Production of Polymer-based Nanopharmaceuticals in Compliance with GMP”
• Nanopharmaceuticals and Drug Delivery: Challenges and Breakthroughs, Dublin, 16-17 August 2018
• Smart nanomaterials for drug delivery: past, present and future, Satapathi S, International Journal of Drug Research and Technology, [Sl], 8(1), February 2018
• Characterization of nanoparticles intended for drug delivery, Scott E. McNeil, Editor. Methods in Molecular Biology. Flight. 1628, Humana Press, New York, NY. ISBN: 978-1-4939-7350-7, 2018
• FDA, “Drug Products, Including Biological Products, that Contain Nanomaterials” – Guidance for Industry – Draft guidance, December 2017 (submitted for consultation until March 2018)
• Nature Nanotechnology, The evolving landscape of drug products containing nanomaterials in the United States, D’Mello SR et al., 2017