Nanotechnology also has an impact on the development of therapeutic products.
In Switzerland, the term "therapeutic products" refers to the medicinal products and medical devices product groups. The Therapeutic Products Act (TPA) legally governs therapeutic products. Swissmedic is the central Swiss supervisory authority for therapeutic products.
What is a nanomedicine?
No internationally harmonized definition currently exists for this term. Swissmedic regards any preparation that contains nanomaterials – i.e. particles measuring less than 100 nm in at least one of their three dimensions – as a nanomedicine. However, nanomaterials can also form larger structures. Structures of this type measuring up to 1 micrometre in size can also be classed as nanomaterials if they still display typical features of nanomaterials. Active substances and excipients can both be present in the form of nanomaterials.
What is the difference between a nanomedicine and a conventional medicinal product?
A nanomedicine contains nanomaterials. Nanomaterials possess special properties by virtue of their size: 1. Because they are very small, they have a large surface area relative to their volume. This can result in special physical, chemical or biological reactivities. 2. Their small size enables them to penetrate cells with ease and overcome barriers in the body (particularly airways, but also skin, mucous membranes and the digestive tract). This tissue penetration occurs either through passive physicochemical processes or through active cell processes, although both mechanisms can also exist in a certain type of nanomaterials. 3. Of course, the way in which nanomaterials are assembled depends primarily on the desired effect of the medicine.
Why are nanomedicines produced?
"Traditional" medicines are usually distributed throughout the body, i.e. not just in the organ or tissue to be treated. As a result, some of the active substance is lost and side effects occur in healthy cells and tissues. Nanomedicines can reach certain cells with greater accuracy. This is the case, for example, with liposomes or "nanocapsules", which contain an active substance and specifically detect cancer cells. Their higher specificity means that lower doses can be used, which markedly reduces side effects since the medicine barely interacts at all with the healthy cells.
Do special guidelines apply to nanomedicines?
No. The same provisions apply to all medicines. Anyone who intends to apply for authorisation is responsible for all aspects of the medicinal product and must prove that it is of high quality, effective and safe. This involves defining the physical, chemical, biological and analytical aspects of the preparation, and conducting and justifying studies with animals and humans. The applicant also needs to demonstrate that the relevant legal requirements are observed and that the methods used are meaningful. Environmental compatibility tests are also required for new active substances. Swissmedic reviews the documentation that is submitted based on the current state of knowledge. The special properties of nanomedicines can be investigated in conventional studies, for example by conducting animal studies to examine the distribution of the medicinal product in the body. However, new standards applicable to preclinical (with cells or animals) and clinical trials should be expected to emerge in future.
Are nanomedicines already authorised in Switzerland or other countries?
Yes, for example iron preparations for injection, contrast media for magnetic resonance imaging or cancer drugs in liposomes.
What is a medical device?
Medical devices are instruments, apparatus, devices, in vitro diagnostics, software, implants, reagents, materials or other articles or substances that are intended or advertised for medical use, and that do not achieve their principal action by means of a medicinal product. Examples: blood pressure monitor, ultrasound scanner, hip implant, scalpel, cardiac pacemaker, HIV test, surgical gloves, stent, surgical suture material and bone saws.
Do the legal regulations governing medicinal products also apply to (nano-) medical devices?
Medicinal products and medical devices are therapeutic products. The procedures for dealing with therapeutic products are set out in the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA). The specific legal provisions relating to medical devices are contained in the Medical Devices Ordinance (MedDO) and in the Ordinance on Clinical Trials with Medical Devices (ClinO-MD). In contrast to the
situation with medicinal products, Switzerland is orienting itself comprehensively towards the European directives on medical devices and is implementing them in Swiss law.
Which legal provisions apply to (nano-) medical devices?
Regardless of whether the medical device contains nanomaterials or was manufactured/treated using nanotechnology, it must comply with the Therapeutic Products Act and the Medical Devices Ordinance. Classic medical devices are subdivided into four risk classes depending on their hazard potential during use: I (low risk), IIa and IIb (medium risk) and III (high risk). Medical devices containing or consisting of nanomaterials are assigned to risk classes IIa, IIb or III with increasing potential for exposure in the body. Further information on medical device regulation can be found on the Swissmedic website:
Examples of possible nano-medical devices:
Surgical instruments with nanostructures to improve cutting behaviour and wear resistance, bone replacement materials with nanocrystals as well as joint prostheses with nanocrystal coatings for faster integration into the bone, or wound treatment products with nanosized silver particles for improved antibacterial efficacy.
Are nano-medical devices hazardous to health?
Nanotechnology is fundamentally neither dangerous nor harmless. In each individual case, a number of aspects play an essential role, such as the size and composition of the nanomaterials, their physical, chemical and biological properties as well as the exact type and duration of contact with the body.
Who is responsible for the safety of nano-medical devices?
According to the Essential Safety and Performance Requirements according to Art. 6 MedDO as well as Annex I, No. 10.6. of the EU regulation on medical devices (MDR), the manufacturer is responsible for safety: "Unless they come into contact only with intact skin, devices shall be 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 that may penetrate or enter the patient's or user's body. Particular attention must be paid to nanomaterials."
Do existing legal provisions need to be amended?
The current legal provisions are appropriate for the current state of knowledge. Manufacturers must evaluate the potential hazards of a medical device as part of a risk assessment and a clinical evaluation, and must pay particular attention when using nanomaterials.
Last modification 22.07.2021