Therapeutic products

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, the Swiss Agency for Therapeutic Products, is responsible for authorising and monitoring therapeutic products in Switzerland.

Therapeutic products

Medicine

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.

Medical devices

What is a medical device?

A medical device is an instrument, apparatus, in vitro diagnostic, software or other article or substance that is intended or advertised for medical use, and that does not achieve its principal action by means of a medicinal product. Examples: Blood pressure monitor, ultrasound scanner, hip implant, scalpel, cardiac pacemaker, HIV test, surgical gloves, stent, wound sutures, 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. In contrast to the situation for medicinal products, Switzerland has adopted EU legislation for medical devices in an autonomous conformation. This authorises Swiss medical devices manufacturers or retailers to market CE-marked, conforming devices anywhere in the EU in accordance with the principle of the free movement of goods. Reverse arrangements apply to manufacturers in the EU.

What 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). The risks for nano-medical devices are (provisionally) classed according to the existing risk classification. A detailed Guide to the regulation of medical devices can be found at:

Examples of possible nano-medical devices:

Diamond-coated surgical blades, bone replacement materials with nanocrystals, IVD with lab-on-a-chip (LOC) technology, i.e. in-vitro diagnostics with laboratories scaled down to microchip size, filter as artificial kidney, surface texturing of implants or nanomaterials in hyperthermia therapy to combat cancer.

Are nano-medical devices hazardous to health?

Nanotechnology per se is neither hazardous nor safe. In each individual case, a series of factors play a key role, for example how and in what form the nanomaterials are present, their physicochemical properties and toxicological findings. As yet, no serious incidents attributable to the use of nanotechnology in medical devices have been reported anywhere in the world.

Who is responsible for the safety of nano-medical devices?

According to Art. 4 of the Medical Devices Ordinance and the Essential Requirements of the European Medical Devices Directive, the manufacturer is responsible for safety: "The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons …".

Do existing legal provisions need to be amended?

As our knowledge stands, the current legal provisions are sufficient. Manufacturers are already required to evaluate the possible risks of medical devices as part of their risk assessment and clinical evaluation.

Last modification 13.12.2018

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