Patients and Users

Medicinal products and medical devices: from development to market surveillance

The life cycle of a medicinal product

The process from the development of a medicinal product to its market authorisation is a lengthy one.
On average, it takes between ten to twelve years from the first laboratory studies until the first time a product is prescribed.


Swissmedic, the Swiss Agency for Therapeutic Products, is involved in the entire life cycle of a medicinal products because of its mandated areas of responsibility in the sectors of licensing and the authorisation and monitoring of medicinal products.


Background information on the Agency and the areas covered by its mandate can be found at the following link:

Companies must obtain Swissmedic's approval for the clinical trials that will be necessary in order to develop a medicinal product. In addition, a Swissmedic establishment licence is needed in order to manufacture medicinal products. Once the clinical trials are completed, the company may apply to Swissmedic for the product to be authorised. The documentation submitted is assessed by Swissmedic in accordance with the internationally recognised criteria of quality, safety and efficacy. The authorisation is only granted if the level of quality and safety are proved to be high and if the risk-benefit balance is positive. The company receives the approval of the information on the product intended for healthcare professionals and patients (the packaging insert) at the same time as the authorisation.
The pharmaceutical firm may only place its medicinal product on the market once it has received the official authorisation decision.
Switzerland continues to monitor the safety and the quality of the medicinal product even after it has been authorised. To do so, the agency evaluates reports on side effects that are received from Switzerland and also monitors international data. It then takes the necessary decisions in order to minimise possible risks for patients. Swissmedic also intervenes in the case of quality problems, ensuring that defective products are withdrawn from the market.


Swissmedic's areas of responsibility are closely related to those of other authorities or implementing bodies. For the control of retail trade, for example, i.e. of the Cantonal dispensing services for druggists or pharmacies, etc. the responsibility is that of the Cantons.
There are other interfaces such as those relating to questions of delimitation between medicinal products and cosmetics (Federal Office of Public Health, FOPH) or between medicinal products and foods (Federal Food Safety and Veterinary Office, FSVO) office. In order to clarify questions in the case that the delimitation is not clear, Swissmedic takes part in working groups involving specialised professionals from the Federal bodies concerned..

Further information regarding questions on delimitation can be found at the following link:

 

Medicinal products may only be distributed in Switzerland if they are authorised by Swissmedic. To obtain an authorisation for a medicinal product, the applicant must submit documentation proving its efficacy, safety and quality. Under certain conditions, authorisation is not mandatory: the exceptions are stated in Art. 9 of the Therapeutic Products Act (TPA). The requirements with regard to the authorisation documentation to be submitted are specified in the Ordinances on Therapeutic Products and are explained in further detail by means of internationally harmonised directives and instructions that reflect the latest status of science and technology.


Swissmedic's task is to assess whether the documentation submitted constitutes proof of the efficacy, safety and quality of the medicinal product.
If the medical benefit of a product outweighs the related risks, an authorisation is granted.


In principle, a distinction can be made between medicinal products with new active pharmaceutical ingredients1 and those with known active pharmaceutical ingredients.


Please use the following link to find a current overview of Medicinal products with new active pharmaceutical ingredients1:

 

An overview of all human and veterinary medicinal products with the exception of authorised homeopathic and anthroposophic medicinal products without indication (see under Complementary and Herbal medicines) can be found here:

One component of the authorisation by Swissmedic is the so-called "medicinal product information", which consists of the "information for healthcare professionals" and the "patient information": it contains all the important information for the safe use of the medicinal product.


You may use our medicinal product information platform (AIPS) to find information for healthcare professionals and for patients on all human medicinal products that are authorised in Switzerland:

 

If an authorisation is granted, it is initially valid for five years or, in certain cases, for one year only. Once this period expires, Swissmedic examines whether the medical benefit is still greater than the possible risks, e.g. with regard to the side-effects.

 


1 A "new active pharmaceutical ingredient" is one that is has not been contained to date in any other medicinal product authorised in Switzerland.

Medicinal products for rare diseases are called "orphan drugs". They are used to treat rare diseases that are life-threatening or serious, and for which to date, no treatment options or no satisfactory ones are available. The term "rare disease" is used when at most 5 out of 10,000 individuals in Switzerland are affected. The same definition is used in the European Union (EU).

A company may apply for so-called "orphan drug status" as early as during the development phase. The qualification / status as an orphan drug implies major cost reductions in the future authorisation process (no fee for the procedure).
A product with orphan drug status is nevertheless not available for use until it has been granted authorisation as a medicinal product for rare diseases, i.e. the recognition of the status alone is not sufficient.

Swissmedic publishes a list of medicinal products and the corresponding indications for which it recognises orphan drug status. This information can be found in the list, under the column "Orphan drug status granted for the following indication(s)".
If an authorisation as an orphan drug has been granted, you can find the authorised orphan drug indication(s) in the column "Authorised field of application". The corresponding information is then expanded upon in the columns "Authorisation number" and "Date of first authorisation".

Humanarzneimittel
Orphan Drug
(31.08.2017, 286 KB, XLSX)

As soon as the medicinal product to treat rare diseases is authorised, the corresponding patient information is published on the medicinal product information platform AIPS.

The term complementary medicinal products encompasses all homeopathic, anthroposophic and traditional Asian medicines (e.g. medicinal products from traditional Chinese medicine, TCM).
Homeopathic and anthroposophic medicinal products are defined by the type and manner of their manufacturing and the regulations for their use.
The decisive fact with regard to Asian medicines is not their manufacturing but the type of composition of herbal, mineral or animal components, in accordance with specific rules for the type of medicine concerned.
For all three types of medicinal product, a common factor is that they are used for individual therapies, i.e. they are based on a specific treatment concept.

The assessment of these types of medicinal product can be restricted to their high quality and the essential information with regard to safety, while the responsibility for the choice of the correct medicinal product, the correct dose and thus the safe use is that of the doctor or therapist who is trained in the therapeutic approach concerned.

Herbal medicinal products contain only herbal active substances or their preparations, such as chamomile or valerian.

Based on the Ordinance of the Swiss Agency for Therapeutic Products of 22 June 2006 (Complementary and herbal medicinal products ordinance, KPAV), simplified authorisation is possible for complementary and herbal medicinal products. The requirements depend on the risks related to the corresponding products.

An overview of all authorised homeopathic and anthroposophic medicinal products without indication (i.e. without a specified area of use) can be found here:

Herbal medicinal products authorised by Swissmedic can be found in the list of authorised human and veterinary medicinal products.

So-called medical devices are included within therapeutic products, in addition to medicinal products. Medical devices encompass an extremely large range of products. This includes, for example, implants such as artificial hips and heart pacemakers, technical apparatus such as radiology equipment, but also products for the general public such as contact lenses, fever thermometers or devices to measure blood pressure. Medical devices also include in-vitro diagnostic devices such as blood glucose, pregnancy or HIV test kits.
Unlike medicinal products, medical devices do not undergo an official authorisation procedure. For such products, Switzerland applies the system of conformity assessment or certification, based on bilateral contracts with the EU.
Compliance with the internationally valid standards is assessed by the manufacturer and certified private sector bodies that handle conformity assessment, the so-called Notified Bodies. Medical devices are divided into various classes and the documentation and assessment procedure required depend on the risk assessment for each. The visible result of a successful conformity assessment is the so-called CE mark. Medical devices with this mark can be placed on the market in Switzerland and in the EU.

Up-to-date information on medical devices can be found at the following:

The Swiss Therapeutic Products Act provides for experience with regard to the use of a medicinal product following its authorisation to be constantly and systematically collected and assessed, even after the product has been authorised. This is therefore of key importance, since at the moment of their authorisation, findings on the safety of medicinal products cannot be comprehensive. This is because the clinical trials with a new medicinal product – compared to its broad use in the population once it is placed on the market – can only be based on a relatively small number of patients. It is therefore possible that rare or extremely rare adverse reactions, interactions with other medicinal products, or other risks in connection with the use of the medicinal product are only identified during its more widespread use.


Market monitoring is therefore one of Swissmedic's key tasks.

 

The mandatory requirement for authorisation holders and also for healthcare professionals to report quality defects affecting an authorised medicinal product to Swissmedic (for example if the active pharmaceutical ingredient content is too low, the wrong tablets are contained in a blister or if impurities are discovered in a product) is laid down in the Therapeutic Products Act and the Medicinal Products Ordinance.
Depending on the type and potential risks of the quality defect that is reported or identified, Swissmedic initiates the appropriate measures. These include imposing so-called batch recalls, i.e. the manufacturing batch concerned by the quality defect is recalled from the market.
The authorisation of the medicinal products concerned is not usually affected.

A list of batch recalls for human medicinal products can be found at the following link:

A list of the recalls and other safety measures concerning medical devices can be found at the following link:

If a therapeutically important medicinal product that is authorised in Switzerland should be unavailable for a limited period of time as a result of delivery shortages on the part of the manufacturer (i.e. an out-of-stock situation), the authorisation holder may submit an application for the temporary marketing of the identical product (qualitative and quantitative composition) in a packaging intended for another country.
The application may be approved if the following criteria are fulfilled:

 

  • If the availability of the medicinal product is therapeutically important;
  • If there is no increased risk with regard to the safety of medicines;
  • If there is no equivalent alternative product available in Switzerland.

The applications approved by Swissmedic and the corresponding information letter from the firm can be found at the link below.

Medicinal products may only be distributed in Switzerland if they are authorised by Swissmedic (see under "Authorised medicinal products"). Once an authorisation is granted, however, it is not valid for an unlimited time but remains subject to the appropriate control mechanisms and reviews even after it is placed on the market (see under "Safety of medicines").
In the case of new medicinal products, companies must submit reports on the monitoring of the safety and efficacy of a medicinal product at regular intervals. The reports are assessed by Swissmedic. If necessary, the Agency proceeds to an adjustment of the authorisation, and in particular of the medicinal product information. In addition, usually five years following the granting of a first authorisation, companies must apply for the authorisation to be extended. If the authorisation holder does not submit an application for the extension to Swissmedic within the time limit or if the authorisation is revoked by Swissmedic, this leads to the authorisation being cancelled. The medicinal product may then no longer be distributed or dispensed as of a defined date.

Swissmedic may withdraw an authorisation not only for safety reasons, but also in the following cases:

 

  • If the authorisation holder decides to discontinue distribution;
  • If the medicinal product has not been placed on the market within three years after the authorisation is granted (so-called "sunset clause");
  • If, after being placed on the market, the medicinal product is not available on the market for three consecutive years (so-called "sunset clause").

In contrast to a withdrawal, the authorisation of a medicinal product may also be suspended for a defined time period. This may be necessary in order – initially – to carry out further investigations and tests before a final decision is taken. During the suspension period, the medicinal product may not be distributed and is not available for use. After the assessment is completed, Swissmedic decides whether to remove the suspension, whether the authorisation of the medicinal product must be adjusted, or whether it must be withdrawn.

The expiry or withdrawal of authorisations or suspensions that are imposed are published by Swissmedic in its monthly Swissmedic Journal.

The advantage of obtaining medicinal products in pharmacies, from druggists or from your doctor (if he / she dispenses them) is that they come from the official distribution channels approved by Swissmedic.
The situation is different if medicinal products are ordered from abroad, from the Internet. This can be extremely dangerous and can expose you to serious health risks. Medicinal products for sale on the Internet are often of insufficient quality, wrongly labelled or even knowingly falsified. It is possible that the products offered do not contain the active pharmaceutical ingredient declared, or contain different or impure active pharmaceutical ingredients. The Swiss authorities have no legal basis for preventing the activities of such providers since foreign suppliers are not governed by Swiss law. Those ordering the products therefore do so under their own responsibility. Swissmedic therefore issues regular warnings about the possible dangers of obtaining medicinal products from the Internet, and takes part in national and international campaigns on the subject.

Mail order of medicinal products is permitted in Switzerland under conditions defined by law. The corresponding licences are attributed by the Cantons. In accordance with legislation on therapeutic products, each individual mail order for medicinal products must be accompanied by a medical prescription. This also applies to medicinal products that can normally be obtained without a prescription. These provisions are intended to ensure that expert advice is provided before the order is placed.

Further information on risks, the legal basis, and obtaining medicinal products from the Internet can be found in our guideline on medicinal products and the Internet at the link below:

Guideline on medicines and the Internet
(16.08.2011, 52 KB, PDF)

The import and export of medicinal products for the private use of individuals is regulated by law.
The link below provides you with answers to the most frequently asked questions in this connection: