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.
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 Swissmedic also intervenes in the case of quality problems, ensuring that defective products are withdrawn from the market.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.