Swissmedic Annual Report 2016: A successful year – more innovative medicinal products approved
Bern, 30.05.2017 - The Swiss Therapeutic Products Agency Swissmedic achieved its objectives last year. Regulatory approval was granted for more than 40 innovative medicinal products. Furthermore, 99% of all submitted applications were completed on schedule. Swissmedic also focused on its oversight activities, performing 65 inspections of manufacturers and wholesalers. In addition, in 2016 Swissmedic agreed to intensify collaboration with two partner authorities abroad.
The Swissmedic Annual Report 2016 explains that, in the year under review, the Agency approved 42 medicinal products with new active substances for the Swiss market. This represents a 50% increase compared to 2015, when 28 of these medicinal products were approved.
This increase shows that the pharmaceutical industry in Switzerland is continuing to invest heavily in research into and the development of medicines and is making a substantial contribution to maintaining the attractiveness of Switzerland as a base for innovation.
The time factor
The time taken to complete the approval procedure as a proportion of the total time from development to market launch is an important factor in the success of a new medicine. Swissmedic has an accelerated approval procedure that takes into account the industry’s need for a faster turn-round. Under certain circumstances medicinal products can be granted a marketing authorisation within 140 days provided that their quality, efficacy and safety are evaluated positively. A regular approval procedure takes 330 days. Seven of the 42 applications for medicinal products with new active substances that were completed last year were processed using the accelerated approval procedure.
In 2016, Swissmedic received a total of 12,678 applications and 12,933 applications were completed. The rate of compliance with processing deadlines was 99%. At the end of 2016, 8,417 medicinal products were approved for the Swiss market, 734 of them veterinary medicinal products.
Important oversight function
In the course of its oversight activities, Swissmedic coordinated the Swiss inspection system and conducted 65 of its own inspections in the reporting period. Together with the four regional inspectorates operated by the Cantons, 619 manufacturers and wholesalers were inspected, compared to 565 in the previous year. The Swissmedic inspectors monitored primarily establishments in the pharmaceutical industry and the blood transfusion service and those involved with transplant products. They examined whether manufacturers of pharmaceutical products comply with the international quality standards of Good Manufacturing Practice. As regards wholesale companies, the focus was on the implementation of and compliance with the current European guidelines of Good Distribution Practice, which have been in force in Switzerland since January 2016.
Swissmedic on course for success – internationally too
In 2016, Swissmedic signed two Memoranda of Understanding (MoU) – one with the British partner authority Medicinal and Health Products Regulatory Authority (MHRA), the other with the Federal Commission for Protection against Sanitary Risk (COFEPRIS) in Mexico. This added two important partner authorities to Swissmedic’s international collaboration network. In October the Agency also organised the annual meeting of the heads of medicinal and therapeutic product authorities. The summit in Interlaken was attended by some 75 representatives from 23 countries. This was the first time that it had been held in Switzerland.Address for enquiries
Swissmedic, Swiss Agency for Therapeutic Products
Danièle Bersier, Media Spokesperson
+41 58 462 02 76
media@swissmedic.ch
Documents
Publisher
Swiss Agency for Therapeutic Products
http://www.swissmedic.ch/?lang=2
