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News about GMP/cGMP

2017-06-06

Swissmedic publishes Annual Report 2016

According to the Swiss Therapeutic Products Agency Swissmedic, the agency achieved its objectives last year. Regulatory approval was granted for more than 40 innovative medicinal products partially due to a fast-track procedure.

 

An increase of 50% of new active substances for the Swiss market shows that the pharmaceutical industry in Switzerland in continuing to invest heavily in research and into the development of medicines.

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.

Under certain circumstances medicinal products can be granted a marketing authorisation within 140 days provided that their quality, efficacy and safety are evaluated positively. 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 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 619 manufacturers and wholesalers were inspected.

The Swissmedic inspectors monitored primarily establishments in the pharmaceutical industry and 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.

In addition, Swissmedic agreed to intensify collaboration with two partner authorities abroad: two Memoranda of Understanding (MoU) were signed with the British MHRA (Medicinal and Health Products Regulatory Authority) and with COFEPRIS (Federal Commission for Protection against Sanitary Risk) in Mexico. 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.

Source:
Swissmedic
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