In 2021, the pharmaceutical industry and Swissmedic conducted their eighth joint benchmarking study on approval times for human medicines. A comparison of the approval times of the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and Swissmedic revealed the performance of Swissmedic as an independent national authorisation agency in relation to that of large, international reference authorities. As well as this international benchmarking, the study also contains a differentiated analysis of the national authorisation procedures.
Comparison of Swiss approval times for human medicines with the EU and the USA
This data analysis includes applications completed in the period from 1 January to 31 December 2020. The transitional phase between the old therapeutic products legislation and the new legislation, which entered into force on 1 January 2019, is still in progress. Of the completed applications analysed in 2020, the majority (77 percent) were processed according to the new Therapeutic Products Act (12 percent in 2019).
Access and Orbis applications – on which Swissmedic is collaborating with international partner authorities – and the recently introduced option of temporary authorisation were included for the first time in the 2021 study. However, the number was still too low to permit separate evaluation. Analyses of new applications for herbal medicines in a simplified procedure and the new procedure according to Article 14 para. 1 let. abis-quater TPA were also performed for the first time.
78 companies (+3 percent) took part in this benchmarking study. They accounted for 77 and 80 percent, respectively, of the overall market and the market for prescription-only medicines. These high percentages make it possible to draw meaningful conclusions from the analysis.
Overall, there is a trend at Swissmedic towards greater use of accelerated authorisation procedures (AAP, PPN) than in the previous year. Furthermore, applications for new active substances (NA NAS) and additional indications (AI) in the Orbis project were included for the first time. The impact of this can be seen in the corresponding analyses. Conversely, no significant changes in throughput times are evident for applications processed by the Swissmedic standard procedure.
New applications for new active substances (NAS)
Greater use of accelerated authorisation procedures (AAP and PPN) was made for NA NAS applications: 25 percent compared with 8 percent the previous year. The total throughput time in all procedures accordingly decreased by an impressive 20 percent compared with the previous year (427 calendar days [CD] versus 532 CD the year before). Swissmedic is therefore catching up with the EMA (395 CD).
The median value for the total throughput time in the standard procedure in Switzerland was 535 CD (-4 percent), compared to 459 CD (+14 percent) for the EMA and 305 CD (-4 percent) for the FDA.
It was not possible to analyse temporary authorisation on application in this study because 4 of the 5 applications analysed were initially submitted for processing using the standard procedure and were only granted temporary authorisation by Swissmedic at the conclusion of the application. Accelerated procedures were therefore not used for these applications.
Additional indications (AI)
The median value for the total throughput time for an additional indication in all procedures in Switzerland was 358 CD (-6 percent), compared to 270 CD (-10 percent) for the EMA and 184 CD (±0 percent) for the FDA. The median value in the standard procedure in Switzerland was 382 CD (±0 percent), compared to 270 CD (-9 percent) for the EMA and 303 CD (±0 percent) for the FDA.
There was, however, a clear reduction in the processing time for additional indications evaluated in conjunction with the FDA using Orbis. The throughput time for these AI in Switzerland was just 180 CD (-50 percent compared with the standard procedure).
Known active substances (KAS) without innovation (generics)
The median value for the total throughput time in the standard procedure at Swissmedic was 422 CD (-16 percent), compared to 446 CD (+12 percent) for the EMA and 1516 CD (+17 percent) for the FDA.
In 2020, 46 percent (+2 percent) of the KAS without innovation were processed according to Article 13 TPA; here the approval time was reduced by 25 percent compared to the standard procedure, and the median value was just 315 CD (+6 percent).
The procedure according to Article 13 TPA was used to process 3 of the 4 new applications for biosimilars, making it impossible to analyse the standard procedure. The median value for the total throughput time for biosimilars processed according to Article 13 TPA in Switzerland was 294 CD, compared to 450 CD for the EMA and 363 CD for the FDA.
Herbal medicinal products
Two new applications for herbal medicinal products were evaluated in the simplified procedure for the first time. The approval times are comparable to those for known active substances.
The greater use of accelerated authorisation procedures (AAP, PPN) and the international collaboration on Orbis made a major contribution to the reduction in throughput times.
Initial experience is showing that the inclusion of the new Orbis procedure in the repertoire enables a high intensity of evaluation to be combined with very short approval times. The continuing trend towards innovation in oncology makes it likely that the use of Orbis will bring about a lasting reduction in approval times for innovative medicinal products in the future.
The AAP procedure is used if companies request temporary authorisation when they submit the application. This offers companies a further opportunity to bring innovative medicinal products onto the market rapidly. The AAA Meeting introduced in 2020 is an additional element in ensuring that the most appropriate procedure can be determined at an early stage and efficiently in a dialogue between the companies and Swissmedic.
Swissmedic also took various steps to optimise the labelling phase in the second half of 2020, in particular with the aim of reducing the number of additional text review rounds (see the Swissmedic communication dated 07/2020). It is to be expected that these measures will start to take effect during the current year 2021, thus enabling applications processed using the standard procedure to be completed more rapidly too.
The next benchmarking study will look at the extent to which the use of temporary authorisation, Orbis applications and the measures to optimise the labelling phase are affecting throughput times.
Last modification 04.08.2021