In 2020, the pharmaceutical industry and Swissmedic conducted its seventh 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 a small, 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.
Benchmarking 2020 – Comparison of Swiss approval times for human medicines with the EU and the USA and analysis of national authorisation procedures
This data analysis includes applications completed in the period from 1 January to 21 December 2019, and therefore covers the transitional phase between the old therapeutics product legislation and the new legislation, which entered into force on 1 January 2019 (revised Therapeutic Products Act, TPA2). The numerous innovations introduced during this process included harmonisation of the structure for variation applications with that of the EMA. Of particular relevance in this context is the reclassification of an additional indication as a type II variation and the simultaneous shortening of the processing period from a total of 480 to 390 calendar days (standard procedure). However, of the completed applications analysed in 2019, only 12 percent were processed according to the new rules. Next year's study for financial year 2020 will better reflect any effects of the new situation.
For the first time, gene and cell therapy products, as well as a separate analysis of the newly authorised biosimilars, were also taken into account for the 2019 period. However, the major changes that were restructured in the context of TPA2 were not analysed (e.g. new pharmaceutical form, new dosage recommendation).
76 companies (-4 percent) took part in this benchmarking study. They accounted for 83 and 88 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.
International benchmarking: Swissmedic compared with the EMA and the FDA
For a new application for a new active substance (NA NAS) in the standard procedure, the median value for the total throughput time in Switzerland was 555 calendar days (CD), i.e. 4 percent longer than the previous year, compared to 401 CD (-0.2 percent) for the EMA and 318 CD (-13 percent) for the FDA.
The median value for the total throughput time for an additional indication (AI) in the standard procedure in Switzerland was 380 CD (-9 percent), compared to 294 CD (+8 percent) for the EMA and 304 CD (+0.3 percent) for the FDA. The international comparison shows that the time to authorisation in Switzerland is longer than in other countries despite the acceleration achieved in this area. However, as the proportion of applications processed by the shortened procedures according to TPA2 increases, a further reduction in the processing times is expected in future.
For applications for known active substances (KAS) without innovation – i.e. generics – processed by the Swissmedic standard procedure, the median value for the total throughput time was 501 CD (+2 percent), compared to 397 CD (-19 percent) for the EMA and 1,298 CD (-44 percent) for the FDA. When the applications were processed in the procedure according to Article 13 TPA, the approval time was shortened by 41 percent compared to the standard procedure, with a median value of just 295 CD (+4 percent). In 2019, 44 percent (previous year: 49 percent) of the applications for a KAS without innovation were processed according to Article 13 TPA.
The total throughput time was also shortened for applications for KAS with innovation processed according to Article 13 TPA (56 percent of the applications); the reduction amounted to 52 percent by comparison with the standard procedure.
Of the new applications for biosimilars in the standard procedure, the median value for the total throughput time in Switzerland was just over 469 CD (-31 percent), compared to 440 CD for the EMA and 304 CD for the FDA.
New active substances and biosimilars
The longer period that companies are now given for responding to the List of Questions appears to have contributed to the increased total throughput time for NA NAS applications; however, the frequent occurrence of additional text review rounds – which proved to be more protracted than in the previous year – was also a contributory factor. By contrast, the approval time for biosimilars was reduced by around a third. This acceleration was achieved thanks to companies’ much faster response times and to the small number of additional text review rounds required.
Optimising the labelling phase
The duration of the scientific assessment between the milestones "Doc. OK" and "Preliminary decision of approval" is on a par with that of the FDA and other leading regulatory authorities (see publication dated 3 July 2020). It was already clear from previous benchmarking studies that reductions in the number of additional text review rounds and second preliminary decisions are crucial to faster processing. As these figures confirm, however, the measures implemented in recent years (see Swissmedic Journal 07/2017 and 05/2019) have not yet managed to achieve the desired effect: additional text review rounds and a second preliminary decision are still frequent occurrences (70 percent of NA NAS applications). A median figure of approx. 100 CD is lost as a result, and two-thirds of this delay is attributable to the processing time at Swissmedic. This issue must therefore be addressed (see Outlook).
The revised TPA2 legislation, the procedures according to Article 14 para. 1 let. abis-quater TPA and the option of temporary authorisation were further simplifying measures designed to accelerate the availability of medicines on the market. The Benchmarking Group hopes that the potential offered by these procedures will be exploited and subsequently analysed in future studies.
The application of the procedure according to Art. 13 TPA has also been extended to biosimilars with TPA2. This should be reflected in a marked reduction in total throughput time for financial year 2020.
As a response to the unsatisfactory situation for the labelling phase, Swissmedic has taken further measures so that in future the labelling dialogue takes place directly with the companies and at an earlier stage than currently (see Swissmedic Journal 06/2020); whenever possible, the review process will be concluded directly after the preliminary decision. Further measures to be implemented alongside the labelling dialogue are currently being discussed with the industry associations.
Last modification 18.08.2020