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P228: Measuring Time-to-market for New Medicines in Seven Asian Countries between 2016-21, following Review by US FDA or EMA

Poster Presenter

Adem Kermad

Senior Research Analyst
Centre for Innovation In Regulatory Science (CIRS)
United Kingdom

Objectives

To investigate the trend in roll-out time (comprised of submission lag and regulatory review time), between 2016-21 in 7 Asian countries, for new active substances (NASs) approved first by US FDA or EMA; and to understand the drivers behind the trends.

Method

Data was collected on application submissions and approvals from 17 major pharma companies that participated in a benchmarking programme. Analysis focused on 3-year rolling means of intervals calculated from key milestone dates for NASs approved in 1 or more of 7 Asian countries.

Results

7 Asian countries were analysed: China (CHN, 53 NAS approved 2016-21), India (IND, 35), Indonesia (IDN, 32), Malaysia (MYS, 48), Singapore (SGP, 46), S. Korea (KOR, 42), and Taiwan (TWN, 55). Between 2016-21, the roll-out time (time between first market approval and local market approval as a 3-year rolling mean) was broken down into submission lag (first market approval to local market submission) and review time (local market submission to approval). On the whole, roll-out time decreased across the 7 countries (-81 days; -7%). For IDN (-598; -29%), MYS (-147, -13%), SGP (-224; -26%), KOR (-159; -23%), and TWN (-309; -32%) roll-out times decreased notably. The decrease in roll-out time to MYS was associated with a decrease in submission lag (-165; -25%), and similar was true for SGP (-204; -48%) and KOR (-171; -52%). For IDN and TWN, decreased roll-out time was associated with decreased time in both constituting intervals. Review time was broken down into 3 intervals: time to receive first question following application submission, time between receiving the first question to last response being submitted to the agency, and time to approval following submission of last response. For IDN, the decrease in review time was associated with decreases in the time to receive first question following application submission, and the time to approval following submission of last question response. Results were broken down further to understand whether trends in roll-out time and the constituting intervals correlated with product or process characteristics. Where a decrease in roll-out time was associated with a decrease in review time, no notable differences in the use of reliance assessment routes were observed. The type of NAS (chemical/biologic) and use of priority review by the agency generally did not have a clear impact on review time. There was also no clear impact on submission lag depending on whether the sponsor fast-tracked submission of the application.

Conclusion

This analysis sought to investigate the trend in roll-out time between 2016-21 in 7 Asian countries, for NASs approved first by US FDA or EMA; and to evaluate the drivers. Roll-out time decreased in general across the 7 countries over this period. This decrease was primarily associated with a decrease in submission lag time, although for TWN and IDN a decrease in regulatory review time can also be considered a contributing factor. Interestingly, there was no consistent impact on submission lag or review time across the countries based on product characteristics or pathways utilised. Measuring changes in agency processes, regulatory review times, and the time to market for NASs is of growing importance to agencies, companies, and to other stakeholders. Methods with which the changes in roll-out time could be measured in these countries should be explored in more detail. Submission lag, for example, could be studied in terms of factors influencing company strategy and local agency requirements. In addition, whilst the time to receive first question from the agency and the time to approval following submission of last question response can largely be attributed to the agency, the time between receiving the first question to last question response being submitted to the agency can often be a product of both agency and sponsor time, particularly where there are multiple cycles of scientific assessment. Therefore, deeper like-for-like comparisons of regulatory review times could be achieved by not only analysing the major components of the review process (e.g., validation, scientific assessment, and authorisation) but by analysing total agency time during scientific assessment. Highlighting where time is devoted and identifying areas for development could help to ensure and improve the effectiveness and efficiency of these processes, ultimately facilitating faster access to medicines for patients.