The impact of changing regulatory environment on new drug approval

Source: Thomson Reuters life science and pharmacy 2016-08-02 the center for innovation in regulatory Sciences (CIRS) under Thomson Reuters intellectual property and technology group released a new R & D briefing entitled "the impact of regulatory environmental change on the approval of new drugs by six major pharmaceutical agencies in the world in 2006-2015" This report is CIRS annual regulatory approval briefing, which evaluates the new active substances (NAS) approved by the U.S Food and Drug Administration (FDA), European Drug Administration (EMA) and Japan drug and medical device administration (PMDA) in 2015 In addition to the three ICH countries, the briefing also includes approvals from the Health Canada, Swissmedic and TGA The brief analysis reviewed the approval situation in the past decade, showed the trend of new drug approval of the above six regulatory agencies in 2006-2015, and especially analyzed the situation of different review types, accelerated regulatory path, treatment areas and general approval The key message of this briefing is: the gap of approval time between regions is narrowing in the past few years, and the median value of the gap of approval time between regulators in different regions is decreasing, which will continue in 2015 In 2006, the gap between the longest and shortest approval time of regulatory agencies was 530 days, and in 2015, it was reduced to 180 days This may be because companies have improved the quality of applications submitted, and regulators have taken different measures, such as pre application, to verify the quality of application documents before review Interestingly, the gap between the total review time of FDA and PMDS in 2015 further widened The review time difference between EMA, Health Canada and TGA and FDA is 66 days, but the gap is narrowing Since 2006, the approval time of PMDA has been greatly reduced, because the organization continues to improve the approval process and commits to invest more resources In the United States, according to the fifth edition of the prescription drug user payment Act (PDUFA), two months of filing time has been added to the review schedule, resulting in a slight increase in FDA approval time since 2013 This modification of PDUFA aims to further improve the quality of applications submitted by pharmaceutical companies, and ultimately optimize the FDA's review process, increasing the number of applications that have been successfully approved in the first round of review In recent years, the shortening of the time gap between the approval of six regulatory agencies has made more overseas products approved in a shorter time It can be argued that a real comparison of different regulators is based on a study of the products they approve The briefing selected 18 NAS approved by 6 regulatory agencies from 2006 to 2010 and 36 NAS approved by 2011 to 2015 for analysis, and found that more overseas products were approved in 2011 to 2015 within the same time span As expected, from 2006 to 2010 and from 2011 to 2015, the country with the fastest approval rate for overseas products is the United States However, although Japan is the slowest country to approve overseas products in both time periods, the time difference between application submission and approval is decreasing This is due to the initiative of PMDA to accelerate drug review and the change of strategies of various companies For example, pharmaceutical companies now choose to submit applications to PMDA earlier The analysis of the gap between the submission time and approval time of these drugs in six regulatory agencies does not reflect some factors that may affect the time to market of drugs, such as the company's strategy of submitting product applications, the review schedule of various regulatory agencies, and some factors specific to products These unique factors include specific areas of treatment, or products designed to meet unmet medical needs, which in turn affect whether approval of the drug will accelerate In fact, there was a significant increase in the number of NAS approvals for cancer and immunomodulatory therapy in 2011-2015 compared with 2006-2010, and drugs in these two treatment areas now account for about one third of all approved NAS in six regulatory agencies In general, the approval speed of anti-cancer and immune regulation is second only to that of anti infective products in six regulatory agencies, ranking second, with a median approval time of 351 days, which may also be due to the more frequent use of accelerated review paths for such products Based on the time of application submission and approval, the drugs approved by six regulatory agencies are divided into three types Between 2014 and 2015, only products approved by one regulatory agency were classified as category I (type 1); category II products were approved by other regulatory agencies at the same time, and overseas applications for such products were submitted before the first global approval (type 2); category III products were subsequently approved after the first global approval (type 3) This classification reflects the time when six regulators approved NAS in 2014-2015, and whether these agencies will evaluate based on the review information of other agencies before the product Of the six regulators, the largest number of NAS (type 1) approved by FDA and PMDA is only one The largest number of products (type 2) that are approved at the same time as other regulators and that have applied for submission earlier than the world's first approval is EMA PMDA, Health Canada, Swiss medical authority and TGA have approved the largest number of applications (type 3) submitted after the first global approval Generally, except for Health Canada, other regulatory agencies approve type 1 products with the longest approval time In addition, TGA does not approve any NAS of type 1 The Swiss medical authority and PMDA approved type 3 NAS the fastest, probably because they used information from other agencies in their reviews.