Major improvements in the regulatory environment as well as changes in strategies of multinational companies have led to a decrease in the time to marketing authorization as well as an increase in the number of medicines that have become available over the last decade across six major regulatory agencies, a new study from the Centre for Innovation in Regulatory Science (CIRS) shows.
The six agencies, studied from 2008 through 2017, included the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).
CIRS experts found that the number of common products approved by six major regulatory agencies increased from 12 in 2008-2012, to 51 in 2013-2017.”
CIRS experts found that the number of common products approved by all six agencies increased from 12 in 2008-2012, to 51 in 2013-2017. The findings have been released in R&D Briefing 67 from CIRS, titled “New drug approvals in six major authorities 2008-2017: Focus on the evaluation of medicines and company size.”
Underlying factors influencing the overall time it takes for a new medicine to be submitted and then approved by an agency, CIRS noted, include company strategy, the conduct and the type of the review process, the type of the product and its therapeutic area; each of these aspects is analyzed and discussed in this study.
The study found that one of the key factors that may determine the likelihood and timing of submission is the size of the sponsor…”
Nevertheless, the study found that one of the key factors that may determine the likelihood and timing of submission is the size of the sponsor, where a medicine may be less likely to become internationalized beyond its first country of submission if it is developed by a smaller company.
Figure 1. New active substance (NAS) median approval time for six regulatory authorities in 2008 – 2017.
Focus on facilitated regulatory pathways
The study also looked at the impact of facilitated regulatory pathways (FRPs). All six agencies now offer an expedited priority system (referred to by the EMA as an “Accelerated Assessment” and by the other five agencies as “Priority Review”) designed to hasten the review process of promising new active substances.
TGA implemented its priority system in 2017 but no expedited approvals were granted that year. Nevertheless, the agency has been accepting applications, with first decisions expected this year.
In 2016, the ratio of expedited approvals to standard reviews was the highest for the FDA (62%), followed by PMDA (36%), Swissmedic (24%), Health Canada (18%) and EMA (17%). The proportion of expedited approvals has been consistently high for FDA and PMDA in the last few years, but has in fact increased when comparing 2008 – 2012 to 2013 – 2017 for all five agencies. EMA experienced the most notable increase from 7% in 2008 – 2012 to 16% in 2013 – 2017, followed by Swissmedic (10% to 22%), PMDA (22% to 45%), FDA (43% to 55%) and Health Canada (18% to 21%).
Figure 2. NASs approved in all six authorities in 2008-2012 (12) compared to 2013-2017 (51), as well as the % of NASs approved as expedited
The large increase within EMA is likely a result of the revision of the guidelines for Accelerated Assessment by the agency in 2015, where the updated guidelines are expected to optimize the use of this tool by companies.”
The large increase within EMA is likely a result of the revision of the guidelines for Accelerated Assessment by the agency in 2015, where the updated guidelines are expected to optimize the use of this tool by companies. The CIRS paper noted that more time is needed to see whether a further increase will take place in the use of the priority pathways, particularly with the launch of the PRIority MEdicines (PRIME) scheme in 2016 at EMA, which is specifically designed to promote the use of accelerated assessment for medicines that aim to address unmet medical need.
The full report from the author and her colleagues is available here from CIRS: “New drug approvals in six major authorities 2008-2017: Focus on the evaluation of medicines and company size.”
The Centre for Innovation in Regulatory Science Limited (CIRS) is a neutral, independently managed UK-based subsidiary company, forming part of Clarivate Analytics (UK) Limited. CIRS’ mission is to maintain a leadership role in identifying and applying scientific principles for the purpose of advancing regulatory and HTA policies and processes. CIRS provides an international forum for industry, regulators, HTA and other healthcare stakeholders to meet, debate and develop regulatory and reimbursement policy through the innovative application of regulatory science and to facilitate access to medical products through these activities. This is CIRS’ purpose. CIRS is operated solely for the promotion of its purpose. The organisation has its own dedicated management and advisory boards, and its funding is derived from membership dues, related activities, special projects and grants. (www.cirsci.org)