LONDON, Aug 16 (APM) - Japan has the shortest median time for new drug approvals among the major regions for drug regulation, according to a new study.
The analysis, published in the journal Nature, says the median time for Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to approve a new drug in 2015 was 311 days, ahead of the U.S. Food and Drug Administration (FDA), which took 333 days, Russia's Roszdravnadzor, which took 335 days, and Health Canada, which took 361 days.
In Australia, the median time for approval for the Therapeutics Goods Administration (TGA) was 373 days, while it was even longer in Europe, taking 422 days for the European Medicines Agency (EMA) and 464 days for Swissmedic.
The Chinese Food and Drug Administration (CFDA) had by far the longest median time for approval at 639 days, according to the analysis, which was published last Friday.
Japan's speedy timelines follow improvements being made at the agency, including hiring more staff in a bid to bring 80% of standard approval reviews within a 12-month time limit by 2020. The PMDA told APM in September that it was slightly behind schedule to meet these targets, but that drug approvals had still sped up (APMMA 49674).
Study rationale
The study 'Structural and procedural characteristics of international regulatory authorities' was carried out by a team at Novo Nordisk and the European Center of Pharmaceutial Medicine/Insitute of Pharmaceuticals at University of Basel in Switzerland.It aims to give an overview of the different characteristics of the major regulators across the world in a bid to aid drug development, evaluation and filing.
Data were gathered from the published literature and the internet, interviews with the regulatory personnel from different regulatory authorities and a survey administered to regulatory personnel in the pharmaceutical industry.
Money and resources
Areas covered in the analysis include the budget of each regulator, with the greatest amount of funding unsurprisingly for the U.S. FDA, which had a budget of $1.23 billion for the fiscal year 2016.This was compared to $342 million for the EMA, $241 million for the PMDA, $250 million for the CFDA and $108 million for both Health Canada and Swissmedic.
There is also high variability in the number of technical reviewers across regulatory authorities.
The FDA has the most internal reviewers at around 2,000, while the EMA has a network consisting of over 4,500 experts providing scientific expertise to the agency, including those from the country-level regulatory authorities in the European Union, such as the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The PMDA has 560 reviewers, while the CFDA had only about 120 staff in its Center of Drug Evaluation to perform scientific evaluations. However, the State Council of China has since taken measures to hire and train more technical evaluators to clear the backlog of applications. By January 2017, the number of evaluators had been increased to about 300.
Despite acknowledging that a direct comparison between the numbers of new drug applications is difficult due to differing definitions between regulators, the study still provide figures on submission and approvals for 2015 and 2016.
There were 61 drug submissions to the EMA in 2015 and 68 in 2016, with 39 approvals in 2015 and 27 in 2016.
For the U.S. FDA, there were 35 submissions in 2015 and 41 in 2016. The number of approvals fell drastically from 45 in 2015 to 22 in 2016.
Japan's PMDA took over as the regulator with the most approval in 2016 at 48, compared to 42 in 2015. It received 124 submissions in 2015.
There were no submission figures for the CFDA, although the number of approvals, excluding traditional Chines medicine, were 72 in 2015 and 31 in 2016.
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