Studying at an international school, I always feel somewhat obligated to be evaluative on a global scale. So, as a sequel to last month’s article, I thought it would be appropriate to zoom out and take a global approach to the subject of expedited drug approval.
With globalization forcing the powers at be to maintain economies with a highly competitive edge, drug review administrations are under pressure to facilitate growth of the pharmaceutical industry in their respective nations.
Having already looked, in last month’s article, at the FDA’s drug approval expedition practices, I want to give a brief overview of what the rest of the world is doing to get vital drugs to market.
EMA – European Union
In 2016, the European Medicine Agency (EMA) launched their equivalent of the FDA’s Breakthrough Therapies designation. The PRIME designation is intended to “enhance support for the development of medicines that target an unmet medical need”.
If, during preliminary stages of development, a new drug application meets the requirements for PRIME, it receives special support from the EMA to speed up the development process and, if finally deemed eligible, it is awarded Accelerated Assessment to reach marketing authorization. Accelerated Assessment, the European equivalent of FDA’s Fast Track, reduces the duration of an application review from 210 to 150 days.
The general response to these policies have been different from what the FDA has faced in the USA. For example, the biggest critic of the Priority Review Voucher scheme is the FDA itself, as they complain that it allows drug manufacturers to buy their way through the approval system. In the EU, however, it has been national agencies that have criticized the EMA’s schemes the most. Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) has voiced its complete dissent towards the Accelerated Approval scheme of the EMA, claiming that it is undermining the safety of the review process.
CFDA – China
This past October, the Chinese government announced its new policies for the China Food and Drug Administration (CFDA). More drastic than what we’ve seen in the FDA and the EMA, the CFDA plans to fast-track applications by completely reforming its organization in order to make itself a more efficient regulatory body.
To deal with the backlog of new drug applications, CFDA staff numbers will be bolstered. Furthermore, fraudulent applications, a common practice for drug manufacturers in China, will be punishable by incarceration. Another policy will be ending the prohibition on biopharma companies from starting phase I trials in China (unless treatments are clinically proven in another country). This law was originally put in place to protect the Chinese people from unregulated human trials, but removing it will facilitate R&D within China’s own fledgling biotech industry.
All this reformative pressure is being applied by the chinese government as they are “eager to expand [China’s] pharmaceutical industry, given that China is the world’s second largest drug market”.
PMDA – Japanese
Japan’s ‘Sakigake’ designation system, another version of Fast-Track, was aimed at expediting approval of promising drugs developed in Japan, in order to approve them and help bring them to market before the rest of the world. The program began in June 2014 and has, since, evaluated around 50 candidates.
According to the PMDA, “any products considered must display a novel mechanism of action, be scalable commercially, show high efficacy and be developed and planned for approval in Japan ahead of the rest of the world”. Currently the ‘Sakigake’ system is evaluating 5 high profile potential products, 2 of which were submitted by Sanofi and Biogen’s Japan branches.
Similar to the other expedited-review designations, the ‘Sakigake’ system cuts down the review time from 12 to 6 months, prioritizes consultations, prioritizes premarket reviews and provides “substantial postmarketing safety measures”.
 “PRIME: priority medicines.” Research and development, European Medicines Agency, www.ema.europa.eu/ema/index.jsp?curl=pages%2Fregulation%2Fgeneral%2Fgeneral_content_000660.jsp. Accessed 29 Dec. 2017.
 Gameiro, Denise Neves. “EMA Launches its own Fast Track for Breakthrough Therapies.” Labiotech.eu, 9 Mar. 2016, www.labiotech.eu/ema-launches-fast-track-breakthrough-therapies/. Accessed 29 Dec. 2017.
 “Accelerated assessment.” Marketing authorisation, European Medicines Agency, www.ema.europa.eu/ema/index.jsp?curl=pages%2Fregulation%2Fgeneral%2Fgeneral_content_000955.jsp. Accessed 29 Dec. 2017.
 Taylor, Nick Paul. “National agency pushback against EMA fast track continues.” FierceBiotech, 30 Mar. 2017. Accessed 29 Dec. 2017.
 Cyranoski, David. “China announces plans to fast-Track drug approval.” Nature, 2017, doi:10.1038/nature.2017.22888.
 Cyranoski, David. “China cracks down on fake data in drug trials.” Nature, vol. 545, no. 7654, Nov. 2017, pp. 275–275., doi:10.1038/nature.2017.21977.
 Lane, EJ. “Japan’s MHLW lines up about 50 candidates for fast-Track ‘sakigake’ process.” FiercePharma, Questex, 23 Sept. 2015, www.fiercepharma.com/r-d/japan-s-mhlw-lines-up-about-50-candidates-for-fast-track-sakigake-process. Accessed 29 Jan. 2018.
 “Product Designation under the “SAKIGAKE Designation System”.” Product Designation under the “SAKIGAKE Designation System”, Ministry of Health, Labour and Welfare, 21 Apr. 2017, www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/170421-01.html. Accessed 29 Jan. 2018.