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In order to narrow the gap with the review efficiency of mature regulatory agencies such as FDA and EMA, other countries around the world are also making efforts to build accelerated drug approval paths under agile regulatory systems (Table 1)
.
Globally, both major and emerging markets have established expedited review or conditional approval pathways over the past 10 years
A few days ago, the journal Drug discovery today (IF: 7.
851) published a research report by the team of Professor Li Ning and Dr.
Wang Shuhang from Cancer Hospital/Drug Clinical Research Center (GCP), Chinese Academy of Medical Sciences, and systematically reviewed the 10 magnificent global accelerated approval of new drugs for rare tumors.
year course
.
Medicinal Rubik's Cube Med is authorized to compile, and successively introduces the accelerated approval pathways and orphan drug qualification policies used in the United States, China and many countries around the world, as well as oncology drugs approved through these pathways in the past 10 years
.
This article is the third in a series of reports - the global chapter
The purpose of this article is not to elaborate on the nuances of each country's regulatory system, but to highlight key themes in the operation of various regulatory systems, and to give examples relevant to individual national regulatory agencies
.
Table 1: Accelerated approval procedures in other countries or regions
Cooperation approval and supervision mutual trust
Cooperation approval and supervision mutual trustAs the world economy and medical system become increasingly globalized, the time has come to improve efficiency through cooperative approval between regulatory agencies.
The implementation of mutual trust in regulation based on harmonizing the regulatory systems of various countries around the world is an increasingly popular review strategy
.
For example, a regulatory agency (eg, the Swiss Medicines Agency, Swissmedic) can provide regulatory advice for products intended for foreign markets under the Marketing Authorization for Global Health Products (MAGHP)
Another way of mutual trust is the equivalence agreement adopted by Mexico, Costa Rica and Singapore.
Only the key parts of the listing application dossier subject to local regulatory requirements are reviewed in a targeted manner, which greatly shortens the approval time
.
Drugs approved through the equivalence agreement pathway can often reduce approval time from more than a year to about 3 or 4 months
Other international regulatory cooperation projects
Other international regulatory cooperation projectsOther projects to promote international regulatory cooperation are also being rolled out
.
A coalition of regulators from Australia, Canada and the United States met in September 2019 to launch Project Orbis, a new strategy for the simultaneous submission and review of marketing applications for oncology indications in multiple countries
Multiple expedited approval paths
Multiple expedited approval pathsVarious other accelerated approval pathways are also being implemented in various countries around the world to address potential medical needs
.
The Accelerated Approval Pathway is used by several countries to facilitate rapid approval of drugs, including Saudi Arabia, Brazil and Israel
In addition, Korea allows applicants to submit data in modules by regulatory requirements on a rolling application basis
.
Brazil and Taiwan can process and issue conditional approvals for marketing applications based on surrogate endpoints or data from Phase II studies
Provide financial incentives to sponsors
Provide financial incentives to sponsorsIn addition to improving the processing efficiency of marketing application materials, other countries offer financial incentives to sponsors to incentivize them to seek accelerated licensing
.
Japan's PMDA launched the Sakigake project in 2015, and drugs approved under this route receive a 10%-20% price increase after listing
As regulatory approval pathways around the world become standardized and unified, and countries can better collaborate, the median time to approval for a drug is bound to shrink significantly to fill previously unmet medical needs
.
Including the recently launched Sakigake program, 37 designations have been made, and 10 drugs have been approved as of August 2020
.
It is worth noting that 8 of these drugs are new drugs that have never been approved elsewhere before (viltolarsen, baloxavir marboxi, gilteritinib fumarat, borofalan, tepotinib, entrectinib; meglumine meglumine new indications or doses, western new formulations of roolimus)
.
Although exemplified in the non-oncology field, the emergency approval in response to the COVID-19 outbreak is the best example of the efficiency of the accelerated approval pipeline
.
In response to COVID-19, Brazil's National Health Surveillance Agency has granted special access to various therapeutics, diagnostics and supportive medical devices
.
Strategically deploying the resources of the regulatory system at a critical time has undoubtedly saved countless lives around the world, and the authors hope that future therapies through accelerated approval will play a greater role in addressing key challenges in oncology treatment and other unmet needs
.
For the original text, see: Wang S, Yang Q, Deng L, Lei Q, Yang Y, Ma P, Men Y, Yung BC, Lee RJ, Zhang M, Li N.
An overview of cancer drugs approved through expedited approval programs and orphan medicine designation globally between 2011 and 2020.
Drug Discov Today.
2021 Dec 29:S1359-6446(21)00572-9.
(https://doi.
org/10.
1016/j.
drudis.
2021.
12.
021)
