Executive Leadership | Editor’s Message
To Our Readers
The Need for Speed
Alberto Grignolo
Editor
Fellow of DIA
dozen years ago I visited the office of a world-renowned oncologist. As I waited for him to arrive, I glanced at the numerous awards, recognitions, and accolades displayed in his spacious office; all very impressive.
But one particular object drew my attention and remains etched in my memory to this day: a small, simple, lucite-encased white sign displayed prominently on his desk that read, “For a cancer patient, WAIT is a four-letter word.”
In American culture, a four-letter word is an obscenity, an insult not to be used in polite company. In this case, the clear message was that “waiting” is an insulting and unacceptable call to inaction for cancer patients and, by extension, for many other people affected by life-threatening diseases. When your life’s clock is rapidly counting down to zero, waiting patiently and endlessly for a cure is not an attractive option.
In rising numbers, regulators understand this and are taking action. On September 24, 2002, an editorial in The Wall Street Journal carried the headline “FDA to Patients: Drop Dead,” and accused FDA of being a bureaucratic maze out of which few cancer therapies emerged, and too slowly. Fast forward to the 2011-2017 timeframe, when FDA approved 69 new drugs for various cancer indications; in 2017 alone, FDA approved 15 therapies for cancer and cleared 46 new drugs overall–the highest total since 1996. The average time to approval of cancer drugs in this six-year period was six to seven months. The median time to approval of all drugs in 2017 was a historically-low eight months. FDA to Patients: We Want You Alive and Well.
Related Resources
CDER 2017 New Drug Therapy Approvals
FDA Achieves Historically Low Eight-Month Median Drug Review Time in 2017
EMA Human Medicines Highlights 2017
Health Canada: Guidance for Industry: Priority Review of Drug Submissions
China: Regulatory Reform 2.0 Changes the Game
Korea to Introduce Fast-Track Review for Cutting-Edge Biologics, Devices
Without a doubt, researchers and drug developers in both the public and private sectors around the world deserve huge credit for the scientific innovations that have delivered hope and cures to millions. Legislators and regulators have done their part by opening pathways that are speeding new medicines to approval faster than ever before. The US has led the way with Breakthrough Therapy Designations, Accelerated Approvals, Fast Track, QIDP, Priority Reviews; 61% of the drugs approved by FDA in 2017 used one or more of these pathways. The European Union has Conditional Marketing Authorizations, PRIME, Authorizations Under Exceptional Circumstances, Adaptive Pathways and Accelerated Assessments; the European Medicines Agency (EMA) used one of these pathways for 31% of its 2017 approval recommendations, which included 11 cancer drugs. Japan has Priority Reviews, Conditional Approvals, and sakigake Designations. Canada has a Priority Review pathway. China is accelerating its review process for both clinical trial applications and marketing applications, and is considering a Conditional Approval pathway as well as the acceptance of foreign clinical data in marketing applications. Brazil has a Priority Review process for new medicines. Now comes word that South Korea will implement a fast-track review process for cutting-edge biologics for life-threatening diseases by the end of 2018.
All of this is good news for patients – as long as rapid regulatory approvals are followed by swift and affordable patient access to these approved medicines.
At Global Forum we follow and report these and related developments because speed of approval and unfettered access to safe and effective medicines serve the best interests of patients and promote the health of the world.
In this issue we cover cutting-edge developments in cancer immunotherapy and proteomics, regulatory harmonization in West Africa, the Kyoto Summit of Heads of Medicines Regulatory Agencies and ICMRA, and important developments in Australia, Canada, and Mexico. The pace of change is accelerating.
Speed is going global.
Alberto Grignolo, PhD
Global Forum Editor
Fellow of DIA
Send your feedback on this issue to:
Publications@DIAGlobal.org
Related Resources
CDER 2017 New Drug Therapy Approvals
FDA Achieves Historically Low Eight-Month Median Drug Review Time in 2017
EMA Human Medicines Highlights 2017
Health Canada: Guidance for Industry: Priority Review of Drug Submissions
China: Regulatory Reform 2.0 Changes the Game
Korea to Introduce Fast-Track Review for Cutting-Edge Biologics, Devices
Without a doubt, researchers and drug developers in both the public and private sectors around the world deserve huge credit for the scientific innovations that have delivered hope and cures to millions. Legislators and regulators have done their part by opening pathways that are speeding new medicines to approval faster than ever before. The US has led the way with Breakthrough Therapy Designations, Accelerated Approvals, Fast Track, QIDP, Priority Reviews; 61% of the drugs approved by FDA in 2017 used one or more of these pathways. The European Union has Conditional Marketing Authorizations, PRIME, Authorizations Under Exceptional Circumstances, Adaptive Pathways and Accelerated Assessments; the European Medicines Agency (EMA) used one of these pathways for 31% of its 2017 approval recommendations, which included 11 cancer drugs. Japan has Priority Reviews, Conditional Approvals, and sakigake Designations. Canada has a Priority Review pathway. China is accelerating its review process for both clinical trial applications and marketing applications, and is considering a Conditional Approval pathway as well as the acceptance of foreign clinical data in marketing applications. Brazil has a Priority Review process for new medicines. Now comes word that South Korea will implement a fast-track review process for cutting-edge biologics for life-threatening diseases by the end of 2018.
All of this is good news for patients – as long as rapid regulatory approvals are followed by swift and affordable patient access to these approved medicines.
At Global Forum we follow and report these and related developments because speed of approval and unfettered access to safe and effective medicines serve the best interests of patients and promote the health of the world.
In this issue we cover cutting-edge developments in cancer immunotherapy and proteomics, regulatory harmonization in West Africa, the Kyoto Summit of Heads of Medicines Regulatory Agencies and ICMRA, and important developments in Australia, Canada, and Mexico. The pace of change is accelerating.
Speed is going global.
Alberto Grignolo, PhD
Global Forum Editor
Fellow of DIA
Send your feedback on this issue to:
Publications@DIAGlobal.org