Posted 10 February 2017 By Michael Mezher
The head of Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Tatsuya Kondo, on Thursday released a paper discussing his vision for a patient-centric, regulatory science-driven and evidence-based system for medicine in Japan.
"'Rational Medicine' is the idea that a patient-centric system should be createda system under which optimal medical care from the patient's point of view, which is based on the latest scientific knowledge, is providedfrom the perinatal to the final stages of life," says Kondo, who has served as PMDA's Chief Executive since 2008.
To move toward that ideal, Kondo says PMDA will focus its efforts in four key areas:
After its founding in 2004, PMDA struggled to keep up with other major regulators, and was consistently behind the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the time it took to review new drugs.
However, in recent years, PMDA has made significant strides toward reducing review times, and in 2014, following the introduction of its "Sakigake" designation system for accelerating access to innovative drugs, PMDA surpassed both FDA and EMA in median review times for new drugs.
"[PMDA] will strive to further shorten review times in 2017 through active use of the Sakigake designation system," Kondo says.
As part of its regulatory science efforts, Kondo says PMDA's Science Board will focus on three areas in 2017: better methods for assessing clinical studies for rare drugs, identifying areas of research that "bottleneck" drug development and looking into the use of artificial intelligence technologies in medicine.
Kondo also says PMDA is working to launch a dedicated Regulatory Science Center in 2018.
"This center will actively promote 'Rational Medicine' in collaboration with medical practitioners and academia, working on the basis of regulatory science. Its goal will include the formulation of guidelines to encourage the optimal use of novel medical products with innovative mechanisms of action," Kondo says.
Also in 2018, Kondo says PMDA hopes to make its database for real-world safety data fully operational. According to Kondo, once fully operational the Medical Information Database Network (MID-NET) will be made available to drugmakers and other third parties for use in postmarket surveillance activities.
PMDA
Read the rest here:
PMDA Head Talks Priorities for 'Rational Medicine' - Regulatory Focus
- Yes, But. The Annotated Atlantic. - November 7th, 2009 [November 7th, 2009]
- Health Insurance Benefit Costs by Region - November 8th, 2009 [November 8th, 2009]
- For an Operator, Please Press... - November 8th, 2009 [November 8th, 2009]
- Pollyanna With a Pen: Maine Governor Signs 18 New Health Care Bills into Law - November 8th, 2009 [November 8th, 2009]
- AMA Sounds the Alarm, Medicare Making Yet Another Attempt to Cut Reimbursement - November 8th, 2009 [November 8th, 2009]
- Mass Governor Asks Blue Cross to Keep Higher Employer Contribution - November 8th, 2009 [November 8th, 2009]
- Lifespan and Care New England Plan Monopoly (Again) - November 8th, 2009 [November 8th, 2009]
- Dirigo Health: Con Artists, Liars, and Thieves? - November 8th, 2009 [November 8th, 2009]
- New Orleans: Health Challenges - November 8th, 2009 [November 8th, 2009]
- August a Flurry of Activity - November 8th, 2009 [November 8th, 2009]
- Maine's Dirigo Health Savings One-Third of Original Estimate - November 8th, 2009 [November 8th, 2009]
- “Methodolatry”: My new favorite term for one of the shortcomings of evidence-based medicine - November 8th, 2009 [November 8th, 2009]
- Suzanne Somers’ Knockout: Dangerous misinformation about cancer (part 1) - November 8th, 2009 [November 8th, 2009]
- A science-based blog about GMO - November 8th, 2009 [November 8th, 2009]
- A Not-So-Split Decision - November 8th, 2009 [November 8th, 2009]
- Military Medicine in Iraq - November 8th, 2009 [November 8th, 2009]
- The effective wordsmithing of Amy Wallace - November 8th, 2009 [November 8th, 2009]
- A Science Lesson from a Homeopath and Behavioral Optometrist - November 8th, 2009 [November 8th, 2009]
- Join CFI in opposing funding mandates for quackery in health care reform - November 8th, 2009 [November 8th, 2009]
- Mainstreaming Science-Based Medicine: A Novel Approach - November 8th, 2009 [November 8th, 2009]
- Those who live in glass houses… - November 8th, 2009 [November 8th, 2009]
- J.B. Handley of the anti-vaccine group Generation Rescue: Misogynistic attacks on journalists who champion science - November 8th, 2009 [November 8th, 2009]
- When homeopaths attack medicine and physics - November 8th, 2009 [November 8th, 2009]
- The cancer screening kerfuffle erupts again: “Rethinking” screening for breast and prostate cancer - November 8th, 2009 [November 8th, 2009]
- All Medicines Are Poison! - November 8th, 2009 [November 8th, 2009]
- When Loud Wins: Will Your Tax Dollars Pay For Prayer? - November 8th, 2009 [November 8th, 2009]
- It’s All in Your Head - November 8th, 2009 [November 8th, 2009]
- The Skeptical O.B. joins the Science-Based Medicine crew - November 8th, 2009 [November 8th, 2009]
- The Tragic Death Toll of Homebirth - November 8th, 2009 [November 8th, 2009]
- What’s the right C-section rate? Higher than you think. - November 8th, 2009 [November 8th, 2009]
- Recombinant Human Antithrombin – Milking Nanny Goats for Big Bucks - December 13th, 2009 [December 13th, 2009]
- Does C-section increase the rate of neonatal death? - December 13th, 2009 [December 13th, 2009]
- Man in Coma 23 Years – Is He Really Conscious? - December 13th, 2009 [December 13th, 2009]
- Why Universal Hepatitis B Vaccination Isn’t Quite Universal - December 13th, 2009 [December 13th, 2009]
- Ontario naturopathic prescribing proposal is bad medicine - December 13th, 2009 [December 13th, 2009]
- Naturopaths and the anti-vaccine movement: Hijacking the law in service of pseudoscience - December 13th, 2009 [December 13th, 2009]
- The Institute for Science in Medicine enters the health care reform fray - December 13th, 2009 [December 13th, 2009]
- Neti pots – Ancient Ayurvedic Treatment Validated by Scientific Evidence - December 13th, 2009 [December 13th, 2009]
- Early Intervention for Autism - December 13th, 2009 [December 13th, 2009]
- A temporary reprieve from legislative madness - December 13th, 2009 [December 13th, 2009]
- A critique of the leading study of American homebirth - December 13th, 2009 [December 13th, 2009]
- Lose those holiday pounds - December 13th, 2009 [December 13th, 2009]
- Endocrine disruptors—the one true cause? - December 13th, 2009 [December 13th, 2009]
- Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome - December 13th, 2009 [December 13th, 2009]
- Evidence in Medicine: Experimental Studies - December 13th, 2009 [December 13th, 2009]
- Midwives and the assault on scientific evidence - December 13th, 2009 [December 13th, 2009]
- The Mammogram Post-Mortem - December 13th, 2009 [December 13th, 2009]
- An Influenza Recap: The End of the Second Wave - December 13th, 2009 [December 13th, 2009]
- The End of Chiropractic - December 13th, 2009 [December 13th, 2009]
- Cell phones and cancer again, or: Oh, no! My cell phone’s going to give me cancer! (revisited) - December 20th, 2009 [December 20th, 2009]
- Another wrinkle to the USPSTF mammogram guidelines kerfuffle: What about African-American women? - December 20th, 2009 [December 20th, 2009]
- Acupuncture, the P-Value Fallacy, and Honesty - December 20th, 2009 [December 20th, 2009]
- The One True Cause of All Disease - December 20th, 2009 [December 20th, 2009]
- Communicating with the Locked-In - December 20th, 2009 [December 20th, 2009]
- Are the benefits of breastfeeding oversold? - December 20th, 2009 [December 20th, 2009]
- Measles - December 20th, 2009 [December 20th, 2009]
- Radiation from medical imaging and cancer risk - December 21st, 2009 [December 21st, 2009]
- Multiple Sclerosis and Irrational Exuberance - December 21st, 2009 [December 21st, 2009]
- Medical Fun with Christmas Carols - December 22nd, 2009 [December 22nd, 2009]
- Lithium for ALS – Angioplasty for MS - December 23rd, 2009 [December 23rd, 2009]
- “Toxins”: the new evil humours - December 24th, 2009 [December 24th, 2009]
- 2009’s Top 5 Threats To Science In Medicine - December 24th, 2009 [December 24th, 2009]
- Buteyko Breathing Technique – Nothing to Hyperventilate About - December 26th, 2009 [December 26th, 2009]
- The Graston Technique – Inducing Microtrauma with Instruments - December 29th, 2009 [December 29th, 2009]
- The “pharma shill” gambit - December 29th, 2009 [December 29th, 2009]
- Ginkgo biloba – No Effect - December 30th, 2009 [December 30th, 2009]
- Oppose “Big Floss”; practice alternative dentistry - January 1st, 2010 [January 1st, 2010]
- Causation and Hill’s Criteria - January 3rd, 2010 [January 3rd, 2010]
- The life cycle of translational research - January 10th, 2010 [January 10th, 2010]
- The anti-vaccine movement strikes back against Dr. Paul Offit - January 10th, 2010 [January 10th, 2010]
- Osteoporosis Drugs: Good Medicine or Big Pharma Scam? - January 10th, 2010 [January 10th, 2010]
- Acupuncture for Hot Flashes - January 10th, 2010 [January 10th, 2010]
- The case for neonatal circumcision - January 10th, 2010 [January 10th, 2010]
- A victory for science-based medicine - January 10th, 2010 [January 10th, 2010]
- James Ray and testosterone replacement therapy (TRT) - January 10th, 2010 [January 10th, 2010]
- The Water Cure: Another Example of Self Deception and the “Lone Genius” - January 12th, 2010 [January 12th, 2010]
- Be careful what you wish for, Dr. Dossey, you just might get it - January 13th, 2010 [January 13th, 2010]
- You. You. Who are you calling a You You? - January 15th, 2010 [January 15th, 2010]
- The War on Salt - January 16th, 2010 [January 16th, 2010]
- Is breech vaginal delivery safe? - January 16th, 2010 [January 16th, 2010]