Japan’s Pharmaceutical Affairs Law (PAL)
Recent years have seen an expansion of medical research and development activities in Japan, the United States, the European Union, Asia and other regions, as well as population aging and advanced technological innovation in fields such as biotechnology and new medical devices.
Terms such as drug lag and device lag in the medical field refer to the long time it takes to obtain approval for new medical developments in Japan in comparison with other countries. Many devices that have been approved and are widely used in other countries have not yet been approved in Japan, and in some cases, only devices from two or three device-generations ago are available.
However, in recent years, the environment surrounding the public administration of pharmaceutical affairs in Japan has changed radically. To combat the situation of delayed approval for medical developments, MHLW (Ministry of Health, Labour and Welfare) implemented a major revision of the Pharmaceutical Affairs Law (PAL) in 2002 and reformed the related approval and licensing system.
In 2003, a system for investigator-initiated trials was started, and the existing system for ensuring the safety of drugs and medical devices was enhanced by the introduction of biological product regulations.
In 2004, the introduction of marketing Business licenseswith the product license-holder function separated from the former manufacturing business license allowed companies to market drugs and medical devices without having to manufacture them directly. A requirement for QMS compliance (including overseas auditing) for marketing approval was also introduced, and new regulations on medical devices according to their classification were provided, including a new system for accreditation by registered notified bodies.
In April 2004, the Pharmaceuticals and Medical Devices Agency (PMDA) was established as an Incorporated Administrative Agency (IAA), and started to provide services related to functions for approval review of drugs and medical devices, consulting services such as clinical studies and GCP auditing with the aim of ensuring the safety and efficacy of drugs and medical devices in Japan.
Despite a period of transition and some initial confusion with the system, the change has improved the efficiency of the review system by delegating the review and certification processes to external organizations (i.e., registered certification bodies) for many widely used Class II devices such as endoscopes and ultrasound diagnostic systems. This delegation conforms to certification guidelines based on international standards. MHLW is also in the process of establishing a set of approval criteria based on international standards in regard to medical devices for which clinical trial data are not required.
For an overseas company wishing to enter the Japanese market, it is essential to develop a regulatory strategy based on a solid understanding of its duties as a foreign manufacturer as well as the options available and the pros and cons of each.
The Japanese government’s announcement of several decisions on Pharmaceutical Affairs Law (PAL) revision
Japan has one of the fastest and most pronounced rates of aging in the world – a demographic trend that results in higher incidence rates of cancer, cardiovascular disorders and lifestyle-related diseases such as diabetes and hyperpiesia. Despite this background, in reality, new medical products in Japan are approved around 10 years later than in other countries. The complexity and difficulty of the Japanese regulatory environment is one of the major factors contributing to the issues of drug lag and device lag.
To address these issues, the Pharmaceutical Affairs Law (PAL) was dramatically revised in 2005. Although this improved the situation, the government decided to implement further revisions to address the current problems of drug lag/device lag. Manufacturers/applicants need to know about these changes and local regulations in order to obtain regulatory approval in a timely manner.
Japan MDC plays a cooperative role in work on such revisions with the government and related industrial groups. As a result, it is in a strong position to help applicants navigate the related registration process for medical devices and offer a variety of support services for product registration with its expert knowledge of trends in Japan’s regulatory environment.
Medical Device Industry News
May 17, 2012--(Boston Scientific News Releases)--
Boston Scientific Announces FDA Approval and U.S. Launch of EPIC™ Vascular Stent
Boston Scientific Corporation (NYSE: BSX) announces U.S. Food and Drug Administration approval and market launch of the Epic™ Vascular Self-Expanding Stent System. The Epic Stent is designed to open blocked arteries in patients with iliac artery stenosis, a form of peripheral vascular disease associated with severe leg pain caused by insufficient blood flow.
May 16, 2012--(Edwards Lifesciences Press Releases)--
Edwards SAPIEN XT Transcatheter Valve Continues to Achieve Positive Patient Outcomes in 94 Center Post-Approval Study
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that data from its post-approval study involving 94 European centers performing transcatheter aortic valve replacement (TAVR) demonstrated positive outcomes for high-risk patients treated with the Edwards SAPIEN XT transcatheter heart valve.
May 16, 2012--(Mauna Kea Technologies Press Releases)--
MAUNA KEA TECHNOLOGIES RECEIVES 510(k) CLEARANCE FOR PORTFOLIO OF SMALLER DIAMETER CELLVIZIO® MINIPROBES
Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), leader in the endomicroscopy market and developer of Cellvizio®, the world’s smallest microscope, announced today that the U.S. Food and Drug Administraton (FDA) has cleared a portolio of smaller Cellvizio Miniprobes.
May 16, 2012--(St.Jude Medical Press Releases)--
Renal Denervation Technology from St. Jude Medical Demonstrates Significant Reduction in Blood Pressure
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that preliminary data demonstrated the company’s EnligHTN™ renal denervation system was safe and effective for the treatment of resistant hypertension. The study demonstrated that on average patients with resistant hypertension experience a systolic blood pressure reduction of 28 points after 30 days.
May 15, 2012--(Abbott Press Releases)--
Abbott's XIENCE PRIME™ and XIENCE V® Drug Eluting Stents Receive Indication in Europe for Minimum Three-Month Duration of Dual Anti-Platelet Therapy
Abbott (NYSE: ABT) today announced that the XIENCE PRIME™ and the XIENCE V® Everolimus Eluting Coronary Stent Systems have received CE Mark in Europe for the use of dual anti-platelet therapy (DAPT) for at least three months after stent implantation in patients with coronary artery disease. This is the shortest duration of DAPT for any major drug eluting stent (DES) in Europe.
May 15, 2012--(Boston Scientific Press Releases)--
One-Year EVOLVE Trial Clinical Results Confirm Comparable Safety And Effectiveness Data Of The Boston Scientific SYNERGY™ Stent Versus PROMUS Element™ Platinum Chromium Stent
Boston Scientific Corporation (NYSE: BSX) announces that the SYNERGY™ Everolimus-Eluting Bioabsorbable Polymer-Coated Platinum Chromium Coronary Stent System demonstrated non-inferior results in treating de novo coronary artery lesions at one year compared to the PROMUS Element™ Everolimus-Eluting Platinum Chromium Stent System in the EVOLVE First Human Use Trial.
May 11, 2012--(Medtronic News Release)--
New Data From Landmark Study Shows Cost-Effectiveness of Medtronic Life-Saving CRT-D Therapy in Mildly Symptomatic Heart Failure Patients
Medtronic, Inc. (NYSE: MDT) today announced findings from an economic analysis of the landmark RAFT (Resynchronization / Defibrillation in Ambulatory Heart Failure Trial) trial demonstrating that cardiac resynchronization therapy with defibrillation (CRT-D) is a cost-effective treatment for mildly symptomatic heart failure patients.
May 11, 2012--(NinePoint Medical News)--
NinePoint Medical to Unveil NvisionVLE Imaging System at DDW 2012
NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, today announced that the company will preview its next-generation optical imaging technology, the NvisionVLE™ Imaging System, at Digestive Disease Week 2012 (DDW 2012), being held May 19 to 22 at the San Diego Convention Center in San Diego. NinePoint Medical will provide public demonstrations of the NvisionVLE Imaging System, which is designed to bridge the gap between diagnosis and disease treatment by enabling physicians and pathologists to evaluate high-resolution, volumetric images of organs and tissues in real time.
May 10, 2012--(BIOTRONIK Press Releases)--
FDA Approves BIOTRONIK Next Generation ICDs and CRT-Ds
BIOTRONIK, a leading manufacturer of innovative medical technology, has received FDA approval of its new Lumax 740 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds). Lumax 740 helps physicians monitor and treat their patients’ arrhythmias and heart failure under ever-changing medical conditions.
May 10, 2012--(Sorin Group Press Releases)--
SORIN GROUP ANNOUNCES FDA APPROVAL AND COMMERCIAL LAUNCH OF COMPLETE PORTFOLIO OF IMPLANTABLE HEART DEVICE LEADS
Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today at Heart Rhythm 2012, the Heart Rhythm Society’s 33rd Annual Scientific Sessions, FDA approval and commercial launch for a full portfolio of pacing, defibrillation and left ventricular leads.
May 10, 2012--(GE Healthcare Press Releases)--
GE Healthcare Introduces a New Version of Vscan
Today, GE Healthcare introduced a new version of its Vscan* pocket-sized visualization tool, developed to deliver imaging capabilities at the point-of-care. Based on feedback from current Vscan users, the new version features extended battery life, a more intuitive user interface, and enhanced reporting capabilities. This intuitive device provides a non-invasive look inside the body to help immediately visually validate what clinicians feel and hear during the physical exam.
May 09, 2012--(St. Jude Medical News Release)--
St. Jude Medical Announces FDA Approval of Smaller ICD with Physician Inspired Shape
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of its Ellipse™ implantable cardioverter defibrillator (ICD). Designed with feedback from more than 200 physicians from around the world, the Ellipse ICD offers physicians unique design advancements, resulting in the industry’s smallest high-energy ICD.
May 08, 2012--(St. Jude Medical News Release)--
St. Jude Medical Announces FDA Approval of Assura™ Implantable Defibrillators with Features That Reduce Inappropriate Shocks
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new implantable defibrillators feature SecureSense™ RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients with these devices.
May 07, 2012--(Boston Scientific News Release)--
Boston Scientific Announces FDA Approval and First U.S. Implant of New Devices To Treat Bradycardia
Boston Scientific Corporation (NYSE: BSX) announces U.S. Food and Drug Administration (FDA) approval and market launch of its INGENIO™ and ADVANTIO™ pacemakers and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-P). The first implant of the INGENIO pacemaker in the U.S. was performed on May 3 by Bruce L. Wilkoff, M.D., Director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic.
May 02, 2012--(Johnson & Johnson Press Release)--
Johnson & Johnson (China) Investment Ltd. Acquires Guangzhou Bioseal Biotech Co., Ltd.
Johnson & Johnson (China) Investment Ltd. today announced it has acquired Guangzhou Bioseal Biotech Co., Ltd. (Bioseal), a privately held biopharmaceutical company specializing in the design, development and commercialization of a porcine plasma-derived biologic product for controlling bleeding during surgery. The acquisition was completed after obtaining all necessary Chinese Government approvals. Financial terms of the transaction are not being disclosed.
May 01, 2012--(Teleflex News Release)--
Teleflex Acquires Innovative Technology for Lung Isolation Procedures
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, announced it has acquired the EZ-BlockerTM disposable catheter product line with a unique bifurcated distal end, a novel and patented bronchial blocker for lung isolation and one-lung ventilation. The acquisition is consistent with the company's strategy to invest in late-stage, innovative technology to support its future growth.
