JANUARY 2020 INDUSTRY NEWS
EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative is built on the success of and experience gained from a similar collaboration, the international active pharmaceutical ingredients (APIs) inspection programme. This collaboration will allow EMA, EU national authorities (France and the United Kingdom), the United States Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the World Health Organization (WHO) to share information on Good Manufacturing Practice (GMP) inspections of manufacturers of sterile medicines who are located outside the participating countries, and to organise joint inspections for manufacturing sites of common interest.
The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement actions signaled the Agency’s ongoing interest in ensuring GMP compliance overseas.
FDA Updates Compliance Guide on Pre-approval Inspections for Drugs
“Drug manufacturers looking to avoid Form 483s take note: the US Food and Drug Administration (FDA) has recently tweaked its compliance guide on pre-approval inspections, which according to one consultant will impact analytical procedures and data included in regulatory submissions. A pre-approval inspection is performed by FDA to ensure that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete. The front of the updated compliance guide, which was first released in September but which will not fully take effect until 16 September 2022, explains the changes: “Revision: Program revised to add instructions for potential official action indicated (pOAI) reporting responsibilities and to align with the Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) agreement Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.”
5 trends to watch at the FDA in 2020
“The Food and Drug Administration is one of America’s most closely scrutinized agencies, tasked as it is with guaranteeing the safety of both food and medicine. The political winds have demanded the FDA not erect too many barriers to the approval of new drugs, particularly those treating orphan diseases and terminal illnesses, and the agency’s response has been impressive.“
DECEMBER 2019 INDUSTRY NEWS
The IMDRF Cybersecurity Guidance: A Comprehensive Analysis
“Currently, cybersecurity guidelines for medical devices vary from country to country. In the United States, the U.S. Food and Drug Administration (FDA) has released two guidance documents aimed primarily at medical device manufacturers. Content for Premarket Submissions for Management of Cybersecurity in Medical Devices and Postmarket Management of Cybersecurity in Medical Devices — issued in 2014 (updated in 2018) and 2016, respectively — provide important information about what the FDA expects relevant to cybersecurity in premarket submissions and in postmarket management plans. These guidance documents have become the basis for regulatory guidance in several other countries. However, many countries have developed different guidelines or have not issued any guidance at all, creating significant confusion in the marketplace.“
Senate confirms Dr. Stephen Hahn as FDA commissioner
“The US Senate on Thursday confirmed Dr. Stephen Hahn to be the next commissioner of the US Food and Drug Administration. The Senate vote was 72 to 18. Hahn, 59, is a well-known radiation oncology expert and is the current chief medical executive of The University of Texas MD Anderson Cancer Center in Houston, where has been a professor of radiation oncology since January 2015. “Dr. Hahn can now get to work approving new life-saving drugs and devices, regulating tobacco and e-cigarettes, addressing the opioid crisis, ensuring pain patients can receive the medications they need and protecting our nation’s food supply,” Republican Sen. Lamar Alexander wrote in a Twitter post following the confirmation.”
Medical Device Tax Is History After Trump Signs Repeal
“The medical device industry hailed President Trump’s signing into law a bipartisan federal spending package that brings in an end to a tax the medical technology industry has been fighting against for the last decade. The 2.3% tax on medical device sales that is part of the Affordable Care Act has already been on temporary hiatus since the beginning of 2016, but was scheduled to return at the end of this year if Congress didn’t eliminate the tax or put it on hiatus once again. Medical device makers feared a major hit to their bottom lines, research budgets and jobs if Congress didn’t end or at least shelve the tax before the end of the year. A report released earlier this month from the Tax Foundation shows a return of the medical device tax would “would result in a decline of 21,390 full-time equivalent jobs and a reduction in GDP of $1.7 billion.”
NOVEMBER 2019 INDUSTRY NEWS
Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff: Draft Guidance
“Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft document. Submit electronic comments to https://www.regulations.gov. This document, 1 55 Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA 56 Staff, sets forth risk-based principles by which the Food and Drug Administration (FDA or Agency) 57 conducts ongoing postmarketing safety surveillance for human drug and biological products (biologics).”
ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry
“A recently released survey from the International Council on Harmonisation (ICH) shows pharmaceutical regulators and companies around the world are adopting and adhering to the council’s guidelines related to quality, safety and efficacy.
The survey of 32 pharmaceutical companies provided responses on 15 regulatory authorities, which included the founding ICH members: the European Medicines Agency, the US Food and Drug Administration, Japan’s MHLW/PMDA, Health Canada and Swissmedic, as well as other newcomers from Brazil, China, Singapore and South Korea, and observers from Malaysia, Russia, South Africa and Turkey.”
How software may be classified under medical device regulation guidance
“The new regulatory landscape on software medical devices that will apply under the new Regulations (Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/756 (In Vitro Diagnostic Regulation (IVDR)) as of 26 May 2020 and 26 May 2022 respectively, has been somewhat clarified by new guidance published by the European Commission’s Medical Devices Coordination Group (MDCG). Given that the Guidance has been the result of considerable work/ deliberations by the MDCG, due to the particularities of and fast pace of innovation in software as a medical device, one would expect more topics to have been addressed and perhaps in more depth. Still, this Guidance provides the first valuable insight into how software will be classified under the new Regulations, while more specific examples will continue to be included in the Borderline manual guidance.”
Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings
“The latest regulatory agenda for the US Food and Drug Administration (FDA) was released on Wednesday, announcing the delays of several proposed rulemakings, and one new but expected addition on the importation of prescription drugs.
On importation, the proposed rule, which has been under review at the Office of Management and Budget since the beginning of November and is expected to be released by January, would allow pharmacists and wholesalers to import prescription drugs from Canada if the imports pose no additional risks and will save money. The proposed rule is expected to have several key limitations (i.e. only facilities that also manufacture API for the FDA-approved version would be allowed) and exclusions (no costly biologics, drugs with a REMS or infused or injected drugs) that may raise questions about what drugs could be imported and how much could be saved.”
OCTOBER 2019 INDUSTRY NEWS
Understanding the FDA Form 483: A Q&A with NSF’s Maxine Fritz
“The FDA Form 483 is not an extensive list of all potential problems, but only those that inspectors can clearly identify as potential violations to FDA regulations. A detailed establishment inspection report (EIR) is written by the FDA inspector/inspection team that further outlines details of the company, its facilities, processes, quality systems, products, refusals, inspectional observations and discussion with management. The company should address these inspectional observations in a written response to the FDA following the inspection. The written response to the FDA 483 should outline the holistic improvements and corrective actions to be taken to remedy the observation and the timeline that it will take to complete them.
MDR/IVDR Guidance: MDCG Explains What’s Coming
“The European Commission’s Medical Device Coordination Group (MDCG) on Friday unveiled its plans for releasing almost 50 future guidance documents related to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the bulk of the new guidance coming on the oversight of notified bodies (NBs) and clinical investigations and evaluation (CIE).
The list also notes that much of the guidance will be endorsed by the MDCG later this year or in 2020, although for more than 20 guidance documents, the timing is to be decided.”
FDA is smashing the status quo for regulatory science
“Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality,” may have sounded like another bland and boring exercise in regulatory rhetoric. But it actually signals a revolutionary shift in regulatory velocity. Changes in the FDA’s Office of New Drugs (OND) will create enhanced review zones that cross disease areas and divisions to maximize access to more focused and innovative areas of regulatory expertise. These changes will, among other things, increase the number of OND offices overseeing product reviews from six to eight and increase the number of specific clinical review divisions from 19 to 27. The rationale is to make the FDA more efficient and help it better understand the diseases that are the aim of treatment by the drugs being evaluated for approval.“
FDA Toughens Enforcement of Homeopathic Products
“FDA recently announced that it was taking two significant actions with respect to products marketed as homeopathic drugs, suggesting that increased enforcement related to these products is imminent. Homeopathy is a form of alternative medicine that is based on the idea that illnesses and their symptoms can be treated by small doses of ingredients that produce similar symptoms in healthy people.”
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