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PATHWISE INDUSTRY NEWS

Read important industry news with the latest articles on life sciences, manufacturing, and regulatory issues. 

AUGUST 2019 INDUSTRY NEWS

Medical Device

Boosting Medical Device Quality and Profitability via a Common Product Model

“Medical device manufacturers face hurdles taller than ever in getting high-quality products to market faster, cost-effectively. Hindering their efforts are not just external factors but also internal processes for designing and producing those products. That is why it’s time for medical device companies to adopt a design-to-manufacturing environment where designers, engineering, and production teams are synchronized on a common product model. This approach improves both product quality and profitability by reducing errors in production while increasing yield rates.”

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Industry backs Australia’s device identifier plan with caveats

When Australia’s Therapeutic Goods Administration ran the UDI consultation at the start of the year, it sought to gather views on the merits of introducing a system it thinks it will improve outcomes, including patient safety. The response to the consultation suggests the creation of a UDI system will go ahead. TGA found a “strong consensus across all stakeholder groups for the need to introduce the UDI system,” leading it to move forward with the development of legislation that will facilitate the work.

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Compliance Training

Which GMPs for the cannabis industry? Pharmaceutical, food, or dietary supplement

“As with all molecular entities—whether chemical, botanical, or food-derived—FDA has one main focus: to ensure the safety, identity, purity and quality, and intended use of the ingredient is suitable for human and animal use. The use, dependent on the label claim and other regulatory considerations, can be categorized as a cosmetic, drug, food ingredient, or dietary supplement. Following a standard for manufacturing is the end result of implementing regulatory and quality considerations.​”

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Changing  3 More Years: US calls for delay on the implementation of EUMDR/IVDR

The US highlighted what it believes to be the main issues surrounding the implementation of these regulations in a statement to the World Trade Organisation committee on technical barriers to trade: “Our industry is worried about their continued access to the EU’s USD 125 billion medical device market, 20 billion USD of which is supplied by US products. To date the European Commission (EC) has designated two Notified Bodies (NBs) – BSI UK and TUV SUD against MDR and none against IVDR. Additionally, only one regulation that has been put forward has been adopted so far; the EC issued the draft implementing regulation on the common specifications for the reprocessing of single-use medical devices in accordance with the MDR last month.

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MDSAP – History and Advantages

“A few years ago, the U.S. Food and Drug Administration (FDA) realized there was no hope of achieving the legislated mandate of inspecting every Class II and Class III medical device manufacturer every two years. Congress would not provide the finances to hire enough investigators to perform those routine quality system inspections, in addition to required premarket approval (PMA) inspections, clinical trial (BIMO) inspections, and any recall or other enforcement inspections.

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JULY 2019 INDUSTRY NEWS

Changing Global Regulatory Landscape and Strategy for Drug and Device Operations

“Feature articles in July explored regulatory operations for drugs and devices. Topics included FDA and EU differences in cleanroom specifications, EU accelerated pathway programs, and data requirements for biosimilars versus the reference medicine. Other articles covered India’s new drug and clinical trial rules, China’s new guidance on regulatory inspection and analytical testing documentation, and medical device cybersecurity.”

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EU MDR: Changing World of Classification

“The EU MDR is shaking up the medical device industry and classification rules have not been left untouched. In spite of this, a critical misunderstanding threatens Class I device manufacturers: As the end of the Medical Device Regulation’s (MDR) transition period, set for May 26, 2020, steadily beckons, there is a mistaken belief that that the need to comply with the EU MDR only applies to businesses manufacturing higher risk devices. In reality, Class I manufacturers are under just as much pressure as their peers who are making products in higher classes and should be acting swiftly to ensure that they confirm compliance with the new regulation or risk losing the ability to continue to sell their products in the EU.”

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Australia on watch for possible EU notified body shortage

“Australia’s Therapeutic Goods Administration (TGA) on Friday said it is aware of industry concern about whether a sufficient number of notified bodies will be designated under the new European Union Medical Device Regulation in time for the May 2020 effective date. The Australian regulator said it is monitoring the situation and will consider the impact on manufacturers seeking certification for new products or looking to maintain existing certification.”

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The U.S.-China trade war: Here’s what it means for medical device industry suppliers

“The U.S.-China trade war is certainly affecting where U.S. medical device companies decide to make their products. But don’t expect a bunch of manufacturing to come back to the United States. They are looking at what I would call ‘right-shoring,’” Freudenberg Medical CEO Max Kley said of his company’s medtech customers. For 12 years, Freudenberg (Carpinteria, Calif.) has had a plant in Shenzhen, China, just outside Hong Kong, where about 150 workers are engaged in thermoplastic and silicone injection molding and assembly of finished devices.”

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JUNE 2019 INDUSTRY NEWS

FDAFDA Releases 20 Years of Data on Medical Device Adverse Event Reports

“The US Food and Drug Administration (FDA) recently ended its Alternative Summary Reporting (ASR) program for medical devices, revoked the related exemptions and on Friday made available on its website all adverse event reports received under ASR exemptions from 1999 to 2019.”

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Time ManagementEuropean Health Ministers Fight to Postpone Medical Device Safety Laws

“German and Irish health ministers are leading calls for key elements of new European safety laws on medical devices to be effectively postponed, arguing that a lack of readiness among regulators risks creating shortages of vital implants and surgical equipment. Legislation on the licensing and monitoring of medical devices was passed in 2017 and is due to come into effect in May next year. But many health ministers now believe that Europe’s complex, part-privatized regulatory regime — which they were unwilling to scrap — has failed to prepare itself for the new set of rules.”

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Combination Products and MDR: EMA Offers New Draft Guidance

“With a focus on drug-device combination products, the European Medicines Agency (EMA) on Monday issued its second draft guideline as part of a series related to the EU’s medical device regulation (MDR). The draft guideline covers the documentation expected for drug-device combinations (DDCs) in the quality part of the dossier for a marketing authorisation application (MAA). DDCs falling within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately.”

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US FDA-EMA Mutual Recognition: Two down, Two to go. 

 By Ben Hargreaves

Luxembourg and the Netherlands added to the US FDA-EMA mutual recognition agreement, which leaves just Germany and Slovakia to be verified.

HTTPS://WWW.IN-PHARMATECHNOLOGIST.COM/ARTICLE/2019/06/17/TWO-COUNTRIES-ADDED-TO-FDA-EMA-MUTUAL-RECOGNITION

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MAY 2019 INDUSTRY NEWS

FDAFDA finalizes guidance to spur biosimilar availability

“The Food and Drug Administration on Friday gave clear suggestions for drugmakers to make it easier for patients to obtain biosimilars, treating them similarly to generic drugs.In the final guidance, FDA gave drugmakers some clarity on the studies they need to show their biosimilar is interchangeable with a biologic. While federal law created a pathway for interchangeability, drug companies have been seeking greater guidance from the agency. Healthcare providers have called on the Trump administration and Congress to do more to increase availability of biosimilars. Biologics can cost hundreds of thousands of dollars for chronic conditions.”

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TÜV Süd becomes second Notified Body to European MDR

“TÜV Süd is now the second Notified Body designated to issue CE Mark certifications under the upcoming European Medical Devices Regulation (MDR).TÜV Süd’s designation covers all Notified Body Operations Group (NBOG) scope codes, but with some minor limitations…”

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IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

“In a new proposal to harmonize regulatory pathways for personalized medical devices, the International Medical Device Regulators Forum (IMDRF) is looking to crack down on the “questionable use of custom-made device exemptions” that some countries have been noticing. The IMDRF personalized medical devices working group (WG) makes note of technology’s evolution, which has allowed products to be targeted to an individual, as well as the ways in which custom-made devices have been exempted from certain regulations.”

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FDA highlights manufacturing quality efforts after recalls, regulatory criticism

“The FDA has faced scrutiny in recent months over a series of heart drug recalls and Bloomberg articles critical of the agency’s oversight process. Regulatory officials in February took the unusual step of defending their practices in a public statement. Much of the scrutiny has focused on drugs coming from India and China, the countries with the biggest number of pharmaceutical manufacturing sites for the U.S. market — aside from the U.S. itself. Indian sites accounts for 12% , while Chinese plants make up 11% of the total, according to the FDA’s latest report.”

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APRIL 2019 INDUSTRY NEWS

Top 5 issues for medical device risk management and design controls

“Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety. Risk/Benefit analysis is required in clause 6.5 of ISO 14971, but there is very little guidance on what is expected.  How do risk/benefit analyses impact design controls?”

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FDA’s Efforts to Advance the Development of Biologics

“The safety and efficacy of the biological products regulated by the FDA are inextricably linked to the quality and consistency of their manufacturing. This is as true now as it was when the Biologics Control Act of 1902 was enacted. Over a century of experience has informed our development of a holistic approach to the development and regulation of these products, from facilitating preclinical development to clinical development and on to post-market surveillance. This approach acknowledges the critical link between quality manufacturing and controls and the safety and efficacy of the products. To put it simply, for patients and the public to benefit from biological products, they must be made well.”

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Medical DeviceWhat you need to know about reusable devices and Europe’s MDR

“The introduction of MDR is putting increased emphasis on the roles that robust data and complete evaluations play in ensuring medical device safety. All devices, including Class I reusable devices (Class Ir), must meet the new guidelines or risk being excluded from the market.”

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EMA Officials Debate Going Beyond Safe and Effective Determinations for New Drugs

“In the US and Europe, drug regulators approve new drugs based on whether the benefits of the new product outweigh the risks. But neither of the regulators consider if such new drugs are superior to drugs currently marketed. Now, three senior officials at the European Medicines Agency (EMA) explain how an added therapeutic benefit criterion or head-to-head comparisons could help to drive more innovative therapies.”

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MARCH 2019 INDUSTRY NEWS

Dutch regulators weigh in on no-deal Brexit impact for medical device companies

“The United Kingdom (UK) may leave the European Union (EU) on 29 March 2019. The draft agreement on Brexit has not yet been ratified by the UK and the EU parliaments. The Netherlands and the EU are therefore still preparing for various scenarios. One of those scenarios is that no agreement is reached (a ‘no deal’ scenario). In case of a no deal Brexit, existing legislation concerning medical devices and in-vitro diagnostics will no longer be applicable to the UK as of the withdrawal date at which the UK leaves the EU. The EU legislation does not change, but companies that are based in the UK or that distribute their devices via the UK to the EU must adapt to the new situation in which the UK will become a third, non-EU country.”

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FDAFDA Tightening Regulatory Requirements For Some Medical Devices

“There’s no doubt that surgically implanted medical devices can improve lives. Hip and knee replacements can help people regain their mobility. Drug pumps can deliver doses of pain-relieving medicine on demand. And metal rods can stabilize spines and broken bones. But implanted devices can also do serious damage, as happened to Mechel Keel, who lives in Owosso, Mich. To fix her leaky bladder, an OB-GYN stitched a flexible mesh strap inside her pelvis in 2004. But within months the mesh hardened and started cutting her insides. The pain kept her from returning to her job as a hairdresser. The injuries and scar tissue that developed required multiple surgeries to correct and also resulted in chronic infections.

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cGMP

CDER Guidance Agenda for 2019: What’s Coming

“The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue almost 100 new draft and revised draft guidance documents spanning 15 different categories, from biosimilars to clinical pharmacology to drug safety, in 2019. The bulk of the guidance documents are contained in three categories: clinical/medical, pharmaceutical quality/CMC and procedural.”

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Harvard to Offer Free Online Course on Pharma Controversies

“Beginning 26 March, three professors at Harvard Medical School will begin offering a new free online course on controversial topics related to FDA, prescription drug prices, off-label marketing and other programs like the priority review voucher and Orphan Drug Act. The course will also cover topics such as the safety evaluation of prescription drugs using real world data, topics stirring debate over the scope of FDA regulation, such as with dietary supplements, special classes of prescription drugs and “right to try” laws.

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pharmaceutical

Issues of quality in pharmerging countries ‘more spoken about than real’

 By Ben Hargreaves

There is a common and often unchallenged perception that manufacturing quality standards in pharmerging countries are worrisome, but Lee Newton of Lonza argues this is not the reality.

HTTPS://WWW.IN-PHARMATECHNOLOGIST.COM/ARTICLE/2019/03/20/LONZA-ON-MANUFACTURING-IN-PHARMERGING-COUNT