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


Medical devices regulation countdown

“Currently, there are more than 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Robust regulation that ensures a supply of safe devices, and allows monitoring of the introduction and use of medical devices, is essential. The new Medical Device Regulation (EU) 2017/745 was published in the Official Journal of the European Union and came into force on May 5, 2017, replacing two existing Directives…The new regulations apply after a transitional period. Namely, three years after entry into force of Regulation (EU) 2017/745 on medical devices (May 26, 2020), and five years after entry into force (May 26, 2022) of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices.”

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Draft guidance on CDER’s program to recognize standards in pharmaceutical quality

“A draft guidance has been made available for industry entitled CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. This guidance describes a proposed program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. This program, once established, should facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition. This informal program will help streamline the compilation and assessment of marketing applications for products regulated by CDER.”

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Canada Steers Away From Using Suffixes in Biologics’ Names

“Canada has decided to not use suffixes in the non-proprietary names of biologics or biosimilars, making the US the only country in the world to use such suffixes. “Following internal and external stakeholder consultations and analysis of related issues, Health Canada has decided that biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix,” a notice to stakeholders said. “Both the brand name and non-proprietary name should be used throughout the medication use process so that biologics that share the same non-proprietary name can be distinguished by their unique brand names.”

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What are Brexit contingency plans for pharmaceutical industry?

Brexit poses a big threat to pharmaceutical research and manufacturing in the UK, the industry has said, potentially driving up manufacturing costs and deterring future investment. AstraZeneca and other companies have frozen all manufacturing investments. Britain’s second-biggest drugmaker decided to halt further investments at its Macclesfield site in the summer of 2017. Its chairman, Leif Johansson, has said the UK needs to make sure it “does not become an isolated island in the middle of the Atlantic Ocean.” David Jefferys, a senior executive at the European arm of the Japanese company Eisai, which makes treatments for Alzheimer’s disease, epilepsy and breast cancer, told the Guardian: “Nobody likes uncertainty. We are not making any new investments in the UK until there is clarity.”

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cGMPCDER Priorities for 2019: Opioids, Quality, Safety, and Innovation

“FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality. It will be a challenge for FDA to match or exceed its success this past year in approving record numbers of innovative and generic drugs. These achievements reflect the ability of biopharma companies to capitalize on important advances in science, as well as strong support from regulators in clarifying requirements and R&D policies. While the Center for Drug Evaluation and Research (CDER) will strive to further enhance its operations, it also will support initiatives to ensure that all medicines are safe, effective, and of high quality.”


What’s in a connected medical device? Cybersecurity regulators want to know

“FDA is mulling a requirement that device makers draw up a list of internal hardware and software components, key information which could help providers more quickly respond to cyberattacks. With connected medical devices becoming ubiquitous, hospitals face risk of cyberattacks that could disrupt services and cause widespread patient harm. Device makers, though, say such a list raises big questions — from what the controls are around sharing and maintenance of these lists, to how detailed they should be and the impact on time to market.”


IMDRF Gains Ground with Plans for a Medical Device Single Review Program

“Regulators participating in the International Medical Device Regulators Forum (IMDRF) recently convened in Tokyo to discuss a medical device single review program (MDSRP). The meeting involved the IMDRF good regulatory review practices (GRRP) working group, which took up medical device premarket reviews as a new work item after the September 2018 management committee meeting in Beijing. An “important document” for MDSRP was discussed and “unanimously recognized” by the participants, according to China’s Center for Medical Device Evaluation (CMDE).”


The problem with EU’s new medical device rule

“The EU’s rush to clamp down on faulty medical devices is backfiring.  With global regulators accused of failing to protect millions of patients from poorly tested medical implants by the “Implant Files” investigations by the International Consortium of Investigative Journalists, the EU is pointing to sweeping laws already adopted to show it’s on the case.”



House Floats Five Year Extension of Medical Device Tax

“The widely unpopular medical device excise tax would be delayed for another five years under a tax relief package introduced by the US House Ways and Means Committee on Monday. The 2.3% levy on the sale of prescribed medical devices was in effect between 2012 and 2014 after it was enacted through the Affordable Care Act in 2010, but the pushback from industry has led to several moratoriums. It received a 2-year delay extension earlier this year as part of a continuing resolution.”

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pharmaceuticalStatement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice

“Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Overseeing the quality and safety of pharmaceutical manufacturing is key to these efforts. With the emergence of new markets, supply chains are more complex. Drug production and testing operations have also become more computerized. These changes represent new opportunities and challenges. Having clear guidelines for companies on how to prevent product quality issues is an important step to protecting patient safety and preventing drug shortages of critical medicines. To meet these challenges, our policies and guidance must also evolve to ensure that quality standards are maintained, and to assist companies in building a culture of quality. To that end, one area we’ve focused new attention on in recent years is data integrity. Our goal is to ensure that the data associated with drug manufacturing are complete, consistent, and accurate, and therefore reliable.”

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FDAFDA Issues Final Rule on Medical Device Classifications

“The U.S. Food and Drug Administration (FDA) has published a final rule that brings its medical device classification requirements in line with current medical device regulations. Published earlier this week in the Federal Register, the final rule, entitled “Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures,” updates and clarifies Part 860 (Medical Device Classification Procedures) of Title 21 of the Code of Federal Regulations so that they are consistent with the provisions of the FDA Safety and Innovation Act (FDASIA). The FDASIA came into effect in 2012 and established new processes for premarket approval (PMA) applications and for the classification and reclassification of medical devices.”

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A ‘no deal’ Brexit could affect UK-EU pharma trade for six months, says UK gov’t

 By Flora Southey: Access to medicines across the English Channel could be ‘significantly’ reduced for up to six months, if the UK leaves the EU without a deal, according to MP.