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    EC Adds Six New Products to Borderline and Classification Manual

    The European Commission (EC) added six new medical and nonmedical products to its manual on borderline and classification cases based on the regulatory framework for medical devices.   EC’s manual is intended to serve as a tool to help manufacturers achieve time and cost savings by providing regularly updated clarifications. These policy updates clarify whether a product would be considered a medical device consistent with the European Medical Device Vigilance System (...
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    EU MDR/IVDR: European Commissioner Looks to Quash Transition Concerns

    The road to the new European medical device and in vitro diagnostic regulations (MDR/IVDR) has raised many concerns, but a European Commissioner recently attempted to ease some of these concerns during a plenary session of the European Parliament.   “Many of you said that I am optimistic and calm,” EU Commissioner for Internal Market, Industry, Entrepreneurship and small and medium-sized enterprises (SMEs) Elżbieta Bieńkowska said to a crowd of EU political group...
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    EU Releases Working Plan to Implement MDR/IVDR

    The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations (MDR and IVDR). The EC’s working plan describes the legal basis, the expected adoption timelines and the current status of 12 implementing acts under MDR/IVDR and 12 other actions or initiatives. The only implementing act in the roadmap that has been completed so far involves the defined scope of notified body (NB) de...
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    New Law to Boost EU-level Cooperation on Health Tech Assessments

    In a boost for health technology assessments (HTA), the European Parliament recently adopted a new law that allows for greater cooperation among EU member states.   The law on HTAs specifically seeks to minimize duplicate assessments on new medicines and medical devices with the goal of removing unnecessary barriers to patient access and reducing administrative burden on industry. Following its 3 October adoption , the law was well-received by MedTech Europe as ...
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    EMA Sartan Investigation Flags Aurobindo Pharma, Raises Zhejiang Huahai Oversight

    The European Medicines Agency (EMA) announced Monday low levels of a probable human carcinogen have been detected in a third sartan made the second India-based company—Aurobindo Pharma—to have been linked to the international valsartan scandal.   The notice follows on the heels of the EMA’s decision to extend its review to include medicines containing an additional four sartans, with the one impacted by the suspension of Aurobindo Pharma’s European certificate of s...
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    EMA to Raise MAH and Applicant Fees by 1.7% in April

    As part of the European Medicines Agency’s (EMA) alignment with the inflation rate, the agency announced on Tuesday that general, non-pharmacovigilance for applicants and marketing authorization holders are increasing by 1.7% on 1 April 2018. “All applications received by 31 March will be charged the current fee and reduction rates. Applications received after that date will be charged the adjusted fees,” EMA said. “For scientific advice and protocol assistance, the cut...
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    WHO: 1 in 10 Medicines in Developing Countries is Substandard or Fake

    The findings come from two new reports, one looking at data collected from WHO's Global Surveillance and Monitoring System over the last four years and another that pooled data from 100 literature reviews to examine the public health and socioeconomic impact of substandard and falsified medicines. Based on the reports, WHO says that as many as one in 10 medicines sold in low- and middle-income countries is either substandard or falsified, at a cost to the global health s...
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    Asia Regulatory Roundup: India Introduces Tougher Regulations on Homeopathic Medicines (20 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australian Generic Medicine Work-Sharing Trial Misses Completion Target A work-sharing group involving Australian regulators has reported the results of its first collaborative assessment of a generic medicine. The review of the filing took about nine months, four months longer than the collaborators had targeted at the start of the project. Officials from Australia’...
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    FDA Begins Adding Suffixes to Newly Approved Biologics' Names

    • 17 November 2017
    The US Food and Drug Administration (FDA) this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in policy from only adding the suffixes to biosimilars' nonproprietary names since 2015. The first additions of the meaningless suffixes came for Thursday's approval of Roche's Hemlibra (emicizumab-kxwh), one of the first new medicines in nearly two decades to treat people with hemophilia A, ...
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    EMA Drafts Guideline on RSV Treatments and Vaccines

    The European Medicines Agency (EMA) on Tuesday released for consultation a new guideline to help companies develop new medicines, direct-acting antiviral agents, monoclonal antibodies and vaccines to treat and prevent infections caused by the respiratory syncytial virus (RSV). According to EMA, RSV is a common respiratory virus that usually causes mild, cold-like symptoms that most recover from, though RSV can be serious, especially in infants and older adults. Curr...
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    UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments

    Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopeial standards for biologics, according to a report issued Monday. In general, MHRA says the responses supported the value of standardization, and found that areas where standards could add value included providing guidance and ensuring consistency for product characterizat...
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    First Implementing Act Under EU MDR, IVDR Open for Consultation

    The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday. Implementing acts allow the commission to tease out the intricacies of the legislation and this first one is related to the Notified Body product codes for medical devices and IVDs. The codes, included in the implementing regulation's annexes, are used to categorize the fields of expertise of the NBs ...