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    Euro Roundup: EMA clarifies label flexibility for COVID vaccines

    COVID-19 vaccines may be distributed in English-language only  packaging in Europe under temporary measures designed to ensure speedy deployment of vaccines against the coronavirus, according to a question-and answer-document published by the European Medicines Agency (EMA).   Based on principles set out in a statement from the European Commission, EMA will permit manufacturers to provide COVID-19 vaccines with outer and immediate packaging that only carries text in ...
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    Asia-Pacific Roundup: PMDA puts patients at heart of push for Japan-first approvals

    The head of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has outlined plans to get patients and the public more involved in product development. Chief executive Fujiwara Yasuhiro framed the initiative as part of an effort to increase the number of products that come to market in Japan before being authorized overseas.   Yasuhiro took over as chief executive of PMDA in April 2019. The following month, PMDA established the Patient Centricity Working Group to...
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    Asia-Pacific Roundup: India clarifies ‘Make in India’ medical device order

    Guidance from the Indian Department of Pharmaceuticals clarifies how companies can take advantage of an order intended to encourage the use of local suppliers of medical devices. The order , published in September, created two groups of local suppliers that will be eligible to bid on many contract, Class I and Class II.  Class I suppliers will win the full quantity of any contract for which they are the lowest bidder, while Class II or non-local suppliers who submit the...
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    Euro Roundup: EDQM posts batch control guidelines for COVID vaccines

    The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released guidelines on the tests that laboratories need to perform as part of the independent control of COVID-19 vaccines.   Official Medicines Control Laboratories (OMCLs) will test the potency and other characteristics of COVID-19 vaccines distributed in the European Union and review batch release protocols from the manufacturers. The work, which the laboratories will undertake as part of ...
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    Asia-Pacific Roundup: Quality concerns drive TGA face mask review

    Australia’s Therapeutic Goods Administration (TGA) has begun a postmarket review of face masks amid concerns some do not perform as intended or meet the requirements for inclusion in the Australian Register of Therapeutic Goods (ARTG).   The review will assess if face masks in the ARTG, including devices in the National Medical Stockpile, meet the regulatory requirements and perform as intended. TGA is assessing compliance with the standards for Exhalation Resistance, ...
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    Euro Roundup: Swissmedic allows remote source data verification

    Pandemic-related remote source data verification for clinical trials should focus on critical data, such as the primary efficacy endpoint and key safety measures, according to updated guidance from the Swiss Agency for Therapeutic Products (Swissmedic).   Early in the pandemic, the European Commission began allowing clinical trials of COVID-19 products and pivotal studies of treatments for serious or life-threatening conditions to use remote source data verification (S...
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    Asia-Pacific Roundup: Japan’s PMDA asks physicians to cooperate with adverse event relief system

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has called for physicians to cooperate with its Relief System for Adverse Drug Reactions. The system, which was set up in 1980, is designed to ensure prompt relief for people who suffer adverse health effects due to properly used drugs.   Over its first 39 years in use, the system granted relief to almost 25,000 cases using contributions that marketing authorization holders provided to fulfill some of their soci...
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    Euro Roundup: EDQM advises on COVID viral vectored vaccines

    The European Directorate for the Quality of Medicines (EDQM) has published advice on developing COVID-19 vaccines using viral vector platforms. The text covers analytical strategies for recombinant viral vectored vaccines such as AstraZeneca’s AZD1222 and Johnson & Johnson’s JNJ-78436735 (also known as Ad26.COV2.S).   Viral vectored vaccines are a relatively unproven and untested modality. Yet, the need to act quickly in response to the coronavirus outbreak means viral...
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    Asia-Pacific Roundup: TGA cancels three breast implants

    Australia’s Therapeutic Goods Administration (TGA) has cancelled three breast implants after their sponsors failed to demonstrate the safety and performance of the devices.   TGA suspended the devices from JT Medical and Euro Implants a year ago in response to evidence of a link between certain implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). At that time, TGA gave JT Medical and Euro Implants and two other sponsors six months to share ...
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    Euro Convergence: EMA makes case for multi-stakeholder response to emerging challenges

    The idea that regulatory agencies can come up with solutions in isolation is “very dangerous” and underscores the need for multi-stakeholder responses to emerging challenges, said Anthony Humphreys, of the European Medicines Agency (EMA), at the Euro Convergence 2020 virtual meeting.   Speaking during a session on supporting innovation, Humphreys, head of EMA’s regulatory science and innovation taskforce, set out the importance of gathering the views of other stakehold...
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    Euro Roundup: MHRA shares post-Brexit assessment routes, variations guidances

    New guidances from the Medicines and Healthcare products Regulatory Agency (MHRA) address new assessment routes, marketing variation processes and rules on converting Community Marketing Authorisations (CAPs) that will apply to products sold in the United Kingdom post-Brexit.   The new assessment routes include an accelerated assessment pathway that, like its EMA equivalent, will reduce the regulatory review timeline to 150 days, according to the guidance.   The pa...
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    Euro Convergence: Pragmatic approaches to data collection needed to meet MDR

    Manufacturers have a narrowing window of opportunity during which to find pragmatic ways for gathering post-market data to support continued use of products under the Medical Device Regulation (MDR), according to experts who spoke at the Euro Convergence 2020 virtual meeting.   The outgoing Medical Device Directive (MDD) contains scant information on post-market surveillance (PMS) and post-market clinical follow-up (PMCF). MDD contains two uses of the term PMS, creatin...