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  • Regulatory NewsRegulatory News

    EU foresees reenergized clinical trial sector as new regulations take effect

    The delayed Clinical Trials Regulation (CTR) is set to take effect on Monday, 31 January, marking a milestone in the European Union’s attempt to improve transparency and boost the amount of human research that takes place in the region.   Currently, sponsors must file clinical trial applications to national regulators and ethics committees in each country that they want to include in their studies, then cope with multiple processes for registering their studies and pos...
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    Asia-Pacific Roundup: TGA seeks feedback on adverse event data

    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into how to improve access to medicine adverse event data. The agency is proposing to enable sponsors to view and export such data from its systems.   Currently, sponsors cannot automatically view or export de-identified adverse event data held in TGA systems; instead, they must manually search the public Database of Adverse Event Notifications - Medicines or email TGA. After receiving a reque...
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    Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation

    The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in the UK. MHRA is seeking feedback on tens of proposals intended to streamline processes and remove unnecessary burdens to clinical trial sponsors.   Having left the European Union before the implementation of the Clinical Trials Regulation, the UK is free to plot its own course as it seeks to establish itself as the best place to rese...
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    Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests

    Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance on advertising the tests and issuing a fine in relation to an allegation of unlawful importation.   The Q&A is focused on point-of-care tests, as opposed to the home-use products that became available in Australia late last year, while...
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    Euro Roundup: EDQM pushes forward with ‘CEP of the future’ after positive feedback

    The European Directorate for the Quality of Medicines (EDQM) will spend the first half of 2022 designing the Certificate of Suitability (CEP) after a consultation revealed support for its plan to revise the content and layout document.   Companies working with active substances, raw materials, starting materials or excipients that are the subject of a European Pharmacopoeia monograph can request a CEP from EDQM and include the text in their applications instead of cert...
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    European Commission creates rules for allocating clinical trial safety oversight

    The European Commission has published an implementing regulation that details the process for picking a member state to assess information on suspected unexpected serious adverse reactions and describes their role in screening for safety signals in clinical trials.   European law requires clinical trial sponsors to report suspected unexpected serious adverse reactions to investigational medicinal products, as well as annual safety reports, to the European Medicines Age...
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    Asia-Pacific Roundup: TGA seeks feedback on planned adoption of 19 international guidance documents

    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation about plans to adopt 19 international scientific guidelines. TGA wants to know whether stakeholders support the adoption of the European Medicines Agency (EMA) and International Council for Harmonisation (ICH) documents.   As part of its effort to closely align its regulatory approaches with EMA, ICH and the US Food and Drug Administration, TGA has adopted around 370 international scientific g...
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    Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the coordinated assessment pathway it is piloting to streamline the review of clinical investigations involving medical devices.   MHRA and the Health Research Authority (HRA), which makes sure research is ethically reviewed and approved, are working together to test the pathway. The two organizations are sharing information on their assessments of medical device clinical investi...
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    Asia-Pacific Roundup: TGA asks drugmakers to mitigate cybersecurity weakness amid ‘active malicious exploitation’

    Australia’s Therapeutic Goods Administration (TGA) has asked drugmakers and other stakeholders to detect and mitigate a cybersecurity vulnerability. TGA made the request after learning of “widespread and active malicious exploitation” of the critical vulnerability in an open-source logging library.   Developers across multiple industries use Apache's Log4j to track activity in their software applications and online services. The log serves as a journal of activity that...
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    Euro Roundup: Commission acts to stop Brexit from disrupting supply of medicines

    The European Commission has set out how it plans to stop Brexit from disrupting the supply of drugs in certain markets, most notably Northern Ireland. The plan builds on the proposal the Commission made in October as part of the multiple rounds of negotiations with the United Kingdom.   Under parts of the Brexit agreement designed to avoid a hard border on Ireland, Northern Ireland, which is part of the UK, is subject to European Union regulations. The situation has ...
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    Asia-Pacific Roundup: New Zealand probes role of Pfizer’s COVID-19 vaccine, myocarditis in three deaths

    Authorities in New Zealand are reviewing whether the Pfizer-BioNTech COVID-19 vaccine played a role in the deaths of three people who died with potential myocarditis in the period following vaccination.   Myocarditis, inflammation of the heart muscle, is a rare reaction to vaccination with Pfizer’s Comirnaty and Moderna’s Spikevax. However, myocarditis can occur in response to viral infection, too, and the New Zealand COVID-19 Vaccine Independent Safety Monitoring Boar...
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    Euro Roundup: EMA backs mix-and-match approach to COVID-19 vaccine courses and boosters

    The European Medicines Agency (EMA) has backed the use of a mix-and-match approach to COVID-19 vaccine initial courses and booster shots, for example two AstraZeneca jabs followed by a booster dose of the Pfizer-BioNTech vaccine.   Many countries in the European Union and beyond are already allowing people to receive two different COVID-19 vaccines for their first and second doses and, in particular, booster shots that differ from their initial course. The heterologous...