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  • Regulatory NewsRegulatory News

    Euro Roundup: MEPs seek more power for EMA to address shortages

    Members of the European Parliament (MEPs) have voted overwhelmingly to give the European Medicines Agency (EMA) “a broader mandate and increased resources” to address supply disruptions from shortages of medicines.   The text, which MEPs adopted by 663-23, with 10 abstentions, calls for the European Commission and EU member states to address drug shortages from multiple angles, some of which involve passing regulations and empowering EMA.   “In the long term, EMA s...
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    Asia-Pacific Roundup: COVID-19 vaccine guidelines in India

    India’s Central Drugs Standard Control Organization (CDSCO) has published draft guidelines about the development of COVID-19 vaccines, falling in line other regulatory agencies by setting the bar for vaccine efficacy at a 50% reduction in infections, for example.   Several COVID-19 vaccines are in clinical development in India, including candidates from AstraZeneca, Bharat Biotech and Zydus Cadila (RELATED: COVID-19 vaccine tracker , Regulatory Focus 17 Sept. 2020)....
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    Euro Roundup: EMA publishes work plan for Big Data Steering Group

    The European Medicines Agency (EMA) has published the work plan for its Big Data Steering Group, listing the actions the group will take to fulfill its mission to advise EMA and the Heads of Medicines Agencies (HMA) about how to implement 10 priority recommendations.   EMA and HMA established the steering group in February. The group first met in May and has now shared an overview of the tasks that will occupy it through to early 2022.   The work plan is broken up ...
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    Asia-Pacific Roundup: Australia to permit some self-test IVDs after industry calls for change

    The Therapeutic Goods Administration (TGA) is set to allow the sale of a limited range of self-test in vitro diagnostics (IVDs) in Australia. TGA proposed the regulatory change after GlaxoSmithKline and other organizations used a consultation to voice their dissatisfaction with the current system.   Home-use tests for serious diseases have been banned in Australia for the past decade. TGA made an exception for HIV tests in 2014 but has otherwise maintained the position...
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    Euro Roundup: EU vows to hold COVID vaccine firms liable for side effects

    Developers of COVID-19 vaccines used in the European Union will be legally liable in the event of hidden defects or other problems with their products, a senior official at the Directorate-General for Health and Food Safety (DG SANTE) has vowed.   Last month, Reuters reported that differing opinions over the level of legal protection that should be afforded to developers of COVID-19 vaccines were hampering efforts to strike deals for the products needed to protect ...
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    Asia-Pacific Roundup: Face masks deregistered amid TGA postmarket review

    Almost 400 sponsors have pulled their face mask from the Australian Register of Therapeutic Goods (ARTG) amid a postmarket review undertaken by the Therapeutic Goods Administration (TGA) amid concerns that some recent listings triggered by COVID-19 fail to meet the legislative or performance requirements.   To date, 384 sponsors have voluntarily cancelled their ARTG listings. TGA noted that these devices have not been recalled as the agency has received no evidence in ...
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    Euro Roundup: Swissmedic resumes on-site inspections

    The Swiss Agency for Therapeutic Products (Swissmedic) has resumed regular on-site inspections amid an easing of COVID-19 restrictions in Switzerland.   The agency is taking precautions to mitigate the risks created by in-person interactions between its inspectors and the employees of the companies they visit. Inspections are only taking place if Swissmedic staff and targeted companies can adhere to measures related to distancing, hygiene and the tracing of coronavirus...
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    Asia-Pacific Roundup: TGA advises on Consumer Medicine Information summaries

    Templates for preparing summary pages for Consumer Medicine Information (CMI) documents cover six questions intended to help consumers understand how and why they are taking a medicine, according to new guidance from Australia’s Therapeutic Goods Administration (TGA).   The guidance anticipates new TGA requirements for CMI documents for newly registered prescription and some non-prescription medicines that go into effect in January 2021. Sponsors of medicines that come...
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    Euro Roundup: Denmark relaxes face mask label rules

    The Danish Medicines Agency (DKMA) is temporarily allowing companies to sell face masks that have English, Norwegian or Swedish instructions and labelling in an effort to boost the supply of CE-marked surgical face masks for consumer use.   Last weekend, Denmark mandated the use of face masks on public transport, significantly expanding the contexts in which Danes are expected to wear face masks. DKMA changed its position on the instructions and labelling of masks shor...
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    Asia-Pacific Roundup: Philippine FDA scales back as COVID cases spike

    An “alarming” rise in new cases of COVID-19 has led the Philippine Food and Drug Administration (FDA) to  ban face-to-face interactions with customers and set up drop boxes for depositing documents to help curb the spread of the virus in the country.   The rolling seven-day average of new COVID-19 cases in the Philippines passed 4,000 on 5 August, up dramatically from an average of less than 2,000 per day a week earlier. The surge led the Philippine government to reimp...
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    Euro Roundup: Swissmedic approval times slow down

    The Swiss Agency for Therapeutic Products (Swissmedic) took 4% longer to process each new application for a new active substance (NA NAS) through its standard procedure in 2019 than in 2018, according to a new benchmarking study.   The median processing time for NA NAS at Swissmedic last year was 555 calendar days. Over the same period, the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) reduced their median processing times, albeit only fract...
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    Asia-Pacific Roundup: Industry backs TGA software carve-out plan

    Australia’s Therapeutic Goods Administration (TGA) has received broad support for its proposal to exempt or exclude some software-based medical devices from regulations.   In a consultation, TGA asked which types of software-based products might be exempted from inclusion in the Australian Register of Therapeutic Goods or excluded from regulation by TGA on the grounds that they are regulated sufficiently by another body. Disease-management software, for example, might ...