RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • RoundupsRoundups

    Euro Roundup: EMA plans new bodies to manage tasks created by extended mandate

    New authority created by EU legislation means the European Medicines Agency (EMA) is poised to create several new bodies and formalize existing groups to manage crisis preparedness regarding medicinal products and medical devices.   Through the legislation, EU authorities have made permanent some structures and processes EMA put in place to manage the COVID-19 pandemic and given the agency responsibility for certain new tasks.   EMA now must establish an Executive ...
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    Asia-Pacific Roundup: TGA seeks feedback on priority pathway for cell therapies

    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into the feasibility, potential eligibility criteria and determination process for a proposed priority review pathway for biologicals such as cell therapies.   Trade group Medicines Australia used a recent parliamentary inquiry to push for biologicals – goods that contain or are derived from human cells or tissues – to become eligible for priority review and provisional registration. AusBiot...
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    Euro Roundup: EFPIA pushes back against price transparency in EU cancer strategy

    A proposal to publish the net prices of cancer drugs in different EU countries will remove “the flexibility for companies to adapt the price of a medicine to a Member State’s economic and healthcare settings,” according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).   As part of a wide-reaching text on equal access to cancer treatments, the European Parliament has called for “more transparency throughout the pharmaceutical system, esp...
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    Asia-Pacific Roundup: New Zealand seeks feedback on harm warning on opioid labels

    The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on its plans to add a warning about risks of overdose and dependence to the labels of opioid medicines.   New Zealand already requires an addiction warning on codeine-containing medicines. Now, the Medicines Adverse Reactions Committee is recommending  a similar warning and advisory statement for all opioid medicines. The committee noted that warnings included in the Label Stat...
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    EU posts guidance on verifying high-risk IVDs, oversight of legacy devices

    Two new guidance documents from the European Commission’s Medical Device Coordination Group (MDCG) aim to provide more information on applying new medtech regulations.   First up is the guidance to notified bodies on verifying in vitro diagnostic (IVD) devices in class D, the highest risk category. The incoming In Vitro Diagnostic Regulation (IVDR) reserves class D for tests that could pose a high risk to both patients and public health, such as products that check for...
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    Euro Roundup: EMA starts review of JAK inhibitor safety after seeing heart signal

    The European Medicines Agency (EMA) has begun a review of the safety of Janus kinase (JAK) inhibitors after a clinical trial showed patients at risk of heart disease who took Pfizer’s Xeljanz (tofacitinib) were more likely to have a major cardiovascular problem and had a higher risk of developing cancer.   Xeljanz use was linked to a higher rate of heart attack, stroke or death due to cardiovascular disease, higher risk of cancer, and higher risk of death due to any ca...
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    Asia-Pacific Roundup: India relaxes rules on COVID treatments

    The Indian government is deferring some routine requirements for developing and manufacturing to help get COVID-19 therapeutics to market.   “Provided that the requirement of prior permission from the Central Licensing Authority under rule 81 of the New Drugs and Clinical Trials Rules, 2019 to manufacture the new drug as required under rule 83 of the said rules shall be deferred in public interest to meet the emergent situation arisen out of COVID-19,” the notification...
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    Euro Roundup: EMA warns sack of COVID temp staff will hurt

    The European Medicines Agency (EMA) has warned the termination of 40 temporary pandemic staff will “significantly impact” its ability to perform post-authorization activities and other ongoing responsibilities related to COVID-19.   Recognizing the strain that the pandemic was placing on EMA, European Union officials authorized 40 temporary staff in 2021 and 2022. COVID-19- related work currently occupies 70-80 full-time equivalents at the agency.   In a planning d...
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    Asia-Pacific Roundup: Years after EMA action, Malaysia rejects BE studies over GCP issues

    Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has rejected bioequivalence studies done at two facilities run by Micro Therapeutic Research Labs in India. The action comes five years after the European Medicines Agency (EMA) warned pharmaceutical companies it would not accept results from studies performed at the two facilities in marketing authorization applications.   EMA issued its notice in March 2017. The notice followed a February 2016 inspection t...
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    Euro Roundup: MHRA posts guidance on clinical trial risk assessments, oversight

    The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on clinical trial risk assessments, oversight and monitoring in two new documents.   MHRA is asking sponsors to perform and document a risk assessment for each proposed clinical trial as early as possible to determine whether it falls under the Clinical Trials legislation, how the agency will categorize the trial and whether there are barriers to its execution.   “The risk assess...
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    Asia-Pacific Roundup: TGA proposal warns of continuing cost pressures

    Australia’s Therapeutic Goods Administration (TGA) proposes to increase industry fees for 2022-2023 by 2.6%, based on it’s long-established index factor, despite continuing cost pressures caused by limited revenue growth and increases in costs not recovered by those fees.   The increase is forecast to generate an additional AU$ 4.6 million ($3.3 million) for TGA – but falls short of the 3.3% rise TGA calculates would be needed to cover its costs. TGA almost always uses...
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    Euro Roundup: Swissmedic shortens time limits for reporting foreign safety signals

    The Swiss Agency for Therapeutic Products (Swissmedic) has cut the time limits for reporting signals that are classified as emerging safety issues. Under the new rules, marketing authorization holders have five days to report a signal and 15 days to bring the process to its conclusion.   Swissmedic is applying the new limit to emerging issues such as urgent procedures and safety-related referral procedures in the EU. The agency expects companies to report signals immed...