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  • Regulatory NewsRegulatory News

    FDA Warns Chinese Drug Testing Facility for Refusing Inspection

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in August to China-based drug testing facility Shanghai Institute of Pharmaceutical Industry for refusing an inspection. FDA had planned a surveillance and pre-approval inspection of the facility from 29 November to 4 December 2018, but the company told FDA’s China office in a written response that it was refusing the inspection. "Under section 501(j) of the Federal Food, Drug, and Co...
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    EMA Offers Q&A on Exemptions From Batch Re-Testing for Imported ATMPs

    The question and answer (Q&A) document released by the European Medicines Agency (EMA) on Wednesday describes when an exemption from EU batch re-testing can be granted for imported advanced therapy medicinal products (ATMPs). The three-page Q&A begins by noting that a Qualified Person (QP) has to ensure each batch of imported ATMP is re-tested upon importation. But the QP can certify that the imported batch relies on controls conducted in a third country if the product ...
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    Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

    The European Medicines Agency (EMA) and European Directorate for the Quality of Medicines and Healthcare (EDQM) on Thursday released a report detailing findings from EMA’s drug sampling and testing program over the last 20 years.   EMA says it plans to extend the program to include biosimilars and that it will expand the generic sampling and testing program first launched in 2011 to include products authorized via the mutual recognition and decentralized procedures. ...
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    Vanda Pharmaceuticals Sues FDA Over Partial Clinical Hold

    In a complaint filed against the US Food and Drug Administration (FDA), Vanda Pharmaceuticals called on a federal district court to lift a partial clinical hold on its experimental drug tradipitant. The complaint—filed with US District Court for the District of Columbia on Tuesday—alleged that FDA acted in violation of the Administrative Procedure Act of 1946 (APA) in imposing the partial clinical hold last December. The hold was imposed on a protocol for a new clinic...
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    Dissolution Testing: British Pharmacopoeia Responds to Consultation

    The British Pharmacopoeia on Monday released its response to its consultation on dissolution testing and announced its plans to update its approach within its product monographs.   The British Pharmacopoeia first launched the consultation in January 2017 to gather input from stakeholders on ways the pharmacopoeia could improve its approach to dissolution testing in its finished product monographs.   Dissolution testing is performed for solid oral drugs to determi...
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    EMA Updates on 3Rs Guideline Review

    The European Medicines Agency (EMA) on Tuesday published a report on actions taken to update its guidelines following a review of 3Rs, or replacement, reduction and refinement, principles to reduce the need for animal testing of medicinal products.   In 2014, EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) launched a review to update their guidelines to ensure they align with 3Rs best practices....
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    FDA Announces Streamlined Review Pathway for DTC Genetic Tests

    The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market. To do so, FDA is proposing a model similar to a pilot for digital health products, by which companies can be pre-certified to market low-risk software-based devices following an assessment of their systems for software design, validation and maintenance. Similarly, F...
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    FDA: Lead Test Company May Have Violated Federal Law

    The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems. FDA cited the issues in a 10-page inspection report stemming from a month-and-a-half long inspection of Magellan's North Billerica, MA facility from 10 May to 29 June 2017. A week into that inspection, FDA warned the public that all four of Magel...
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    European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (30 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Starts Consultation on Quality of Inhaled Pharmaceutical Products The European Medicines Agency (EMA) has started a consultation on planned changes to its stance on the pharmaceutical quality of inhaled and nasal products. EMA published the concept paper to start bringing its guidance in line with changes in thinking about therapeutic equivalence since it released its cu...
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    EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research

    The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating that, when alternatives do not exist, the appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for pharmaceutical safety assessments. The opinion is part of a process to reevaluate the same conclusion from 2009 that “recognised that animals s...
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    FDA Revises Guidance on Safety Testing of Drug Metabolites

    The US Food and Drug Administration (FDA) on Tuesday released revised guidance on recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The revisions mean the new guidance supersedes guidance from February 2008. The guidance has been revised to be in alignment with ICH guidance, known as M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authori...
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    Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue

    Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway. Background The Animal Rule pathway (codified here ) was designed to allow companies to bri...