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  • Regulatory NewsRegulatory News

    FDA Touts Quality Office’s Achievements in 2018

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Thursday released its 2018 annual report touting its accomplishments in a year that saw record numbers of new and generic drug approvals.   OPQ is the office responsible for quality assessments for investigational new drug applications (INDs) and all marketing applications reviewed by the Center for Drug Evaluation and Research (CDER), including new drug applications (NDAs), abbreviat...
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    IFPMA Seeks Global ban on Gifts and Promotional Aids for Medicines

    As part of a push to align the rest of the world with the US and EU, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) is seeking to establish a global ban on gifts and promotional aids for prescription medicines, wherever its member companies operate. “Any exceptions based on the custom of gifts to mark significant national, cultural or religious events (for example, mooncakes or condolence payments) have also been removed,” the group ...
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    Industry Groups Explain Competition Issues in the US Pharma Market

    Industry groups representing generic and brand-name drugs, pharmacy benefit managers (PBMs) and pharmacies offered their comments on a November meeting held at the Federal Trade Commission (FTC) on possible solutions to increase competition and lower pharmaceutical prices in the US. The organizations discussed differing views on what can be done, with the generic group noting its own declining prices and possible ways to combat abuses, the brand-name industry point...
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    European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs

    The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption. Background In the EU, SPCs, which apply to innovative pharmaceutical and plant protection products and have been increasingly used sinc...
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    Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System

    The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay. Although none of the comments and arguments for reducing the price of pharmaceuticals were new, panelists and senators even seemed to disagree on what exactly is causing prices in the US to be so much higher than the rest of the world. Mark Merritt, president of the Phar...
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    Health Canada Seeks to Update User Fees for Drug and Device Firms

    Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data. In addition to increasing some fees significantly (see more below on some of the changes), the proposal would also give new authority to Health Canada to withdraw or withhold service or approval if a fee is not paid, and all fees moving fo...
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    340B: Health System Execs Push Back on Narrowing of Drug Discount Program

    The House Energy & Commerce's subcommittee on Oversight and Investigations on Wednesday discussed the federal 340B drug discount program, which provides participating hospitals and other medical providers deep discounts on outpatient drugs.  Background In 1992, Congress created the 340B program to mandate that pharmaceutical manufacturers provide discounts for certain drugs, which can range between 25% and 50% for average wholesale prices. The Health Services and ...
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    IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018

    The International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) have agreed to consolidate their work into a joint initiative that is expected to be operational in January 2018. According to a summary of the 5th meeting of the IGDRP in Ottawa in June, the IPRF management committee and the IGDRP steering committee expressed support for the consolidation of the IPRF and IGDRP initiatives in order to best respond to ...
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    EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form

    The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA). The update, drafted in July 2015 , comes as there has been an increasing trend toward the outsourcing of manufacturing and more complex supply chains. The guideline "does not introduce new requirements" on authorized drugs, though t...
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    Senate Committee Takes First Step on Rising Pharmaceutical Prices

    The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down. Sen. Lamar Alexander (R-TN) opened the hearing by highlighting the extent to which biopharmaceutical companies pay for the development of new medicines, and to note there will be two more hearings focused on R&D and supply chain expenses, ...
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    EMA Plots New Ways to Help Small and Medium-Sized Pharma Firms

    The European Medicines Agency (EMA) on Wednesday published an action plan for the next three years to help small and medium-sized pharmaceutical companies. The plan seeks to support such companies through all stages of drug development and to further engage with sectors adjacent to pharmaceuticals (e.g. companion diagnostic technologies, medical technologies industries and digital health) in light of Europe’s new medical device legislation , advances in pharmaco...
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    FDA to Drug Manufacturers: Beware Water-Borne Contaminants

    With a crop of recent product recalls due to Burkholderia cepacia complex (BCC) contamination, the US Food and Drug Administration (FDA) on Monday warned drug manufacturers of non-sterile, water-based drug products of the dangers that BCC and other water-borne opportunistic pathogens pose. “BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents,” FDA said in a stat...