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  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    This article discusses drug shortages in Germany, the root causes of production problems with active pharmaceutical ingredients, and drug product manufacturers. The authors offer analysis from the perspective of a medium-sized generic drug manufacturer. They outline a range of reasons for the shortages, all of which point to a “broken marketplace.” The authors conclude with a discussion of mitigation activities and address the current COVID-19 pandemic. They warn that drug...
  • Regulatory NewsRegulatory News

    FDA Issues Delayed DSCSA Grandfathering Guidance

    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA). While the guidance comes two years after the deadline set by the DSCSA and on the same day that requirements for manufacturers to begin affixing or imprinting product identifiers on packages and homogenous cases ...
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    FDA Offers Draft Guidance to Further Secure Drug Supply Chain

    The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013. Background The DSCSA outlines the path to better secure the US drug supply chain via an electronic, interoperable system by 2023 to track and trace certain prescription drugs as they are distributed. The law helps FDA ensur...
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    FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings

    The US Food and Drug Administration (FDA) on Wednesday announced it plans to launch a pilot program aimed at exploring issues related to the interoperable electronic system for drug tracing required under the Drug Supply Chain Security Act (DSCSA) by 2023. The agency also announced that it will hold a series of public meetings on DSCSA-related issues in August 2017, December 2017 and February 2018. At the meetings, FDA says it plans to discuss issues ranging fr...
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    FDA Official Highlights Foreign Supply Chain Challenges

    Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research. Speaking at the Food and Drug Law Institute's annual conference on Friday, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers, which fi...
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    Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration

    With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion. The new toolkit, born out of a five-year collaborative project that actually took four years to complete, brings expertise from the US Pharmacopeial Convention (USP), US Food and Drug Admin...
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    Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes Electronic Platform to Monitor Drug Supply Chain The Indian government is proposing to create an electronic platform to monitor the drug supply chain. Officials want all manufacturers, distributors and pharmacies to register on the platform and upload details of batches they supply and receive in an attempt to raise drug standards in India. India’s Mini...
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    FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section

    The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate. Under the new section, which FDA says is being distributed “for comment purposes only,” the agency offers its interpretation of Section 582(b)(4)(B)(ii)(II) of the Food, Drugs and ...
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    Asia Regulatory Roundup: CFDA Proposes Sourcing Requirements for Drug, Device Companies (3 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Proposes Sourcing Requirements for Drug, Device Firms as Traceability Agenda Gathers Pace The China Food and Drug Administration (CFDA) has released another piece of its proposed strategy for implementing a traceability system across the country. In the latest text, the regulator has set out plans to make drug manufacturers assess the quality of their raw material sup...
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    HHS Inspector General to Look Into Six FDA Programs in FY2016

    Over the next year, HHS’ Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration’s (FDA) requirements for post-marketing studies for new drugs, the exchange of information between drug supply chain partners and FDA’s oversight of networked medical devices in hospitals, as well as three other programs linked to the regulation of food and tobacco. Although the majority of OIG’s work is tied to the oversight of Medicare and Medicaid fu...
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    China Adopts Milestone Device Good Supply Practices

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices. The GSP regulatio...
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    With Weeks Until Drug Track and Trace System Launches, FDA Issues New Guidance

    With just weeks left until new tracking standards come into effect, the US Food and Drug Administration (FDA) is releasing new recommendations it hopes will better secure the pharmaceutical supply chain from accidents and counterfeiters alike. Background In 2013, Congress passed and President Barack Obama signed into law the  Drug Quality and Security Act  ( DQSA ). While the law is perhaps better known for its extensive pharmaceutical compounding reform provisions, it ...