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    US regulations for regenerative medicine advanced therapies

    This article examines US regulations and guidance documents for regenerative medicine advanced therapies (RMATs). The author describes the field of regenerative medicine, noting that it is expanding at an accelerated pace, and outlines some of the common terms associated with it. He also addresses the application process for these therapies, accelerated regulatory pathways, market access, and the outlook for RMATs. The author cautions that, as exciting as these therapies a...
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    Regulation of advanced therapy medicinal products in the EU

    This article explains some of the terminology relating to advanced therapy medicinal products (ATMPs), including gene and cell-based therapies, tissue-engineered products, and combined ATMPs. The author explains the key EU regulations and guidance documents for each therapy type and discusses marketing authorization, accelerated regulatory pathways, and market access. He advises companies navigating this complex regulatory environment to engage with the regulatory agencies...
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    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...
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    Electronic platforms for submission of clinical trial information

    This article provides guidance for use of the European electronic platforms for retrieving and submitting information about clinical trials and compares them with other similar regional electronic databases, such as the US Food and Drug Administration’s MyStudies mobile app and Switzerland’s national platform, swissethics. The authors present an overview of some of the main international portals, available and under development, and provide an analysis of their specific as...
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    Impact of the Revised EU Clinical Trial Regulation

    Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulat...
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    CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions

    To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and ...
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    CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development

    This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China. 1 The first guidance published by the CFDA covers on-site inspections of generic drug development establi...
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    Draft CFDA Guidance on Drug Data Management Practices

    The China Food and Drug Administration (CFDA) has recently issued a new draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This article is a translation of the summary of the draft guidance. On 10 October 2016, CFDA issued draft guidance of drug data management practices for public comment. 1 Its purpose as detailed in Chapter I is the regulating the management of relevant data during th...
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    Registration Procedures for Medicinal Products in China

    This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...
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    Competency Expectations for the Regulatory Professional: A Changing Paradigm

    Regulatory professionals working for pharmaceutical service providers possess different competency levels, mainly depending on their previous experience. Recent market studies 1 reveal new trends in regulatory outsourcing and complete business processes are being transferred to service providers as strategic partners, necessitating changes in competencies expected from regulatory professionals. As a result of these changes, new competency paradigms will be based ...
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    Outsourcing: Not My Problem?

    The author attended a conference and workshop on outsourcing 2–3 December 2014 in Berlin. This article summarizes the topics discussed and the issues identified during the event, sponsored by the Parenteral Drug Association (PDA), which was well attended by industry representatives (contract givers), suppliers (contract acceptors) and consultants. It was clear from the discussions during and after the conference sessions the vast majority of outsourcing decisions an...
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    Pharmaceutical Outsourcing: A Korean Perspective

    The pharmaceutical industry in Asia has been growing rapidly for many years. However, while the pharmaceutical industries in China, Singapore and India are well known, much less is written about South Korea, perhaps because pharmaceutical products make up only 0.4% of its total exports. This article looks at the possible causes for this from a regulatory and compliance perspective, while taking into account the political agenda and other influencing factors. Speci...