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  • FDA Extends Program in Hopes of Helping its Regulators Learn More About the Device Industry

    The US Food and Drug Administration (FDA) is once again extending a program intended to help its medical device review staff to better understand the regulatory process from the perspective of the industry it regulates. The ELP Program The program, known as the Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort for reforms at the Center for Devices and Radiological Health (CDRH) intended to accommodate criticism from industr...
  • Brazil Expedites Device Imports

    Brazil's national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing site is granted a Certificate of Good Manufacturing Practices (CBPF) by a foreign regulator.  Under the revised procedure (RDC 15/2014), new high tech devices should enter the Brazilian market sooner, since the analysis of the device by the agency can proceed while the ...
  • EMA Unveils New Adaptive Licensing Initiative, Meant to Provide Earlier Niche Approvals

    The European Medicines Agency (EMA) has announced that it will be launching what it's billing as an "adaptive licensing pilot project," an initiative intended to grant earlier access to medicines meant to treat unmet needs. Unlike the US' accelerated approval pathway, which grants a tentative but wide-ranging approval to a product based on interim data, EMA's adaptive licensing framework calls for the authorization of medicines for restricted (i.e. niche) patient populat...
  • New China FDA Document Clarifies Device Crackdown Plan

    On 15 March 2014, the China Food and Drug Administration (CFDA) issued a question and answer document designed to clarify the purpose of an earlier 13 March 2014 notice on the new national Special Action Program (SAP). That notice, sent to Chinese provinces and municipalities, called on local authorities to crack down on illegal activities relating to medical devices, and especially medical device registration, production, distribution and use.  The Program wi...
  • US, EU Regulators Extend QbD Pilot, Pledge Release of Further Quality Guidelines

    • 06 March 2014
    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have extended for another two years a pilot program that allows both agencies to simultaneously review quality-by-design (QbD) applications. Background The pilot program was first launched in March 2011 as a means by which both agencies could communicate review findings with respect to QbD elements of applications chosen for review. QbD refers to purposeful pharmaceutical development in which...
  • FDA to Continue Regulatory Training Program That Brings Together Regulators and Industry

    US pharmaceutical regulators have announced that they will continue a regulatory program that allows companies to invite officials from the Center for Drug Evaluation and Research (CDER) into their facilities to learn more about how the industry works. Background: Site Tours Program The program, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the Site Tours Program, has been in effect in various forms since 1999 when it was c...
  • FDA Program to Loosen Import Restrictions for 13 Major Pharmaceutical Manufacturers

    Thirteen of the US' most prominent pharmaceutical manufacturers will be allowed to import their products into the US with less regulatory scrutiny under a pilot program set to begin this year, the US Food and Drug Administration (FDA) has announced. Background FDA first announced the pilot program, known as the Secure Supply Chain Pilot Program (SSCPP) in January 2009 with that stated intent of better securing finished pharmaceutical products and their raw active ingred...
  • FDA Finalizes Massive Rewrite of Device Pre-Submission Guidance

    US Food and Drug Administration (FDA) officials on Tuesday released an extensive guidance document aimed at clarifying elements of the medical device pre-submission program, now used to provide manufacturers and application sponsors with feedback and advice. Those meetings are crucial to identifying, clarifying and mitigating any issues with a clinical trial or full medical device application, which can be delayed or derailed entirely by regulatory issues. The meetings, ...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program

    Regulatory Focus'  ongoing series of  Regulatory Explainers  wants to take complicated regulatory topics and make them simple for anyone to understand. In our latest Regulatory Explainer, we break down FDA's expanded access-sometimes referred to as compassionate use-regulations to understand how they work. Updated 4 February 2015. What's a Compassionate Use Program? Let's back up for a quick moment: Under current US Food and Drug Administration (FDA) regulations, ...
  • Program Intended to Clear Path for Easier Medical Device Studies Kept Alive

    The US Food and Drug Administration (FDA) has announced the extension of a pilot program first announced in November 2011 that aims to facilitate early feasibility studies for experimental medical devices. Background The 2011 announcement by FDA explained that the agency "intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the investigational device exemptions (IDE) requirements." IDE applications ar...
  • CDER to Continue Program Giving Regulatory Managers Insight into Pharmaceutical Industry

    US regulators announced this week their intent to continue a program they say allows companies to invite pharmaceutical regulatory officials into their facilities to go on site tours to learn more about the pharmaceutical industry and the way it produces its products. Background: Site Tours Program The plan, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the Site Tours Program, has been in effect in various forms since 1999,...
  • MHRA Advocates Use of Online Submissions Platform by Applicants

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is "strongly" encouraging all applicants to participate in its pilot participation in the Central European Submissions Platform (CESP), an online-based secure submissions system. Currently, applicants are permitted to submit applications to MHRA using data contained on CDs or DVDs, depending on the size of the submission. However, this submission style necessitates manual handing of media, storage spac...