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  • Regulatory NewsRegulatory News

    Destination Cuba: Regulator Prepares for Influx of Novel US Pharmaceuticals

    With the restoration of diplomatic relations betweeen the US and Cuba in late 2014, the island is prepping for a wave of new and generic US pharmaceuticals and biologics, the head of the Havana-based regulatory agency, known as the Center for State Control of Drugs, Medical Devices (CECMED), told  Focus  in an exclusive interview. Rafael Pérez Cristiá, director general of CECMED, who oversees 300 staffers, said that as relations between the two countries continue to no...
  • Regulatory NewsRegulatory News

    FDA Finalizes New Regulations for Drugmakers a Decade After First Proposal

    After a decade of consideration, the US Food and Drug Administration (FDA) on Tuesday finalized new regulations governing drug establishment registration and drug listing for foreign and domestic firms, though the agency stopped short of finalizing several provisions that commenters took issue with. The new rule, expected to take effect in 90 days, includes amendments that reorganize, modify and clarify FDA regulations on who must register establishments and list human d...
  • Regulatory NewsRegulatory News

    FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

    The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies. The 142-page proposed rule outlines what’s referred to as a “GLP Quality System,” which will involve additional management responsibilities and standard operating procedures (SOPs), as well as a more nuanced approach for multi-site ...
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    European Commission Pushes for Closer Convergence With US on Device Regulations

    As part of the 14th round of ongoing negotiations of the Transatlantic Trade Investment Partnership (TTIP) between the US and EU, the European Commission has released a new proposal that would push for more collaboration on medical device regulations. The text of the proposal discusses some of the high-level themes of what both sides would to like find more common ground on, including the convergence of technical and clinical requirements applicable to devices; removing...
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    Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators

    The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue. Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, p...
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    EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations

    The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and  in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released. Following a legal-linguistic review of the two documents planned for September, the Council and Parliament could adopt the two draft regulations by the end of 2...
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    Asia Regulatory Roundup: China’s Anti-Corruption Agency Chides CFDA Over Loopholes (7 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China’s Anti-Corruption Agency Criticizes CFDA Over Regulatory Loopholes An inspection of China Food and Drug Administration (CFDA) by the country’s anti-corruption agency has led to the publication of a litany of alleged failings at the regulator. The graft group is calling for CFDA to standardize its review, approval and inspection processes to eliminate the “many loopho...
  • Regulatory NewsRegulatory News

    Updated: EU Reaches Agreement on New Medical Device, IVD Regulations

    The EU late Wednesday finally reached an agreement on updates to the overarching regulations for medical devices and in vitro diagnostics that haven’t been updated since the 1990s. The agreed to draft regulations, the texts of which were not released, are expected to ensure that medical devices and in vitro diagnostics are safe and that patients can benefit from them in a timely manner. The political agreement between the Netherlands presidency of the European Counc...
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    FDA Amends Regulations on General Biologic Standards for First Time Since 1977

    The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new manufacturing technology and testing capabilities. Issued directly as a final rule – because FDA says it believes the updates include “only noncontroversial amendments” and FDA anticipates no major objections from industry – the new regulations are part of FDA’s continuing effort to...
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    Asia Regulatory Roundup: CFDA Looks to Overhaul Supply Chain Controls Amid Vaccine Scandal (19 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Outlines Supply Chain Overhaul Following Vaccine Scandal The China Food and Drug Administration (CFDA) has outlined plans to overhaul regulation of the supply chain in the wake of a vaccine scandal currently engulfing the country. Officials are looking to implement a full vaccine traceability system, strengthen oversight of the cold chain and reform the centralized pr...
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    IMDRF Offers Progress Updates at March Meeting

    The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level. Background Originally launched as the Global Harmonization Task Force (GHTF) in 2012, the IMDRF is composed of regulators from Australia,...
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    Obama’s FY 2017 Budget Request: $5.1B for FDA, New Ways to Tackle High Drug Prices

    President Barack Obama unveiled his final budget request on Tuesday, and though Republicans have said it’s dead on arrival, the US Food and Drug Administration (FDA) would receive an 8 percent increase in funds to help further address drug compounders, device submissions and supply chain security. New ways to combat high prescription drug prices were also included in the request. The overall request from Obama and FDA includes a net increase of $14.6 million in budget au...