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  • Feature ArticlesFeature Articles

    Update on trade issues affecting the dietary supplement industry

    This article discusses recent updates on US trade policy issues in the dietary supplement industry. It focuses on the trading relationship between the US and its largest trading partners, including China, and analyzes the ongoing effects of current trade policies on companies that produce, buy, and sell dietary supplements. The authors discuss tools available to US companies to reduce financial liability when trade policies are evolving at a rapid pace.   Introduction ...
  • Regulatory NewsRegulatory News

    ABPI Questions Lack of Details in Latest UK Update on No-Deal Brexit

    The UK’s Secretary of State for Health and Social Care Matt Hancock sent letters Friday on Brexit preparations for medicines supplies, offering details that the pharmaceutical industry group said need to be fleshed out further in the lead up to March 2019. In the event of a no deal scenario, the revised cross-Government planning assumptions show that there will be significantly reduced access across the short straits crossings into Dover and Folkestone for up to six mon...
  • Regulatory NewsRegulatory News

    Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

    The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can now rely on the inspections in each of those countries, reducing the need for duplicative work.   A total of 19 member states in the EU are now qualified by FDA as having the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. However,...
  • Regulatory NewsRegulatory News

    FTC Settles Complaint Over Deceptive Marketing of Unapproved Cancer Products

    The US Federal Trade Commission (FTC) on Thursday announced it has reached a settlement with CellMark Biopharma related to the company's claims about marketing efforts to sell two of its unapproved products. The settlement comes less than a year after FDA sent CellMark an advisory letter notifying the company that it must remove claims from its website and other materials indicating that CellAssure could treat or prevent cancer. FDA said that the company would need to ...
  • Regulatory NewsRegulatory News

    EMA and FDA to Begin Sharing Commercially Confidential Information

    Editor's note: this article has been updated with a statement from FDA clarifying that the agency must sign a confidentiality agreement with each EU country before unredacted inspection reports may be shared. As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will soon share non-public and commercially confidential information, including trade secret information. The a...
  • Regulatory NewsRegulatory News

    US Trade Report Highlights Pharma's IP, Counterfeit Issues Abroad

    The Office of the United States Trade Representative's (USTR) 2017 report on the state of intellectual property (IP) protection and enforcement in US trading partners around the world offers a look into concerns regarding market access barriers, particularly for those in the pharmaceutical and medical device industries. The report offers numerous examples of issues pharmaceutical and device companies deal with in some foreign countries, noting that these IP-intensi...
  • Regulatory NewsRegulatory News

    US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections

    After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic. Originally part of the Transatlantic Trade and Investment Partnership discussions under President Barack Obama , the agreement will allow US and EU regulat...
  • Regulatory NewsRegulatory News

    Updated: TTIP on Thin Ice Not Likely to Delay US-EU Mutual GMP Recognition Deal

    A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU will not be delayed, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions. Despite the TTIP pause, a spokesman from the EU ambassador told Focus  via email on Thursday evening ...
  • Regulatory NewsRegulatory News

    Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

    The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017. Under the new draft agreement, which is part of the fourth reauthorization of  the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the add...
  • USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries

    The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four countries. Trade Issues For the pharmaceutical and device industries, USTR highlights particular issues in Algeria, India, and Indonesia with regards to their “discriminatory, nontranspare...
  • USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries

    The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four countries. Trade Issues For the pharmaceutical and device industries, USTR highlights particular issues in Algeria, India, and Indonesia with regards to their “discriminatory, nontranspare...
  • Regulatory NewsRegulatory News

    TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

    After five years of negotiations, the release of the final text of the long-awaited trade deal, known as the Trans-Pacific Partnership (TPP), on Thursday, as well as concessions made to the US in the WTO’s TRIPS (trade-related aspects of intellectual property rights) deal announced Friday both offer new insight into the strength of the pharmaceutical industry’s lobbying and negotiating powers. TPP Early last month, a number of questions emerged over a sticking point ...