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  • Regulatory NewsRegulatory News

    Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

    • 10 July 2014
    Four US senators are pressuring the US Food and Drug Administration (FDA) to walk back a rule proposed by the agency in May 2014 that would make it more difficult to import unapproved drugs into the US. Background The proposed rule, Administrative Destruction of Certain Drugs Refused Admission to the United States , is meant to tweak the agency's pharmaceutical import provisions under Section 801(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under the ...
  • Regulatory NewsRegulatory News

    FDA Releases 33 New Medical Device Standards

    US medical device regulators have announced more than 30 new additions to their list of recognized device consensus standards. In a Federal Register announcement on 9 July 2014, the US Food and Drug Administration (FDA) announced its 36th update to its "List of Recognized Standards"—its fourth update to the list in 2014—containing dozens of modifications and 33 newly recognized standards. Those standards come to be recognized by FDA through a process known as "i...
  • Regulatory NewsRegulatory News

    FDA Launches New 'Trusted Trader' Import Program With Long List of Incentives

    The US Customs and Border Protection (CBP) and US Food and Drug Administration (FDA) have announced the launch of a new "Trusted Trader" program meant to expedite the import of products made by companies that meet a rigorous selection process. Background FDA and CBP have long sought to make improvements to the process used to import of products, and particularly pharmaceuticals. As explained in numerous Federal Register announcements over the years, the problem ...
  • Regulatory NewsRegulatory News

    Final Regulation Makes it Easier for FDA to Seize Drugs at the Border

    The US Food and Drug Administration (FDA) is finalizing without change a proposed regulation introduced last year which would establish an administrative detention process for pharmaceutical products it believes are adulterated or misbranded. Background The rule is borne from the  Food and Drug Administration Safety and Innovation Act (FDASIA) , Section 709 ("Administrative Detention") of which ordered FDA to promulgate a final regulation within two years of the passage...
  • FDA Moves to Close Glaring Loophole in Current Drug Import System

    A proposed rule issued by the US Food and Drug Administration (FDA) would make it easier for the agency to destroy low-value drugs refused admission into the US under federal law. Background: Import Regulation The backbone of pharmaceutical regulation in the US is the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Section 801(b) of the FD&C Act , FDA is permitted to refuse to allow the import or entry of any drug that has not been approved (under Sect...
  • Feature ArticlesFeature Articles

    Debarred, Denied, Restricted? Legal Responsibilities in Outsourcing

    • 29 April 2014
    Regulatory professionals frequently work with their supply chain colleagues to ensure all relevant documentation is provided for the export of goods from the country of origin. However, there are little-known US regulatory requirements with potentially significant administrative and criminal consequences for violation, and many manufacturers may not be aware of them. The US Departments of Commerce, State and the Treasury publish lists of US and international individuals a...
  • 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 ...
  • Reasons for Shortage Unclear, House Members Ask FDA to Consider Importing Alternatives

    The US Food and Drug Administration (FDA) may have recently unveiled a new rule intended to facilitate more coherent responses to ongoing drug shortages, but some legislators are now hunting for answers about one shortage of a drug used to treat childhood cancer patients, saying neither the agency nor the drug's manufacturer have been able to provide answers thus far. Background As regular readers of Focus well know, drug shortages have been an endemic problem in the ...
  • Shortages Ongoing and Import Approach in Legal Jeopardy, FDA Turns to Expedited Approvals

    Despite the US Food and Drug Administration's (FDA) ongoing efforts, the problem of drug shortages is persisting with a stubborn tenacity, particularly in several high-need areas. But with its existing method of alleviating drug shortages in legal jeopardy, FDA now seems to be adopting a more permanent tactic to confronting some shortages: full and expedited approvals. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injecta...
  • India Establishes Procedures for Importing Pharmaceuticals for Personal Use

    India's Central Drugs Standard Control Organization (CDSCO) has established procedures for the import of small quantity of drugs for personal use "for the needy patients of India." Generally, an individual can import a quantity not to exceed 100 "average doses" as long as the drug is part of the "bona fide" personal luggage of the individual and is declared to Customs.  However in "exceptional cases," an individual may import "a large quantity" for personal use ...
  • Feature ArticlesFeature Articles

    Document Authentication for Product Registration/Regulatory Submissions Outside the US

    • 01 August 2013
    Have you ever opened your email to find a message that contained something like: "This CFG/CFS/CPP/COE 1,2,3,4 must be apostilled 5 for Russia"? "These ISO certs 6 need legalization (or consularization) from the Consulate of Brazil"? Either you are very familiar with these requirements or, particularly if your company is relatively new to foreign markets, you have no idea what these terms mean. It's important to know that when engaged in marketing its medical...
  • UPDATED: CDER Agenda Foreshadows Release of Guidances Long Sought by Industry

    The Center for Drug Evaluation and Research (CDER), the US Food and Drug Administration's (FDA) primary drug regulatory body for chemical and biological drugs, has released a comprehensive list of all guidance documents it plans to release during the 2013 calendar year, including many long-awaited by the pharmaceutical and biopharmaceutical industries. Update (8 March 2013) : FDA regulators have added three new guidance documents set to be released by CDER in the ...