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  • Regulatory NewsRegulatory News

    Companies Producing Drugs Only for INDs Exempt From FDA Registration

    The US Food and Drug Administration (FDA) on Monday published a correction to a recent final rule on registering foreign and domestic manufacturing establishments, clarifying that a company producing solely products for investigational new drug (IND) applications is exempt from registration. The more than 200-page final rule released in late August requires the electronic submission of the registration and listing information for all drug, active pharmaceutical ingredi...
  • 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's CDRH Adds New Online Tools to Help Industry Learn the Ropes

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released seven new modules of online information this week designed to help industry understand the various parts of medical device laws, regulations and policies. The multimedia catalog of online educational modules, known as CDRH Learn, has now grown to over 80 educational modules, which include presentations, printable slides and transcripts. FDA began releasing...
  • Regulatory NewsRegulatory News

    China to Raise Registration Fees, Still Far Lower Than US, EU, Japan

    The cost to register drugs and medical devices in China dramatically increased this week, and that could be a good thing for industry, Reuters reports. Background While the market for healthcare products has expanded exponentially in China in recent decades, the China Food and Drug Administration (CFDA) has struggled to keep up with incoming applications. In its 2014 Annual Report of Drug Evaluation , the Center for Drug Evaluation at CFDA said the number of back...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • Regulatory NewsRegulatory News

    British Regulators Launching Online Registration System for Low-Risk Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on 11 February 2015. The new  Devices Online Registration System (DORS)  will facilitate online registration of Class I devices, as well as cu...
  • Regulatory NewsRegulatory News

    Colgate, Other Generic Companies Hit by FDA for Failure to Pay Facility Fees

    The US Food and Drug Administration (FDA) this week issued an unprecedented four Warning Letters to companies, including the consumer healthcare company Colgate, for failing to pay user fees as part of the Generic Drug User Fee Act (GDUFA). Background The act, passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) , includes requirements that all generic drug facilities must register with FDA and pay an associated user fee meant t...
  • Regulatory NewsRegulatory News

    East African Community Registers Five Drugs in Pilot Program

    The East African Community Medicines Regulatory Harmonization (EAC-MRH) program reached a major milestone this year with the successful registration of five critical health products. The medicines—three antimalarial and two reproductive health products—were reviewed in a joint effort by all five EAC member states: Burundi, Kenya, Rwanda, Tanzania and Uganda. This effort, a pilot project launched in July 2013 with support from the World Health Organization (WHO), marked th...
  • Spain Launches new Registry of API Manufacturers, Distributors, Importers

    The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, import and distribution of pharmaceutical active ingredients in Spain. The Unified Public Business Registry of Active Substance Businesses (RUESA) is part of the transposition of Directive 2011/62/EU , which addresses counterfeit drugs in the European Union and includes additional controls for active ingredients. The aim of the RUESA is to s...
  • Regulatory NewsRegulatory News

    Brazil's Anvisa Pushes Expedited Approvals for Generics, Biologics

    Brazilian regulator Anvisa has launched a simplified procedure (RDC No. 31) for the registration, post-registration and renewal of registration of generic, similar, herbal, biologic, “dynamized” and “specific” drugs.  So-called "dynamized" drugs in Brazil are preparations from substances that are subjected to successive dilutions, that are administered as homeopathic, anthroposophic or homotoxicological therapy.  Specific drugs are products that do not fit int...
  • Regulatory NewsRegulatory News

    Sterility Concerns Lead to Warning Letter, Import Alert for German Pharmaceutical Manufacturer

    The US Food and Drug Administration (FDA) has sent a Warning Letter to German-based pharmaceutical manufacturer SANUM-Kehlbeck GMbH & Co alleging that it violated current good manufacturing practices (CGMP) at its Hoya, Germany facility. The company also failed to register its facility with US regulators in violation of Section 510 of the Federal Food, Drug and Cosmetic Act (FD&C Act) , FDA charged in its 11 April 2014 letter to the company , released today. The bulk...
  • Time for Generic Pharma Companies to Re-Identify Themselves, FDA Says

    The US Food and Drug Administration (FDA) is reminding all manufacturers of generic drug products, including active pharmaceutical ingredients used in generic drug manufacturing, that they need to re-register with the agency under the terms of a 2012 law. Background In the lead-up to the 2012 passage of  The Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA regulators highlighted a growing problem: Many generic drug manufacturers were moving the...