• 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...
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    FDA Kicks Off MDUFA Reauthorization Process

    The US Food and Drug Administration (FDA) is kicking off the reauthorization process for the Medical Device User Fee Act (MDUFA), a program which funds a significant portion of its medical device regulatory review activities. Background FDA's user fee program began with the passage of the Prescription Drug User Fee Act (PDUFA) in 1992. The law, originally intended to speed up the regulatory review process, wound up being so popular that it inspired several other user ...
  • Regulatory NewsRegulatory News

    FDA Kicks off Generic Drug User Fee Reauthorization Process

    Regulators and generic pharmaceutical companies, start your engines. The race to the next reauthorization of the Generic Drug User Fee Act (GDUFA) has begun. In a Federal Register notice on 21 April 2015, the US Food and Drug Administration (FDA) announced that it will begin accepting comments regarding the first-ever reauthorization of GDUFA—a user fee arrangement which funds much of FDA's generic pharmaceutical regulatory activities. Background GDUFA was first pa...
  • 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

    Guess Which International Medical Device Facilities are Most Likely to be Inspected?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Let’s say you have responsibility for international facilities in Germany, China a...
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    FDA System to Keep Track of Drug Manufacturers Nears Completion

    A new guidance published by the US Food and Drug Administration (FDA) establishes a specification by which all drug establishments will be identified under a recently established tracking system. Background Under the  Food and Drug Administration Safety and Innovation Act ( FDASIA )  of 2012, both domestic and foreign facilities whose products are imported into the US are now required to register with FDA. Specifically:  ''During the period beginning on October 1 a...
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    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...
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    Tropical Disease Priority Review Voucher Fee Set to Rise

    The US Food and Drug Administration (FDA) is set to increase the fee it charges users of a special, transferable voucher meant to reward developers of tropical disease treatments with an expedited review process for any subsequent drug product. Background The voucher, known as a tropical disease priority review voucher, was established under the FDA Amendment Act of 2007 (FDAAA) . Under the law, companies that receive approval for a tropical disease treatment are eligi...
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    FDA Announces all User Fees to be Paid by Pharma, Device Industries in 2015

    The US Food and Drug Administration (FDA) has now released all user fee amounts for the coming 2015 Fiscal Year, including fees for medical devices, pharmaceuticals, generic drugs, biosimilar drugs, drugs compounded at outsourcing facilities, animal drugs and generic animal drugs. The current FY 2014 user fees are also displayed, as are fees from FY 2013, when most programs were overhauled under the Food and Drug Administration Safety and Innovation Act (FDASIA) . Thi...
  • Regulatory NewsRegulatory News

    Medical Device User Fees Set to Drop in 2015, But Not by Much

    The US Food and Drug Administration (FDA) has announced the fees it plans to charge manufacturers of medical device products in Fiscal Year (FY) 2015 under the Medical Device User Fee (MDUFA) program. The fees, which were updated in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) , are collected by FDA and used to hire additional review staff and make other improvements at the agency meant to speed up device review times. Under FDASIA , ...
  • 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...