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  • Regulatory NewsRegulatory News

    FDA Compiles List of NDAs Transitioning to BLAs Next March

    The US Food and Drug Administration (FDA) on Tuesday released a preliminary list of the new drug applications (NDAs) that will be converted to biologics license applications (BLAs) on 23 March 2020. The shift is caused by the Biologics Price Competition and Innovation Act of 2009 , which clarified the statutory authority under which certain protein products will be regulated by amending the definition of a “biological product” to include a “protein (except any chemical...
  • Regulatory NewsRegulatory News

    BIO Targets Compulsory Licensing, Regulatory Reforms Across Various Countries

    Following the release of PhRMA’s Special 301 Report urging the Office of the US Trade Representative to better protect American pharma companies’ intellectual property in foreign countries, BIO has released its own report this week, with an eye toward compulsory licensing and regulatory data protection. Similar to PhRMA, BIO singles out Malaysia as a “Priority Foreign Country” following the issuance of a compulsory license in 2017 to make generic versions of Gilead’s he...
  • Regulatory NewsRegulatory News

    FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

    The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product. The efforts are part of FDA’s decade-long work to begin, starting in March 2020, transitioning the approved...
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    Malaysia Issues Compulsory License for Gilead Hepatitis C Drug

    Late last month, Malaysia's government issued a compulsory license in an effort to offer a less-expensive version of Gilead's hepatitis C drug and increase access. Reports of the government move in Malaysia coincided with Gilead's decision on 24 August to extend its voluntary licenses on its hepatitis C medicines to include Malaysia, Ukraine and Belarus. Previously, the company signed agreements with 11 India-based manufacturers to make generics of its hepati...
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    Fast Start for FDA Drug Approvals in 2017

    The US Food and Drug Administration (FDA) is poised to make a comeback from the relatively low number of new drugs approved in 2016, though it's unlikely to match the approval highs from 2014 and 2015. Already in 2017, FDA has approved 14 new drugs , though that quick pace is not likely to continue and the rest of the year is shaping up to be an average or slightly above average year for approvals. Based on data from BioPharmCatalyst , FDA has just over 20 remaining a...
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    Indian Manufacturer Seeks Compulsory License for Type II Diabetes Drug Saxagliptin

    An Indian manufacturer has filed the third-ever compulsory license application in India for AstraZeneca's type II diabetes drug saxagliptin, SpicyIP reports. Background Compulsory licensing is a legal provision that allows for the licensing of intellectual property rights without the rights holder's consent. The power to grant these licenses is seen by some countries, especially low- and middle-income ones, as a powerful tool to ensure important drugs are available a...
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    European Commission Says Compulsory Licensing can Only Happen at National Level

    After being questioned by a member of the European Parliament, the European Commission (EC) says neither it nor the European Medicines Agency (EMA) have the power to acquire patents or issue a compulsory license. Background In the past two years, drugmakers have launched several drugs to treat hepatitis C (HCV), a disease which left untreated can lead to cirrhosis or liver cancer. The new generation of HCV treatments, led by Gilead's Sovaldi and Harvoni, are highly eff...
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    WTO Reviews India's Trade Policies, Including Drug Patents, Compulsory Licensing

    The World Trade Organization (WTO) is conducting its sixth review of India's trade policies this week. To coincide with the review, the WTO Secretariat has released a report on India's trade and related policies, which highlights areas of many areas of progress, while noting some areas of concern related to India's policies on drug patents. Background The WTO routinely reviews its members' trade-related policies in order to track developments that may affect global ...
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    Trade Group Wants to See Stricter Limits on Compulsory Licensing

    A US-based trade group wants to see the United States Trade Representative (USTR) pursue stricter limits on the ability of countries to bypass patent protection. In its Special 301 Submission 2015 , the Pharmaceutical Research and Manufacturers of America (PhRMA) argues that compulsory licenses should only be issued in “exceptional situations,” where there is a pressing public health need. What is a Compulsory License? Compulsory licensing (CL) is a legal provisi...
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    New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada, Canada’s medical device market regulator, has published new  guidance  requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications. Set to take effect 1 December 2014, the new rules will require Class III and IV MDL applicants to submit premarket review documentation...
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    Latest Information on Health Canada Review and Approval Times for MDEL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada regularly publishes performance data with respect to Medical Device License applications (Class 2-4); however, the data publically available for Medical Device Establishment License (MDEL) applications has generally been limited.  To gain a better understanding of MDEL applications, Emergo's Vancouver office contacted H...
  • India Moves to Grant Three More Compulsory Licenses for Cancer Medications Based on Cost

    • 03 May 2013
    India's Union Health Ministry is pursuing three more compulsory licenses that would allow generic manufacturers in the country to compete with patent-protected medicines, including Roche's Herceptin and Bristol-Myers Squibb's Sprycel and Ixabepilone, reports PharmaBiz .  The announcement comes just months after the country's Supreme Court issued a landmark compulsory license for Bayer's Nexavar (sorafenib). What made that decision so remarkable to both critics...