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  • Regulatory NewsRegulatory News

    Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

    Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies. The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compe...
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    Asia Regulatory Roundup: Japanese Regulators Receive Orphan Drug Training from EMA (6 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Japanese Regulators Receive Orphan Drug Training from EMA Staffers at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have received training on orphan medicines from the European Medicines Agency (EMA). The training session was led by Dr. Segundo Mariz, a member of EMA’s Committee for Orphan Medicinal Products (COMP). Mariz has worked on the committee since ...
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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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    Canada Proposes New Drug Enforcement Measures, Including Scheduling

    Canada's Minister of Health Rona Ambrose has just announced a series of amendments to the country's Controlled Drugs and Substances Act (CDSA) intended to curb illegal drug manufacturing and use. Proposed Changes The amendments are part of The Protection of Communities from the Evolving Dangerous Drug Trade Act , which increase the government's ability to police and regulate active substances, both legal and illegal. While the amendments are geared toward combating...
  • Feature ArticlesFeature Articles

    Six Recommendations Regarding Upcoming UDI Compliance Dates

    As 2014 fades into memory, the medical device industry faces the next phases of Unique Device Identification (UDI) implementation for devices marketed in the US. September 2015 is the deadline for UDI labeling implementation and data submissions for Implantable, Life-Supporting and Life-Sustaining (I/LS/LS) devices with the remainder of Class II devices following in 2016. 1 The Class III device UDI compliance date passed on 24 September 2014. Overall, implementation of ...
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    Massive Recall of Medical Devices Largest Ever Recorded by FDA

    A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA. Background: Recall Trends The devices, which were manufactured by Puerto Rico-based device manufacturer Customed, Inc, were given a Class I recall classification —FDA's most serious recall classification, given to those devices in cases where "there is a reasonable probability t...
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    Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following

    Finding information about the latest regulatory news can be profoundly difficult. Even with thousands of websites, hundreds of newsletters and dozens of subscription services, information that could affect you and your company can still slip through the cracks. Luckily, there's help, and lots of it—but only if you know where to look. Regulatory Intelligence on … Twitter? One of the most under-utilized sources of regulatory information is Twitter , a social media platf...
  • Brazilian Pharma Sector Submits Drug Waste Proposals

    After several extensions of the deadline by the Brazilian government, the Brazilian pharmaceutical sector has finally submitted three suggestions to the Ministry of Environment for a pharmaceutical sectoral agreement on the disposal of medicines by consumers  . After review by the Ministry, a final proposal will be submitted for consideration to the Steering Committee for the Implementation of Reverse Logistics Systems (CORI), which is coordinated by the Ministry ...
  • J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk

    Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...
  • Purdue's NDA for Oxycontin Formally Withdrawn as FDA Closes Route to Generic Competitors

    The US Food and Drug Administration (FDA) has announced the withdrawal of a new drug application (NDA) for Purdue Pharma's Oxycontin (NDA #20-553), the very same application that had lost patent protection in April 2013 and had been subject to potential generic competition before FDA said it would not approve any non-abuse-resistant formulations of the drug. Background Under current regulatory policy, approved drugs products are protected by several types of statutory p...
  • Feature ArticlesFeature Articles

    Legal Issues in Digital Pharmaceutical Communication in the EU--Part 3

    In March 2011, the European Commission launched a public consultation on an updated eHealth Action Plan for the period 2012-2020 1 , which had been called upon by the Council Conclusions on Safe and Efficient Healthcare through eHealth of December 2009 2 , and superseded the first plan adopted in 2004. Similarly, the US Food and Drug Administration (FDA) promotes the development of mobile medical apps that provide consumers and healthcare professionals with valuable he...
  • Survey of Americans Show Trust in Big Pharma Only Slightly Above Faith in Existence of 'Lizard People'

    • 05 April 2013
    Americans don't particularly trust the pharmaceutical industry. But the extent to which that trust deficit exists is on particularly glaring display in a new survey, which shows that more than one in seven Americans think the pharmaceutical industry is colluding to "invent" new diseases in order to profit off them, and 20% erroneously think vaccines cause autism. Survey Results The survey, conducted by the group Public Policy Polling, approached 1,247 registered voters,...