RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    European Parliament Passes SPC Waiver in Landslide Vote

    The European Parliament on Wednesday voted through a proposal to allow manufacturing waivers to supplementary protection certificates (SPCs) by an overwhelming majority, with more than 75% of members voting in favor of the measure.   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse b...
  • Regulatory NewsRegulatory News

    EU Takes Another Step Towards Adopting SPC Waiver Proposal

    The European Union’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) is one step closer to adoption after EU ambassadors endorsed a compromise reached on 14 February with the European Parliament during a meeting of the Committee of the Permanent Representatives (Coreper) on Wednesday.   Now that the draft regulation has been agreed to, it will undergo a legal and linguistic review before being sent to the European Parliament and C...
  • Regulatory NewsRegulatory News

    EU Advances SPC Waiver Proposal

    The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) took a step forward on Wednesday after EU ambassadors backed the EU Council's position on the proposed regulation during a meeting of the Committee of the Permanent Representatives (Coreper).   "The draft regulation is expected to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established o...
  • Regulatory NewsRegulatory News

    Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal

    The European Parliament’s International Trade Committee (INTA) on Monday voted to adopt a draft opinion supporting changes to an amendment that would allow for manufacturing waivers to supplementary protection certificates (SPCs).   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse be...
  • Regulatory NewsRegulatory News

    European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs

    The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption. Background In the EU, SPCs, which apply to innovative pharmaceutical and plant protection products and have been increasingly used sinc...
  • Regulatory NewsRegulatory News

    US Trade Report Highlights Pharma's IP, Counterfeit Issues Abroad

    The Office of the United States Trade Representative's (USTR) 2017 report on the state of intellectual property (IP) protection and enforcement in US trading partners around the world offers a look into concerns regarding market access barriers, particularly for those in the pharmaceutical and medical device industries. The report offers numerous examples of issues pharmaceutical and device companies deal with in some foreign countries, noting that these IP-intensi...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA’s PRAC Seeks to Suspend Four Imaging Agents (16 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Asks to Suspend Authorizations of Four Imaging Agents After Reviewing Safety The Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents. PRAC put forward the proposal after finding “convincing evidence” accumulations of gadolinium are present in the brain many month...
  • Regulatory NewsRegulatory News

    Liquid-Proof Surgical Gowns? Now FDA Wants Companies to Prove It

    The US Food and Drug Administration (FDA) on Tuesday offered final guidance for companies that will have to conduct performance testing to support claims that their surgical gowns can keep out liquids and submit a 510(k) application within 60 days to the agency to prove those claims. Background In 2000, FDA issued a final rule clarifying the difference between gowns worn by health care personnel and surgical apparel worn by operating room personnel during procedures whe...
  • Regulatory NewsRegulatory News

    EU Personal Data Protection Reforms Move Forward

    After three years of deliberation, the European Council has agreed on its approach to data protection reform, allowing the council to initiate a trilogue with the European Parliament and Commission. Background The current rules governing data protection in the EU were adopted in 1995 under Directive 95/46/EC . However, there have been massive changes in how data is generated and used in the 20 years since the directive was adopted. In 1995, few Europeans had Internet...
  • Regulatory NewsRegulatory News

    Biologics Exclusivity Still Central in Trade Talk Debate

    The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history. While the US Trade Representative (USTR) and the biopharmaceutical industry have publicly called for a 12-year exclusivity period, Politico reports that some industry lobbyists are tempering their expectations. Background Among the 12 parties to TPP, the United States is the on...
  • 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 ...
  • Trade Associations Want Time Before Sunshine Act Begins

    • 29 August 2012
    The Centers for Medicare and Medicaid Services (CMS) is prepared to publish a final rule for the Physicians Payments Sunshine Act , but some trade associations are asking for more time before implementation of that rule. According to CMIO , four life science trade associations sent a letter to CMS, insisting sufficient notice be given before collection of data begins. They are asking for 180-day grace period after the final rule is released before reporting is required...