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

 
  • Regulatory NewsRegulatory News

    Australia Unveils Device Action Plan

    Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on and the agency and device regulatory system. The plan also identifies additional opportunities for TGA to increase transparency, with stakeholder consultations on proposed changes to regulatory requirements and forthcoming guidance materials. Until early 2020, potential c...
  • Regulatory NewsRegulatory News

    Updated: House Passes GOP Tax Overhaul With Orphan Drug Tax Credit Repeal Included

    The US House of Representatives on Thursday passed a bill to reform the US tax code by a vote of 227 to 205, with all Democrats voting against it and all but 13 Republicans voting for it. The House-passed bill includes several provisions that would be attractive to the biopharma industry, though industry groups BIO and the National Organization of Rare Disorders took issue with a provision to repeal the orphan drug tax credit, which amounts to half of all qualified ...
  • Regulatory NewsRegulatory News

    Senate Tax Plan Seeks to Reform, Rather Than Repeal, Orphan Drug Tax Credit

    The Senate’s tax plan, running counter to the House’s call to eliminate the orphan drug tax credit for research on drugs to treat rare diseases, seeks to modify the credit instead. The proposal would limit what level of expenses will qualify and limit qualified clinical expenses if they are related to the use of a drug which has previously been approved for diseases or conditions affecting more than 200,000 persons in the US. The tax credit is part of a law from...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Drug Safety, Traceability at Forefront of China’s Health Reform Plan (16 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Drug Safety and Traceability at Forefront of Healthcare Reform Program China has committed to bolstering the safety controls and traceability requirements that cover its local drug market. The commitment, which was made at a meeting of the State Council, is part of a raft of healthcare reform initiatives that are collectively intended to lessen China’s reliance ...
  • Regulatory NewsRegulatory News

    Cruz Calls for Major Overhaul of FDA

    Republican presidential candidate Sen. Ted Cruz (TX) and Sen. Mike Lee (R-Utah) on Friday introduced a bill that would completely overhaul the way the US Food and Drug Administration (FDA) operates. More specifically, the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388), or the RESULT Act,” would: allow for reciprocal approval of drugs, devices and biologics from foreign sponsors in EU member countries, Israel, Australia, Canada and Japan r...
  • 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...
  • Regulators Ask: Is FDA's Generic Drug Submission Process Broken?

    Can the quality of generic drug applications to the US Food and Drug Administration (FDA) be improved, and if so, what can regulators do to improve it? So asks FDA in a new Federal Register notice published on 22 January 2014, in which the agency notes that the completeness and quality of abbreviated new drug applications (ANDA)-the application used by generic drugs-has left something to be desired by regulators as of late. Common Problems "The Office of Generic Drug...
  • China's Communist Party Calls for Reforms to Drug Regulatory System

    China's Communist party has called for the comprehensive reform of its food and drug regulatory system in order to respond to the concerns of its people, part of a group of reforms called for at a 16 November 2012 meeting of the Communist Party of China's National People's Congress. The focus of the called-for reforms is on improving food and drug safety and the institutional regulatory mechanisms that are tasked with that mandate, explained China's State Food and Drug A...
  • New Bill Would Subject Regulations to Quadrennial Legislative Review

    A new bill proposed in the US House of Representatives would require the Office of Information and Regulatory Affairs (OIRA) to compile a report every four years recommending certain regulatory reforms to replace "outmoded, duplicative, ineffective or excessively burdensome" regulations. The bill, the Regulatory Reform Act of 2012 , would also require OIRA to compile a "list of recommendations to consolidate, modify, simplify or repeal" the regulations identified in i...
  • House Committee to Vote on User Fee Bill, Aiming for Passage in July

    The US House of Representatives' Energy and Commerce Committee is set to hold a vote on Thursday, 10 May on a collection of user fee legislation being dubbed the Food and Drug Administration (FDA) Reform Act of 2012 . The bill would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act , authorize the Generic Drug User Fee Act and the Biosimilars and Interchangeable Products User Fee Act , and make a number of reforms to FDA's review...