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

 
  • Regulatory NewsRegulatory News

    US and EU Fully Implement Mutual Agreement on GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities. In addition to helping reduce redundancies in manufacturing inspections, the implementation of the Mutual Recognition Agreement (MRA) means that beginning Friday, pharmaceutical companies can sto...
  • Regulatory NewsRegulatory News

    Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA

    Switzerland’s medical technology lobbying group issued recommendations to manufacturers Thursday to prepare for different possible regulatory scenarios because of uncertainty with the Institutional Agreement between the EU and Switzerland (InstA). Stalling the InstA “directly affects the medical technology sector,” said Swiss Medtech. The group noted challenges with not knowing whether support for the InstA will be voiced and whether Switzerland and the EU’s Mutual Reco...
  • Regulatory NewsRegulatory News

    Poland, Slovenia Added to GMP Agreement Between US and EU

    Earlier this month, the US Food and Drug Administration (FDA) confirmed the capabilities of Poland and Slovenia to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. FDA can now rely on a total of 22 member states to replace their own inspections, although the European Medicines Agency (EMA) notes that imported products still need to be batch tested until FDA recognizes all EU member states' authorities for human pharmaceuticals. ...
  • Regulatory NewsRegulatory News

    US, EU Pledge to Cooperate on UDI Specifications

    The US and EU will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will develop a bilateral test of compatibility of respective UDI databases, according to the interim report on the work of the US-EU Executive Working Group (EWG) on trade. The report said such cooperative work will be in concert with ongoing efforts from the International Medical Device Regulators Forum (IMDRF), which consulted on UDIs in 20...
  • Regulatory NewsRegulatory News

    EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

    Though the European Medicines Agency (EMA) and Canada have had a mutual recognition agreement (MRA) in operation since February 2003, both sides announced Monday that they may further strengthen their ties. On Friday, the European Commission’s DG Sante, EMA and Health Canada held the first Joint Sectoral Group (JSG) on Pharmaceuticals, which is a specialized committee established under the Committee on Trade in Goods of the Comprehensive Economic and Trade Agreement (CE...
  • Regulatory NewsRegulatory News

    FDA to Recognize 8 EU Regulators to Conduct GMP Inspections

    The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The announcement follows the creation of a mutual recognition agreement between the US and EU last March as part of a more collaborative approach to drug ma...
  • EU, Japanese Regulators Launch Expanded GMP Mutual Recognition System

    EU and Japanese regulators are for the first time beginning to share good manufacturing practice (GMP) data between one another in limited cases, the European Medicines Agency (EMA) announced on Monday (7 October 2013). At present, most global regulators receive data regarding not just the drug product for which a company seeks approval, but information on the way in which it will be manufactured as well. Regulators generally take that information and use it to assess th...
  • Trade Group Calls for Mutual Inspection Regime to Safeguard API Supply Chain

    • 13 November 2012
    The European Fine Chemical Group (EFCG) , an industry association of chemical manufacturers-including more than 150 devoted to pharmaceutical manufacturing-is calling for mandatory inspections of all global active pharmaceutical ingredient (API) manufacturing sites through the use of mutual recognition agreements. In a 12 November statement, EFCG said it was, "Proposing a global harmonization of the rules and regulations governing the manufacture of APIs to level the wo...
  • FDA Looks to Establish Patient Registry to Assess Risks of Imaging Contrast Agents

    • 17 July 2012
    The US Food and Drug Administration (FDA) has announced its intent to establish a new patient registry to assess the postmarketing risks of several contrast agents used in magnetic resonance imaging and angiography (MRI/MRA). In an 18 July posting in the Federal Register , FDA noted six of the eight gadolinium-based contrast agents (GBCAs) used in MRIs and MRAs are associated with nephrogenic systemic fibrosis (NSF)-a condition that causes excessive connective tissue ...