• Regulatory NewsRegulatory News

    Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

    The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can now rely on the inspections in each of those countries, reducing the need for duplicative work.   A total of 19 member states in the EU are now qualified by FDA as having the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. However,...
  • 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...
  • Regulatory NewsRegulatory News

    EMA and FDA to Begin Sharing Commercially Confidential Information

    Editor's note: this article has been updated with a statement from FDA clarifying that the agency must sign a confidentiality agreement with each EU country before unredacted inspection reports may be shared. As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will soon share non-public and commercially confidential information, including trade secret information. The a...
  • Regulatory NewsRegulatory News

    US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections

    After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic. Originally part of the Transatlantic Trade and Investment Partnership discussions under President Barack Obama , the agreement will allow US and EU regulat...
  • Regulatory NewsRegulatory News

    Updated: TTIP on Thin Ice Not Likely to Delay US-EU Mutual GMP Recognition Deal

    A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU will not be delayed, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions. Despite the TTIP pause, a spokesman from the EU ambassador told Focus  via email on Thursday evening ...
  • Regulatory NewsRegulatory News

    EU, Japan to Share More Information on GMP Inspections

    The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan. The agreement follows the exchange of letters on 13 September 2016 in which Japan’s Pharmaceutical Safety and Environmental Health Bureau of ...
  • Regulatory NewsRegulatory News

    FDA, Health Canada Look to Implement Common Electronic Submission System

    As part of efforts to further align the US Food and Drug Administration (FDA) and Health Canada, both sides are working to implement a common electronic submission gateway to allow pharmaceutical companies to submit large electronic documents simultaneously to both regulators. The collaborative effort is just one of a number of joint action plans the two sides are planning as part of the Canada-US Regulatory Cooperation Council (RCC), which aims to increase collaboratio...
  • Regulatory NewsRegulatory News

    Updated: FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are making significant progress toward mutually recognizing each other’s good manufacturing practice (GMP) pharmaceutical inspections. The news of the progress comes as both agencies continue to observe their counterparts’ inspections on an ongoing basis. Emer Cooke, head of international affairs at the EMA, told Focus in an exclusive interview that both sides have “progressed quicker than w...
  • 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...
  • RAPS' LatestRAPS' Latest

    Outstanding Contributions Deserve Outstanding Recognition

    Nominations are now open for RAPS awards, which go to regulatory professionals with diverse, global backgrounds. The RAPS Awards Committee is currently seeking nominations for RAPS' annual awards honoring outstanding regulatory professionals in the healthcare products sector. RAPS' awards programs provide an important opportunity to acknowledge outstanding individual contributors to the regulatory field. This year, the committee has made significant improvements to the...