FDA and EMA Collaborate for Generic Drug Inspection Initiative

The two organizations launch a generic drug inspection initiative to support drug approvals

According to a press release from the FDA, the organization has partnered with the European Medicines Agency (EMA) to launch an initiative to “share information on inspections of bioequivalence studies submitted in support of generic drug approvals.” The joint initiative hopes to facilitate an easier process for approving generic drugs.

The inspections initiative will provide a mechanism by which both organizations can conduct facility inspections for generic drug applications that were submitted to both organizations, which allows for a quicker, more streamlined process. According to the press release, studies submitted for generic drug applications must show that a drug is bioequivalent and performs in the same manner as the name brand drug.

The initiative hopes to streamline information sharing on inspections of bioequivalence studies, share information about negative inspection outcomes, conduct joint inspections at facilities all over the world and provide training opportunities to improve inspections.

In Europe, participating counties include France, Germany, Italy, The Netherlands and the United Kingdom. 

Download Center

HTML - No Current Item Deck
  • Incident investigation guide

    Need some tips for conducting an incident investigation at work after there’s been an occupational injury or illness, or maybe even a near miss? This guide presents a comprehensive overview of methods of performing incident investigations to lead you through your next steps.

  • Steps to Conduct a JSA

    We've put together a comprehensive step-by-step guide to help you perform a job safety analysis (JSA), which includes a pre-built, JSA checklist and template, steps of a JSA, list of potential job hazards, and an overview of hazard control hierarchy.

  • Levels of a Risk Matrix

    Risk matrices come in many different shapes and sizes. Understanding the components of a risk matrix will allow you and your organization to manage risk effectively.

  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Industry Safe
Bulwark FR Quiz

OH&S Digital Edition

  • OHS Magazine Digital Edition - July August 2020

    July August 2020

    Featuring:

    • CONFINED SPACES
      Addressing Confined Spaces and Heat Stress Concerns
    • PROTECTIVE APPAREL
      Why Daily Wear FR Garments Make Sense No Matter the Season
    • HAND PROTECTION
      The Magic of New Technology
    • CHEMICAL SAFETY
      Why Effective Chemical Safety Training is More Important Than Ever
    View This Issue