The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

  • RAPS' LatestRAPS' Latest

    Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery

    The following chapter is an excerpt taken from  Fundamentals of EU Regulatory Affairs, Seventh Edition . Objectives Introduce the problem of falsified medicines Define falsified and counterfeit medicines Define active substances and excipients Explain the aims and scope of the Falsified Medicines Directive ( FMD ) Directive 2011/62/EU ) Identify requirements for different stakeholders in the medicines supply chain arising from the FMD ...
  • Regulatory NewsRegulatory News

    EMA Outlines High-Level Strategy for Next Five Years

    Antimicrobial resistance, ensuring timely access to new drugs, increasing transparency and working to harmonize more regulations worldwide are all included in the European Medicines Agency’s (EMA) strategic plan through 2020. The new plan, unveiled Friday, offers 16 objectives around four themes: Contributing to human health, contributing to animal health and human health in relation to veterinary medicines, optimizing the operation of the network and contributing to th...
  • Regulatory NewsRegulatory News

    UK Patients With NSCLC to get Early Access to Tagrisso

    Patients in the UK with a specific form of non-small-cell lung cancer (NSCLC) will get early access to AstraZeneca's Tagrisso (osimertinib), following a positive opinion by the Medicines and Healthcare products Regulatory Agency (MHRA). Specifically, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC will be able to access Tagrisso under the Early Access to Medicines Scheme (EAMS). EAMS was created to provi...
  • Regulatory NewsRegulatory News

    Italian Medicines Agency Finds Major Deficiencies at Radiopharmaceutical Manufacturer

    The Italian Medicines Agency (AIFA) released a non-compliance report on Wednesday for the Rome-based radiopharmaceutical manufacturer Iason Italia with deficiencies linked to quality issues. AIFA says that based on its inspection from 8 October, Iason does not comply with good manufacturing practice (GMP) requirements. This is the third GMP non-compliance report posted to one part of EudraGMDP – the European database of pharmaceutical manufacturing violations -- in rece...
  • Regulatory NewsRegulatory News

    TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

    After five years of negotiations, the release of the final text of the long-awaited trade deal, known as the Trans-Pacific Partnership (TPP), on Thursday, as well as concessions made to the US in the WTO’s TRIPS (trade-related aspects of intellectual property rights) deal announced Friday both offer new insight into the strength of the pharmaceutical industry’s lobbying and negotiating powers. TPP Early last month, a number of questions emerged over a sticking point ...
  • Regulatory NewsRegulatory News

    MHRA Proposal Would Save Industry £5M Annually in Fees

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is proposing to reduce many of the industry fees it collects by 10-15%, and it will introduce a new fee for online pharmacies to cover the cost of implementing the EU Falsified Medicines Directive. Fee Reductions Earlier this year the UK's Department of Health conducted its triennial review of MHRA. As part of the review, the Department of Health recommended MHRA revise its fees to better "align incom...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Dutch Regulator Overhauls Policy on Nomenclature of Medicines The Medicines Evaluation Board (MEB) in the Netherlands has completely revised its policy on nomenclature covering human medicinal products and is enforcing the changes with immediate effect. Out of all the revisions included in the new nomenclature policy, MEB has picked out six that it sees as the most importan...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Japanese Regulators Receive Orphan Drug Training from EMA (6 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Japanese Regulators Receive Orphan Drug Training from EMA Staffers at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have received training on orphan medicines from the European Medicines Agency (EMA). The training session was led by Dr. Segundo Mariz, a member of EMA’s Committee for Orphan Medicinal Products (COMP). Mariz has worked on the committee since ...
  • Feature ArticlesFeature Articles

    Ebola—Expedited Pathways for Drugs and Vaccines in Europe: The EMA Perspective

    This article discusses the European Medicines Agency (EMA) facilitated expedited pathways for drug and vaccine approval to enable fast access to market to fight emerging diseases, such as Ebola. To date, neither the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has approved a vaccine or therapy for the treatment of the Ebola virus, which in Guinea, Liberia and Sierra Leone has had a case fatality rate as high as 71%. 1 Regulatory a...
  • Regulatory NewsRegulatory News

    WHO: 'Critical' Data Integrity Issues Found at Indian CRO

    Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last October. Background As part of its Prequalification of Medicines Programme , WHO carries out inspections of companies involved with clinical research and manufacturing to ensure prequalified medicines are of "acceptable quality, safety and efficacy." The program focuses on prod...
  • Regulatory NewsRegulatory News

    EU Online Pharmacies Required to Display New Logo Next Month

    New rules to help consumers in the EU identify legitimate online pharmacies are set to take effect on 1 July 2015. The rules require online pharmacies operating in the EU to display a "common logo," and register with authorities in the member states they do business in. Background Recognizing the threat to public health and safety posed by falsified medicines sold online, in 2011 the European Parliament and Council adopted Directive 2011/62/EU , also known as the Fa...
  • Regulatory NewsRegulatory News

    Cancer Drugs First to Take Advantage of UK Early Access Scheme

    The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a second product under a new accelerated review process intended to make promising new drugs available to patients more quickly. The drug, Bristol Myers Squibb's Opdivo (nivolumab), joins Merck's Keytruda (pembrolizumab) as one of two products listed under MHRA's early access to medicines scheme (EAMS), both of which are intended to treat advanced melanoma. Background In March 2014, MHRA ann...