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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Backs Plan to Create Database of Off-Label and Experimental Treatments The United Kingdom government has thrown its weight behind legislation that would result in the creation of a database of innovative treatments being carried out by doctors in England, including both off-label uses of existing drugs and tests of unlicensed, experimental therapies. Official...
  • 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

    Are Biotechnology Products Safe for the Environment? FDA's New Policy Asks for Data

    While the US Food and Drug Administration (FDA) may be primarily concerned with what medicinal products do to the human body, a lesser-known secondary concern of regulators is what a product will do to the environment. Background Under 21 CFR 25.40 of the  Code of Federal Regulations , most pharmaceutical and biotechnology companies are required to submit an Environmental Assessment (EA) when submitting a new drug for approval. The assessments are meant to show how a...
  • Regulatory NewsRegulatory News

    From Gatekeeper to Facilitator: MHRA Touts Innovation Efforts

    Regulatory agencies are often seen by industry as gatekeepers, preventing products from reaching market until after they pass rigorous trials. But in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is trying to position itself as something else, in part: a facilitator. An example is a new case study issued by MHRA in which the agency describes how it was able to help bring a novel vaccine delivery mechanism developed by the University of Oxfo...
  • Regulatory NewsRegulatory News

    EMA Touts Big Year for Veterinary Products

    The European Medicines Agency (EMA) recommended 20 new veterinary medicines for approval in 2014, the highest number in the past five years, according to data provided by the regulator. The agency also boasts that it received 29 requests for classification of medicines intended for rare diseases or species with a small population, the most the agency has seen in a single year. Addressing Rare Diseases in Animals In 2009, EMA’s Committee for Medicinal Products for Vete...
  • Survey of Americans Show Trust in Big Pharma Only Slightly Above Faith in Existence of 'Lizard People'

    • 05 April 2013
    Americans don't particularly trust the pharmaceutical industry. But the extent to which that trust deficit exists is on particularly glaring display in a new survey, which shows that more than one in seven Americans think the pharmaceutical industry is colluding to "invent" new diseases in order to profit off them, and 20% erroneously think vaccines cause autism. Survey Results The survey, conducted by the group Public Policy Polling, approached 1,247 registered voters,...
  • Indonesian Pharmaceutical Industry Cries Foul over Potential New Dietary Law

    • 05 November 2012
    Vaccine manufacturers routinely have to deal with the difficulty of meeting science-based regulations. Such manufacturers operating in Indonesia may soon have another, and far more difficult, set of regulations to meet: Muslim dietary law, known as halal. UPI reports Indonesia's legislature is considering a measure that would require all pharmaceutical and biological products manufactured in the country to comply with Muslim dietary law, which includes a prohibitio...
  • Regulatory Transparency Measures Lead to False Alarms

    What happens when regulatory databases are made easier to access and understand? In at least one instance of irony, just the opposite of what might be expected. Australia's Therapeutic Goods Administration (TGA) on 1 August 2012 sent out a media advisory after receiving what it said were reports of a news story indicating influenza vaccines were unsafe. Quite the contrary, said TGA. "In fact, there have been no recorded deaths from influenza vaccine in Australia," regu...
  • New FDA Program Aims to Develop New Approaches to Clinical Trials, Pharmacovigilance

    A new program announced by the US Food and Drug Administration aims to strengthen global regulatory capacity by working with the World Health Organization (WHO) to support new, innovative approaches to clinical trial designs for vaccine products and postmarketing pharmacovigilance. "Adequate regulatory oversight throughout the vaccine development life cycle is essential in assuring the safety, purity, and potency of vaccines and other biological," said FDA's Center for B...
  • Report: FDA Increasingly Playing Key Role in Global Health

    A report issued by the Global Health Technologies Coalition (GHTC), a coalition of 40 non-profit groups including the Bill & Melinda Gates Foundation, argues that the US Food and Drug Administration's (FDA) effects are being felt far beyond US borders. The US health regulatory agency's statutory mandate is ostensibly to ensure the safety and effectiveness of products used by American consumers, but it is "increasingly…playing a role in global health R&D,...