• Regulatory NewsRegulatory News

    Regulating CRISPR: FDA and Industry Offer Perspective

    Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators. What is CRISPR? According to the Broad Institute , CRISPR (pronounced "crisper") stands for Clustered Regularly Interspaced Short Palindromic Repeats, which form the basis for a genome ...
  • Regulatory NewsRegulatory News

    WHO to Craft Essential Diagnostics List

    The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL). The committee said the decision to begin developing such a list, agreed to earlier this month, may initially focus on in vitro diagnostics, with initial proposed priority areas including tuberculosis, malaria, HIV and hepatitis B and C. According to WHO , the list "should expand to other areas including other antimicrobial...
  • Regulatory NewsRegulatory News

    Application of EU Clinical Trial Regulation Delayed to 2019

    The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed. "Due to these delays, the EU  Clinical Trial Regulation  will now come into application in 2019 instead of October 2018, as previously scheduled," EMA said Friday. The agency says it will provide an update at the next meeting of the Management Board in October 2017, followi...
  • RAPSRAPS' Latest

    6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation

    When the EU’s new Medical Devices Regulation ( MDR ) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready. 1. Plan Ahead In order to figure out wh...
  • Regulatory NewsRegulatory News

    Caribbean Regulatory System Begins Recommending Generic Drugs

    The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) last month kicked off its work advising Caribbean countries’ governments by assessing and recommending four generic HIV treatments. The recommendations, which follow approval from WHO, included emtricitabine/tenofovir and tenofovir tablets, also known as generic versions of Viread and Truvada (a generic of which also recently won US FDA approval ). The regional initiative is meant to help ...
  • Regulatory NewsRegulatory News

    Australia Proposes New Risk-Based Approach to Medicine Variations

    Australia's Therapeutic Goods Administration (TGA) on Thursday released guidance on a plan to allow companies to make "very low risk" changes to registered medicines after submitting them to TGA and receiving an automated acknowledgement. "These requests are known as 'notifications' but still require an application to the TGA," the regulator explained. "These lowest risk variations do not require evaluation but legally must still be approved by the TGA before imple...
  • Regulatory NewsRegulatory News

    WHO Essential Medicines Update Adds Antibiotic use Framework and new HCV & HIV Drugs

    The World Health Organization (WHO) on Tuesday announced updates to its essential medicines list (EML), including new recommendations for antibiotic use and the addition of new drugs to treat hepatitis C, HIV and leukemia. The list, which is intended to serve as a model for the most crucial medicines for ensuring public health, is updated every other year based on recommendations from WHO's Expert Committee on the Selection and Use of Essential Medicines. "These medicin...
  • Regulatory NewsRegulatory News

    EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25

    The European Medicines Agency (EMA) on Wednesday announced that it has accepted five additional therapies to its PRIME (PRIority MEdicines) scheme, bringing the total number of products accepted to the program to 25. The agency also said it denied seven requests for eligibility, which seeks to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors. While this latest batch of recomme...
  • Regulatory NewsRegulatory News

    Challenges Providing Pharmaceutical Products to Syrian Refugees

    This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality. Introduction Providing healthcare aid to civilians during war and crisis is a complicated task. The Syrian war has impacted the healthcare system inside Syria and the neighboring countries. Large and small humanitarian organizations have wor...
  • Regulatory NewsRegulatory News

    Australia Considers Allowing the Marketing of Devices Approved Overseas

    Australia’s Therapeutic Goods Administration (TGA) on Monday released a proposal to allow for the use of devices that have received marketing approvals from select foreign authorities. TGA says its primary objective in releasing the proposal is to either: Use approvals from comparable overseas regulators as the evidence of regulatory compliance for including devices in the Australian Register of Therapeutic Goods (ARTG) (and to avoid the need for duplicate assessments...
  • Regulatory NewsRegulatory News

    FDA Officials Discuss Modernizing the Regulation of Combo Products

    As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature . Nina Hunter, FDA’s associate director for science policy, and Rachel Sherman, F...
  • Regulatory NewsRegulatory News

    UK Patients to Get Early Access to AbbVie's HCV Combo

    Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday. The combination, known as glecaprevir/pibrentasvir, is currently undergoing an expedited review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for its potential to treat patients across all six major genotypes of HCV, with or wi...