Industry news

• EMA Updated Progress in New Veterinary Medicines Regulation Implementation

  26 September 2019 GMP News

  EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022.

• Survey Showed Only 27%-Readiness for EU MDR

  26 September 2019 GMP News

  A new RAPS/KPMG survey of more than 200 medical device industry leaders found that only 27% said they will be fully compliant with the new EU Medical Devices Regulations (MDR) set to go into effect 26 May 2020. Almost half of the respondents also said they will likely discontinue or withdraw medical devices from the market because of the new regulation, and about half also said they will leverage the MDR’s transitional provisions to continue to sell their current devices in the EU through 2024 while working on their compliance programs.

• Standard Form of Agreement on Connecting to State Information System Approved

  25 September 2019 GMP News

  The standard form of the agreement on connecting to the state information system for monitoring the circulation of goods subject to mandatory labeling by means of identification has been approved. Order of the Ministry of Industry and Trade of the Russian Federation of July 08, 2019 No. 2403 was registered by the Ministry of Justice on September 20, 2019 No. 55983 and published on the official Internet portal of legal information publication.pravo.gov.ru.

• Drone to Deliver Drugs to Remote Indian Areas

  24 September 2019 GMP News

  California-based Zipline will provide on-demand medical assistance through its drone delivery service in India, with the aim to provide instant aid to remote areas. Access to the right medication at an appropriate time has been a struggle in remote locations. But now there’s hope. After successfully providing on-demand medical assistance in Rwanda and Ghana through the world’s first and only national-scale drone delivery service technology, California-based automated logistics company Zipline is now setting up operations in India.

• EMA’s CHMP Recommended for Approval Seven New Medicines

  24 September 2019 GMP News

  EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2019 meeting. The Committee recommended granting a marketing authorisation for Xospata* (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. AML is a rare type of cancer of the white blood cells (cells that fight infections). It affects approximately 1 in 10,000 people in the European Union. Xospata was reviewed under EMA’s accelerated assessment procedure, reserved for medicines of major public health interest.

• FDA Presented Guidance on Child-Resistant Packaging

  24 September 2019 GMP News

  The FDA published new guidance on Child-Resistant Packaging. The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include child-resistant packaging statements in their drug product labeling.

• Russia’s Ministry of Health Announced Duty for Examination of Drugs Registration Application

  23 September 2019 GMP News

  The state duty for the examination of documents submitted to determine the possibility of state registration of a medicinal product for medical use with the establishment of post-registration measures was proposed to be established by the Russian Ministry of Health. The document is published on the regulation.gov.ru portal.

• The Oncology Drug Pathway: Getting Medications From the Pharmacy to the Patient

  23 September 2019 Jennifer Barrett / Pharmacy Time

  Despite advances in cancer care, patients typically face obstacles to treatment. Navigating these barriers on the oncology drug pathway is complex and requires specialty pharmacists to be proactive.

• Product Development: The Optimizer’s Curse

  20 September 2019 Gary Summers / Pharmaceutical Exaeutive

  Over the past eight years, the ROI of late-stage development investments, estimated for 12 large-cap pharmaceutical companies, declined from 10% to 2%.¹ Certainly, companies are not advancing compounds that they forecast to return a measly 2%. When evaluated after Phase II clinical trials, the advancing compounds looked like champions, with some of them even booked as blockbusters; so why did they arrive downstream as duds?

• Pharmacists for Healthier Lives Encourages Immunization Education

  19 September 2019 Jill Murphy / Pharmacy Time

  Pharmacists for Healthier Lives (PfHL) has launched a new campaign aimed at educating the public on the importance of immunizations to maintain a healthy population. The organization aims to raise the profile of pharmacy as an essential health care profession in the industry.