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  • Regulatory NewsRegulatory News

    European Commission Adopts Two Acts on GMPs for Medicines

    Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use. One of the acts is an  implementing directive  that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization ( see Article 40 of the Community code Directive (2001/83/EC) ). The ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (11 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes to Bring GMPs up to WHO Standard, Scrap Need to Renew Licenses The Drug Controller General of India (DCGI) is proposing to bring the country’s good manufacturing practices (GMPs) up to the standard set by the World Health Organization (WHO). DCGI Dr. GN Singh unveiled the proposal alongside plans to end the need for manufacturers, sellers and testers of ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Begins Overseas Inspections (26 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Warns Indian, Japanese Manufacturers as Overseas Inspection Drive Begins China Food and Drug Administration (CFDA) has found fault with the manufacturing practices of four foreign drugmakers, the highest profile of which is India’s Aurobindo Pharma. The regulator framed the warnings as part of an initiative to step up its oversight of companies that are importing ...
  • FDA Clears Mayo Clinic to Manufacture PET Drug

    Regulators with the US Food and Drug Administration (FDA) have approved the manufacture of an existing positron emission tomography (PET) drug for use at a new facility, the agency has announced. The drug, Choline C 11 Injection, is used to help detect the presence of recurrent prostate cancer. The drug is administered to patients intravenously, and is specifically indicated for patients whose blood prostate specific antigen (PSA) levels have risen despite earlier trea...
  • Australia Planning Updated GMPs for Blood and Tissue Products

    Australia's Therapeutic Goods Administration (TGA) is beginning the process of revising its code of good manufacturing practices (GMPs) for the manufacture of blood and tissue products, the agency announced on 11 September. The revisions will eventually update TGA's August 2000 code, GMPs for Blood and Tissues , and will involve a 12-month implementation period once finalized. TGA said it anticipates making two primary revisions to the code: a revised portion dea...
  • FDA 'Aghast' at Lack of cGMP, AER Compliance by Supplement Manufacturers

    The US Food and Drug Administration's (FDA) top dietary supplement regulator said at an industry conference meeting he is " aghast at the degree of non-compliance " when it comes to current good manufacturing practices (cGMPs) and adverse event reporting (AER) in the industry, reports Nutra Ingredients USA . Speaking 25 April to a meeting convened by the Natural Products Association, Daniel Fabricant, director of FDA's Dvision of Dietary Supplement Programs, said the in...