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  • Regulatory NewsRegulatory News

    Three foreign OTC firms slapped with warning letters for GMP testing violations

    Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one led the US Food and Drug Administration (FDA) to issue three warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.   The recipients of the warning letters, which were all issued in mid-September, include Laboratorio Pharma International in Tegucigalpa, Honduras, a manufacturer of antibiotics and ...
  • Regulatory NewsRegulatory News

    WHO revises guidance on GMPs for investigational products, R&D facilities

    The World Health Organization (WHO) recently issued a revised draft guidance to industry addressing good manufacturing practices (GMPs) for investigational drug products as well a new draft guideline addressing GMP principles for research and development facilities in the context of the COVID-19 pandemic.   The draft guidance on GMPs for investigational products was prompted by WHO’s Prequalification Team Inspections Services (PQT), which last year expressed the need...
  • Regulatory NewsRegulatory News

    EMA updates reflection paper on GMP responsibilities of marketing authorization holders

    The European Medicines Agency (EMA) on Thursday issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission (EC) GMP guidelines and other EU legislation.   The paper replaces a draft version issued in January 2020 with only some minor revisions. (RELATED: EMA Consults on GMP Reflection Paper , Regulatory Focus, 22 January 2020).   The paper covers the re...
  • Regulatory NewsRegulatory News

    PIC/S updates GMPs for ATMPs, biological substances

    Revisions to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide addressing the manufacturing of advanced therapy medicinal products (ATMPs) as well as biological medicinal substances and products are set to go into effect 1 May.   PIC/S published the final Annex 2A and Annex 2B on 23 April after a consultation that began in September 2019. (RELATED: PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances , Regulatory Focus, ...
  • 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 ...
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    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...