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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Opens Door to Foreign Clinical Trial Data to Accelerate Drug Approvals China is planning to accept data generated from clinical trials run overseas. The proposal is part of a suite of changes put forward by the State Council to boost China’s support for innovative drugs and devices and accelerate their path to patients. The State Council broke its proposals up i...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese API Manufacturer for a Lack of Written and Quality-Related Procedures

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to China-based active pharmaceutical ingredient (API) manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory for, among other issues, failing to have written procedures on its handling of raw materials. FDA noted, "When our investigator asked for a list of your critical raw materials and your sampling requirements, you told our investigator that you had no writte...
  • Regulatory NewsRegulatory News

    WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site

    A Chinese manufacturer of the active pharmaceutical ingredient (API) for the birth control drug levonorgestrel has been placed on the US Food and Drug Administration’s (FDA) import alert list, causing the World Health Organization (WHO) to scramble to find a replacement. "At the moment, there is no alternative levonorgestrel API which has been prequalified," WHO said Wednesday. When an API is prequalified by WHO, it can be used for the manufacture of finished pharmaceuti...
  • Regulatory NewsRegulatory News

    New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India

    The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March. The letter for Talegaon Dabhade, India-based Badrivishal follows a three-day inspection from last August in which FDA uncovered that the site’s water purification system was not adequately monitored and controlled. FDA investigators also found...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March. The letter says the company used crude heparin batches that potentially were out of specification (OOS) to manufacture heparin sodium for the US market and shows that previous issues related to heparin sourced from Chinese active pharmaceutical ingredient (API) manufac...
  • Regulatory NewsRegulatory News

    FDA Finalizes Contract Manufacturer Quality Arrangement Guidance From 2013

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on contract manufacturer quality agreements. FDA said the differences between the draft from May 2013 and the final guidance focus on areas that needed to be clarified. “In particular, our revisions clarified the scope and applicability of the guidance and key terms used in the guidance. Regarding scope and applicability, we have clarified that the guidance is limited to commercial manufacturing...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers Guidance on Revised Vaccine Distribution Regulations (21 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guide to Implementing Revised Vaccine Distribution Regulations China Food and Drug Administration (CFDA) has released a guide to the implementation of its revised vaccine procurement and distribution regulations. The updated policy calls for vigilant record keeping by organizations in the supply chain and stronger regulatory oversight of each step in the pr...
  • Regulatory NewsRegulatory News

    FDA Bans Pharma, Nutraceutical and Cosmetic Imports from Canadian Company

    The US Food and Drug Administration (FDA) has added Canada's Cosmetic Manufacturers Inc. (CMI) to a list of companies that have been banned from shipping products to the US. CMI manufactures cosmeceuticals, nutraceuticals and pharmaceuticals, including a digestive enzyme therapy, according to its website . The company says it has a Drug Establishment License and owns the rights to many Drug Identification Number products under the CMI name. The updated FDA import alert...
  • Regulatory NewsRegulatory News

    Medical Device Audit Program Needs More Industry Involvement, Report Says

    A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be done, particularly in terms of attracting industry participants before the expected operational launch in 2017, a recent report says. Background Back in January 2014, the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force, launched a two-year pilot program ...
  • Regulatory NewsRegulatory News

    Cosmetic Companies, Watch Out: FDA Cracking Down on Improper Claims

    In recent years, a handful of cosmetic manufacturers have come under the harsh scrutiny of the US Food and Drug Administration (FDA) over claims their products could do far more than just change the skin’s aesthetics. Now the agency is again going after a marketer of cosmetic products, saying the company’s creams and moisturizers are more like drugs than beauty products. Background Cosmetic products are lightly regulated by US federal regulators. Unlike drugs, which mus...
  • Are Products Used to Whiten Your Teeth Drugs or Cosmetics? FDA Weighs in

    When is a tooth whitener a cosmetic, and when is it a pharmaceutical or medical device product? The question has never had a clear regulatory answer, and despite the efforts of the American Dental Association (ADA) to obtain one, the US Food and Drug Administration (FDA) says it prefers-for now anyway-a case-by-case approach. Background In 2009, the ADA submitted a Citizen Petition to FDA requesting that the agency "review and establish an appropriate regulatory class...
  • Feature ArticlesFeature Articles

    New EU Regulation on Postmarketing Surveillance of Cosmetic Products

    • 05 February 2014
    Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 1999 on cosmetic products 1 (the Cosmetics Regulation ), governing cosmetic products in the EU, came into force on 11 July 2013. A new and important aspect of the regulation concerns postmarketing surveillance to be carried out by manufacturers, importers and distributors. This article highlights the industry's responsibilities for designating a single point of contact, collecting...