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  • Feature ArticlesFeature Articles

    An overview of upstream manufacturing process and process controls for biologics drug substance: A cytokine case

    This article provides an overview for writing up the biological drug substance manufacturing process and process controls. The authors provide an example for the manufacturing of biological drugs consisting of a cytokine. They cover several complex manufacturing steps and details expected to be included in Section 3.2.S.2.2 (Description of Manufacturing Process and Process Controls) of the Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Us...
  • Regulatory NewsRegulatory News

    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
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    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...
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    Small Biopharma Face Distinct Challenges: FDA Official and Sanofi Genzyme SVP Argue

    Small biopharmaceutical companies, often known as the drivers of innovation, face a number of unique challenges in bringing new treatments, particularly for rare diseases, to market, Richard Moscicki, deputy director for science operations at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, and P.K. Tandon, senior vice president of Sanofi Genzyme, wrote. In an article published Tuesday in the New England Journal of Medicine , the a...
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    The Measure of Quality

    This article details how regulatory professionals can measure the quality of the outputs generated from the quality department. Additionally, the terms Quality Assurance (QA), Quality Control (QC) and quality management are often erroneously used interchangeably. Included are details about how these terms differ. So often we hear about how important quality is and that companies take pride in their quality or are focused on quality. It is one thing to suspect or to try...
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    Company Calls on FDA to Speed Authorization of Genetically Modified Mosquitoes to Fight Zika Virus

    As the US Food and Drug Administration (FDA) continues to debate whether to allow Britain’s Oxitec to release genetically modified mosquitoes into Florida and other vulnerable areas as a means of controlling the spread of the Zika virus, the company’s CEO told a House committee Wednesday that time is running out. Oxitec CEO Hadyn Parry, who testified before the House Committee on Science, Space and Technology, told the representatives that the company’s GM mosquito is sa...
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    Antipsychotic Label Updated With New Impulse-Control Side Effects

    • 03 May 2016
    The US Food and Drug Administration (FDA) on Tuesday warned that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of Otsuka’s antipsychotic drug aripiprazole (brand names include Abilify, Abilify Maintena, Aristada) or generic versions from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals. “These uncontrollable urges were reported to have stopped when the medicine was disconti...
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    Health Canada Makes New Transparency Pledge

    Over the next three years, Health Canada says it will enhance its early warning systems on drug and device safety issues, particularly those in other countries, further communicate explanations for regulatory decisions and update and expand guidance on regulatory requirements. The plan, laid out by the agency this week, also points to the need for more inspections of pharmaceuticals, medical devices and other health product businesses that it regulates. Building off of...
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    Registration Procedures for Medicinal Products in China

    This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...
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    New Bill Directs FDA to Pull Bayer Birth Control Device

    In an unprecedented move, Rep. Michael Fitzpatrick (R-PA) on Wednesday unveiled a new bill that directs the US Food and Drug Administration (FDA) to withdraw from the market Bayer’s birth control implant Essure. The safety of the implantable device, which is used for permanent birth control, has been called into question recently, with FDA holding an advisory panel meeting on the device's safety in September. Rep. Rosa DeLauro (D-CT) also requested FDA pull the produc...
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    FDA Bans Imports From Major Indian API Manufacturer

    The US Food and Drug Administration (FDA) on Wednesday added Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, to a list of foreign manufacturing sites banned from sending products to the US. Megafine, which was hit with an FDA Form 483 back in May at the site, produces 24 APIs for the US market , including for drugs intended to treat Alzheimer's disease, depression, schizophrenia, multiple sclerosis and over...
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    European Regulatory Roundup: CHMP Updates Breast Cancer Guidelines (15 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Updates Data Quality Control, IT Papers as Introduction of New Process Nears The European Medicines Agency (EMA) has updated documents on data quality control and electronic filings ahead of the introduction of a new process in November. EMA will start using the new process on 4 November, at which time the regulator will start sending out alerts every time it vali...