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    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
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    FDA Official Highlights Foreign Supply Chain Challenges

    Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research. Speaking at the Food and Drug Law Institute's annual conference on Friday, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers, which fi...
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    Thailand's Approach to Drug Quality Assurance: Creation of the Green Book

    This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines. Regulatory System Overview Thailand's health system is regulated by the MOPH and the Thai FDA in collaboration with a number of government and independent health agencies. The MOPH is responsible for all health-relate...
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    CDER Officials: Nanomaterial Submissions on the Rise

    A team of officials from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER) say that submissions for drugs containing nanomaterials are on the rise. The finding stems from an analysis published Monday in Nature Nanotechnology , in which the officials look at trends in submissions involving nanomaterials over the last 40 years. In the analysis, the authors say the number of investigation...
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    EMA-FDA QbD Pilot Program Led to Further Harmonization

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH). Background The joint pilot program, initially launched in March 2011 for three years, was extended for two more years in 2014 to facilitate further harmonization of per...
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    Researchers Link Target Product Profiles to Shorter Review Times

    A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency. The analysis was published in Cell Press earlier this month by Christopher Breder, a medical officer within FDA's Office of New Drugs and adjunct faculty at Johns Hopkins University's regulatory science program and two students in the program, Wenny Du and Adria Tynd...
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    Industry Wants FDA to Hit the Brakes on Quality Metrics Program

    The US Food and Drug Administration's (FDA) proposed quality metrics program is proving to be a bitter pill for the pharmaceutical industry to swallow. Months after FDA revised its draft guidance in response to industry concerns, a consortium of industry groups, including the Association for Accessible Medicines (AAM, formerly GPhA), the Pharmaceutical Research and Manufacturers of America (PhRMA), International Society for Pharmaceutical Engineering (ISPE), Bulk Pha...
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    International Generic Drug Regulators Unveil New Biowaiver Assessment Template

    Regulatory authorities participating in the International Generic Drug Regulators Programme (IGDRP) have crafted and released a Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template for use by its members. IGDRP, which is made up of regulators from all over the world including the US Food and Drug Administration, Health Canada, European Medicines Agency and China Food and Drug Administration, among others, created its Bioequivalence Working G...
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    EMA Weighs New Guideline on Quality Requirements for Combination Products

    The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product. EMA says the guideline will consider the data requirements with respect to quality aspects in relation to the safety and performance of the medical device, whether it is an integral component of the medicinal product or a stan...
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    FDA Warns of Risks From Fluid-Filled Stomach Balloons to Treat Obesity

    The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers noting the receipt of dozens of reports for two different types of adverse events linked to fluid-filled intragastric balloons used to treat obesity.  “The first type of adverse event involves the fluid-filled intragastric balloon over-inflating with air or with more fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need for premature device removal...
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    CDRH Warns Three Foreign Medical Device Manufacturers

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea. Among other violations, the warning letter for Taiwan-based HMD Biomedical, which manufactures GoodLife AC 300-305 Self-Monitoring Blood Glucose, says the company did not establish and maintain procedures for validating the device’s design, nor did it provide trainin...
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    When Can Drugmakers Cite Quality Standards From Foreign Compendia? FDA Explains

    An updated Manual of Policies and Procedures (MAPP) for the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lays out when drug sponsors and applicants can propose specifications for excipients, drug substances and drug products in their applications based on quality standards in the British Pharmacopoeia (BP), the European Pharmacopoeia (EP) or the Japanese Pharmacopoeia (JP). Updated from 2007 and 2014 versions, the MAPP says that such ci...