• Regulatory NewsRegulatory News

    New laws address NCE exclusivity, biosimilar education

    Two bipartisan bills aimed at clarifying what constitutes a new chemical entity (NCE) and providing education on biosimilars to consumers and physicians were signed into law by President Joe Biden on Friday.   The first bill, S. 415 , also known as the Ensuring Innovation Act , amends the Federal Food, Drug, Cosmetic Act (FD&C Act) to replace the definition of an active ingredient with the active moiety definition used by FDA for the purposes of determining whether...
  • Regulatory NewsRegulatory News

    Swissmedic Touts 2016 Performance: 42 New Approvals

    In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in approving new drugs in 2016, in part due to the agency's new fast-track procedure. In 2016, Swissmedic approved 42 new active substances (NASs), a 50% increase over the previous year and just over 50% more than EMA recommended. "This increase shows that the pharmaceutical industry in Switzerland is conti...
  • Feature ArticlesFeature Articles

    EU and US Regulations for Chemical Components in Medical Devices

    This article discusses a number of regulations directed at the use of chemical components in medical devices, both in the EU and US. The author reviews legislation, offers compliance advice and warns about the penalties of noncompliance. Introduction When a healthcare provider purchases a new medical product, the purchaser has the same high expectations for long-term reliability and performance that any business has when investing in new equipment. While consumer elec...
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    FDA Warns Japanese Company for Impeding Inspection

    The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December. According to FDA, Nippon Fine Chemical employees physically blocked an FDA investigator from conducting portions of the inspection, refused to hand over records and prevented FDA from taking photographs of eq...
  • Regulatory NewsRegulatory News

    Obama Signs Chemical Safety Bill Into Law

    President Barack Obama on Wednesday signed into law a bill that will overhaul, for the first time in 40 years, the way chemical substances are regulated in the US. Although the new law, which updates the Toxic Substances Control Act of 1976, deals with regulations governed by the Environmental Protection Agency (EPA) rather than the US Food and Drug Administration (FDA), it integrates principles to replace and reduce animal-based tests with human-relevant methods to asse...
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    EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record

    In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014 , granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17. Notably, EMA trailed just behind the US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) for the year. In 2015, CDER approved 45 new drugs, 21 of which had been granted orphan drug designati...
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    FDA: Explosions at Chinese Chemical Warehouse Contaminated Drugs

    The US Food and Drug Administration (FDA) on Tuesday alerted compounders and drug manufacturers that shipments from Tianjin, China may be at risk of chemical contamination following two massive explosions in August at a chemical warehouse there. The agency has already detected hydrogen cyanide contamination in two shipments of drugs from Tianjin-based Tianjin Tianyao Pharmaceuticals Co., approximately 30 kilometers (18 miles) from the explosion site. The contaminated sh...
  • Regulatory NewsRegulatory News

    New Fixed-Dose Combination Drugs Now Eligible for 5 Years of Exclusivity, FDA Says

    The US Food and Drug Administration (FDA) has finalized a new policy which will for the first time allow new fixed-dose combination  (FDC) drugs consisting of at least one new drug product to be eligible for five years of so-called "New Chemical Entity" (NCE) exclusivity. But in a setback for companies with existing FDCs, the agency will not apply the policy retroactively. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from...
  • Trade Group Calls for Mutual Inspection Regime to Safeguard API Supply Chain

    • 13 November 2012
    The European Fine Chemical Group (EFCG) , an industry association of chemical manufacturers-including more than 150 devoted to pharmaceutical manufacturing-is calling for mandatory inspections of all global active pharmaceutical ingredient (API) manufacturing sites through the use of mutual recognition agreements. In a 12 November statement, EFCG said it was, "Proposing a global harmonization of the rules and regulations governing the manufacture of APIs to level the wo...
  • FDA Looks to Regulatory to Plan for Potential Mass Casualty Event

    Are US regulators prepared to deal with a mass casualty incident involving burns caused by a radiological, nuclear or chemical device? The question is the focus of an upcoming meeting sponsored by the US Food and Drug Administration (FDA), which said it is looking to assess how to promote burn treatment products to fill "gaps in the product landscape," and determine which regulatory pathways and testing methods best fill those gaps. The meeting is a part of a program ...
  • ICH Finishes Q11 Quality Manufacturing Guideline, Prepares to Notify Regulators

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced 11 May it has finished worked on its Q11 quality drug manufacturing guideline and is preparing to notify various international regulatory bodies so they can implement the guideline. ICH said its Q11 guideline, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities , will now b...