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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Introduces Tougher Regulations on Homeopathic Medicines (20 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australian Generic Medicine Work-Sharing Trial Misses Completion Target A work-sharing group involving Australian regulators has reported the results of its first collaborative assessment of a generic medicine. The review of the filing took about nine months, four months longer than the collaborators had targeted at the start of the project. Officials from Australia’...
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    FDA Warns Chinese Firm for Confusing API in OTC Drug

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last Monday to China-based Guangdong Zhanjiang Jimin Pharmaceutical Co. after finding that one of the over-the-counter drugs the firm made was labeled as containing the active pharmaceutical ingredient (API) hydrocortisone, but really the drug contained dexamethasone acetate. The company told FDA that the mix-up is the result of "a translation mistake," according to the warning letter...
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    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...
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    Asia Regulatory Roundup: CFDA Seeks Feedback on Guidance for Medical Device Clinical Trial Sites (8 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Moves to Block Manipulation of Stent Margins, Advance Knee Implant Price Probe The National Pharmaceutical Pricing Authority (NPPA) of India has revised its rule on the pricing of coronary stents to stop manipulation of profit margins. NPPA’s addendum clarifies the definitions of “manufacturer” and “distributor” and prohibits that latter from making margins of mo...
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    Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Starts Accepting Priority Review Notifications, Implements Revised Orphan Drug Program The Therapeutic Goods Administration (TGA) of Australia has opened its priority review pathway. TGA is now accepting notifications from sponsors who plan to apply for priority review status to accelerate the approval of their medicines in the coming months. Officials at TGA are ...
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    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...
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    Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Forms Leadership Group to Reform Drug Pricing Legislation, NPPA India has convened a committee to consider reforms to drug pricing legislation and the agency that enforces the rules. Officials at the Department of Pharmaceuticals took the step in response to feedback from regulators and industry about the shortcomings of the existing pricing legislation and mech...
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    House Committee Asks FDA for More Info on Contaminated Heparin Investigations

    Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed. In 2007 and 2008, heparin sourced from Chinese manufacturers was linked to the deaths of nearly 150 Americans. Questions of contamination resurfaced last year when French regula...
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    China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications

    China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday. At least part of the problem stems from the fact that CFDA uses “an overly strict approach” for approving clinical trial applications, which contrasts with a...
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    CDRH and CDER Send Warning Letters to Six Asian Companies

    The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan. The most recent letter, sent from FDA’s Center for Drug Evaluation and Research (CDER) to Bangalore, India-based active pharmaceutical ingredient (API) manufacturer Resonance Laboratories on 3 February, following a four-day inspection last May, says in...
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    Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown

    A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety. Back in 2008, FDA opened its first foreign offices as part of its res...
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    FDA Warns Chinese Drugmaker for Refusing Inspection, Unsanitary Conditions

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 8 December to China-based Baoying County Fukang Medical Appliance with six violations. During the June inspection, FDA says its inspector asked a company representative to “explain the microbiological testing processes” for products manufactured and distributed in the US from the plant, but the representative said that information is protected as a trade secret. “Our investigator expla...