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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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    ICH Offers Reflection Paper on Good Clinical Practice Revisions

    The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct. The scope of the revisions includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice , which is already undergoing modernization with the recent de...
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    Submitting Manufacturing Establishment Info Electronically: FDA Offers Draft Guidance

    Pharmaceutical manufacturers take note: The days of non-electronic submissions of establishment information to the US Food and Drug Administration (FDA) are coming to an end, possibly as soon as 2019. On 28 December, FDA released draft guidance on the submission of manufacturing establishment information (MEI) in an electronic format. Twenty-four months after the agency finalizes this guidance, all MEI contained in new drug applications, abbreviated new drug applicat...
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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...
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    Japan Joins International API Manufacturing Inspection Program

    Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs). “PMDA has decided to join this program from 24 November 2016,” the agency said in an announcement. “The participation in...
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    Companies Producing Drugs Only for INDs Exempt From FDA Registration

    The US Food and Drug Administration (FDA) on Monday published a correction to a recent final rule on registering foreign and domestic manufacturing establishments, clarifying that a company producing solely products for investigational new drug (IND) applications is exempt from registration. The more than 200-page final rule released in late August requires the electronic submission of the registration and listing information for all drug, active pharmaceutical ingredi...
  • European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EC Appeases Some SMEs With Revised Advanced Therapy GMPs but Objections Remain The European Commission has received some favorable feedback on its draft good manufacturing practice (GMPs) guidelines for advanced therapy medicinal products (ATMPs). However, while small and medium-sized enterprises (SMEs) were broadly supportive of changes proposed in the draft, the commission...
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    FDA Warns Spanish API Maker for GMP Violations

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices (GMP) violations uncovered during an inspection of the company's Barcelona facility last May. In a warning letter, FDA cites Interquim for three issues related to its cleaning procedures, deteriorated equipment surfaces and stability testing data. According to FDA, Interquim d...
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    Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DTAB Proposes Stipulations to Indian Plan for Permanent Licenses The Indian Drugs Technical Advisory Board (DTAB) has given its conditional support to end the need to renew licenses to make, sell and test drugs. DTAB is broadly in favor of the idea, but has suggested stipulations that are more burdensome than those proposed by the Drug Controller General of India (DCG...
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    ICH Advances Three Guidance Documents

    The International Council for Harmonisation (ICH) earlier this week announced the advancement of two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase. On the Step 4 front, the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) advanced. “The current amendment (ICH E6(R...
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    ICH Looks to Revamp GCP Guidelines, Adds New Members

    Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week. Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017. "This will include updating current guidance on interventional trials and expand on...
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    FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak

    An investigation into a multistate outbreak has identified the bacteria, Burkholderia cepacia , in more than 10 lots of oral liquid docusate sodium linked directly to a contract manufacturing organization’s (CMO) Florida-based site.   PharmaTech in August voluntarily recalled all of its liquid drug formulations made at the Davie, Florida facility after being linked to the outbreak. The recall impacted products distributed and labeled by six firms – Rug...