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    FDA Warns Four Foreign Drug Manufacturers

    The US Food and Drug Administration (FDA) on Tuesday released four warning letters sent in September to drug manufacturers from China, the UK, the Netherlands and Switzerland. The warning letters are part of a wider crackdown by FDA on foreign drug manufacturers, particularly in China and India . Data manipulation has been a primary concern for FDA, in addition to trying to deal with manufacturers that refuse inspections . China For the warning letter sent 26 Se...
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    EU, Japan to Share More Information on GMP Inspections

    The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan. The agreement follows the exchange of letters on 13 September 2016 in which Japan’s Pharmaceutical Safety and Environmental Health Bureau of ...
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    Asia Regulatory Roundup: India’s DCGI Orders Manufacturers to Assess GMP, GLP Compliance (30 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Orders Manufacturers to Assess Their Compliance with GMPs, GLPs The Drug Controller General of India (DCGI) has ordered companies to self-assess their compliance with good manufacturing and laboratory practices (GMPs/GLPs). DCGI is demanding manufacturers carry out the self-assessment, award themselves a quality rating and submit the resulting report to the relev...
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    EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection

    A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators. Pfizer decided to temporarily suspend operations at the site earlier this month and MHRA is now calling on EU member states’ National Competent Authorities to evaluate how ...
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    Data Integrity: New Draft Guidance and Q&A

    The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines. The 44-page PIC/S draft guidance, known as “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments,” is focused on providing ind...
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    FDA, Health Canada Look to Implement Common Electronic Submission System

    As part of efforts to further align the US Food and Drug Administration (FDA) and Health Canada, both sides are working to implement a common electronic submission gateway to allow pharmaceutical companies to submit large electronic documents simultaneously to both regulators. The collaborative effort is just one of a number of joint action plans the two sides are planning as part of the Canada-US Regulatory Cooperation Council (RCC), which aims to increase collaboratio...
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    Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections

    • 08 August 2016
    Pfizer and Wockhardt are struggling to keep pace with pharmaceutical good manufacturing practice (GMP) regulations as two recent inspections of their manufacturing sites in India resulted in a US ban for Wockhardt and a temporary suspension of the Pfizer site. For Pfizer, the inspection of its Chennai-based site, acquired as part of its $16 billion purchase of Hospira, was a joint effort for officials from four regulators: the US Food and Drug Administration (FDA), UK’s...
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    FDA Continues Crackdown on Chinese Drug Manufacturers With new Warning for Xiamen

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs). As imports of pharmaceuticals from China and India have increased, so has FDA's enforcement of manufacturing for companies exporting to the US. In 2015, FDA carried out 132 inspections of Chinese manufacturers, more than twi...
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    Updated: FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are making significant progress toward mutually recognizing each other’s good manufacturing practice (GMP) pharmaceutical inspections. The news of the progress comes as both agencies continue to observe their counterparts’ inspections on an ongoing basis. Emer Cooke, head of international affairs at the EMA, told Focus in an exclusive interview that both sides have “progressed quicker than w...
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    MHRA Cites Pharmaceutics International for GMP Issues at Two US Sites

    The Medicines and Health Care products Regulatory Agency (MHRA) on Wednesday cited US-based contract manufacturing organization Pharmaceutics International, Inc. (Pii) for critical deficiencies at two of its Maryland facilities. In the reports, outlined in two separate statements of non-compliance published to the European Medicine Agency's (EMA) EurdraGMP database, the inspectors say they identified a "failure of organizational and technical measures to minimize the ris...
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    CFDA’s Domestic Pharma Manufacturing Site Inspections Decline Significantly

    China’s Food and Drug Administration (CFDA) in 2015 inspected less than half the number of pharmaceutical manufacturers as compared with 2014, according to a recently released annual report from the Center for Food and Drug Inspection of CFDA. The report claims that as the number of domestic inspections has decreased significantly, “the proportion of enterprises going through rectification inspection and receiving Warning Letters has significantly increased, with the rat...
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    Croatian Regulator Cites Indian Manufacturer for QA, GMP Violations

    The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) on Monday issued a statement of non-compliance to Indian active pharmaceutical ingredient (API) manufacturer Dhanuka Laboratories Ltd. The notice was issued following an inspection of Dhanuka's Gurgaon, India facility conducted on 19 February 2016, during which inspectors discovered 32 good manufacturing practice (GMP) violations, including one critical violation involving Dhanuka's "weak" quality ...