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    FDA Issues Delayed DSCSA Grandfathering Guidance

    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA). While the guidance comes two years after the deadline set by the DSCSA and on the same day that requirements for manufacturers to begin affixing or imprinting product identifiers on packages and homogenous cases ...
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    European Commission Adopts Two Acts on GMPs for Medicines

    Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use. One of the acts is an  implementing directive  that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization ( see Article 40 of the Community code Directive (2001/83/EC) ). The ...
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    FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors

    The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May. According to FDA, the firm's management admitted to falsifying analytical test results used to release a lot of its products to the US. In another instance, FDA says the firm reported that a batch of one of its products was within specification ...
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    FDA Offers Draft Guidance to Further Secure Drug Supply Chain

    The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013. Background The DSCSA outlines the path to better secure the US drug supply chain via an electronic, interoperable system by 2023 to track and trace certain prescription drugs as they are distributed. The law helps FDA ensur...
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    FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings

    The US Food and Drug Administration (FDA) on Wednesday announced it plans to launch a pilot program aimed at exploring issues related to the interoperable electronic system for drug tracing required under the Drug Supply Chain Security Act (DSCSA) by 2023. The agency also announced that it will hold a series of public meetings on DSCSA-related issues in August 2017, December 2017 and February 2018. At the meetings, FDA says it plans to discuss issues ranging fr...
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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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    Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration

    With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion. The new toolkit, born out of a five-year collaborative project that actually took four years to complete, brings expertise from the US Pharmacopeial Convention (USP), US Food and Drug Admin...
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    Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes Electronic Platform to Monitor Drug Supply Chain The Indian government is proposing to create an electronic platform to monitor the drug supply chain. Officials want all manufacturers, distributors and pharmacies to register on the platform and upload details of batches they supply and receive in an attempt to raise drug standards in India. India’s Mini...
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    Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs

    The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs). "By lowering the GMP requirements for ATMPs, the European Commission is not only exposing patients to an increased risk t...
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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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    FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section

    The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate. Under the new section, which FDA says is being distributed “for comment purposes only,” the agency offers its interpretation of Section 582(b)(4)(B)(ii)(II) of the Food, Drugs and ...
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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...