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    EMA to Continue to Allow Patient Involvement in CHMP Meetings

    The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before its Committee for Medicinal Products for Human Use (CHMP). In addition to continuing to invite patients to oral explanations on a case-by-case basis, EMA will also look to use additional methods and consult patients on a more regular basis. "This could include participating in CHMP discuss...
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    Impact of the Revised EU Clinical Trial Regulation

    Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulat...
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    GAO Survey of State Regulation of Drug Compounding Offers Mixed Results

    Among the local drug compounding regulators for 50 states, Washington, DC, Guam, Puerto and the US Virgin Islands, many say they are working with and appreciate the help of the US Food and Drug Administration (FDA), but only seven out of 50 respondents could differentiate all data on drug compounding for human use versus animal use. Building on a 2016 report , the new survey  results released by the US Government Accountability Office on Friday on the state regulatio...
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    MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU

    The following article represents the views and interpretations of the author and do not necessarily reflect those of RAPS: This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR. Introduction Both the MDR: the EU Medical Device Regulation, 2012/0266 (COD) and ...
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    Asia Regulatory Roundup: India Applies Price Controls on Stents (21 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Prevalence of Substandard Drugs in India’s Supply Chain Prompts Regulatory Proposals The Indian Ministry of Health has recommended increasing regulatory oversight of government facilities after a survey found 10% of drugs in the state supply chain are substandard. That figure is seven percentage points higher than at retail outlets, raising concerns the government is ...
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    EU Parliament Committee Backs Report to Increase Access to Medicines

    The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Tuesday backed a draft report calling on the commission to analyze the impact of intellectual property on pharmaceutical access, as well as review the regulatory framework for orphan medicines, among other provisions. The draft , which a spokeswoman for the European Parliament told Focus that a final version will be made public by the end of this week, covers a menagerie of differ...
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    Italian Medicines Agency Cites Brazilian Drugmaker for GMP Violations

    The Italian Medicines Agency (AIFA) has banned the supply of certain drugs made by Antibioticos do Brasil (ABL) following an inspection of the company's San Paulo, Brazil facility in December. In total, AIFA cites the company for four critical and seven major deficiencies, including inadequate maintenance and cleaning; poor levels of training and awareness of good manufacturing practices (GMP); and insufficient environmental monitoring. As a result of the findings, AIFA...
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    ANSM Says Pilot for New Clinical Trials Regulation Enforcement a Success

    France's Agency Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) on Wednesday reported positive results for its year-long pilot for assessing clinical trials using the process established in the new EU Clinical Trials Regulation . Background In 2014, Regulation (EU) No. 536/2014 , known as the new Clinical Trials Regulation , was adopted. The goal of the regulation is to provide faster, more coordinated assessments for clinical trial applications t...
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    International Generic Drug Regulators Outline Plans for Collaboration Through 2020

    As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years. Strategic priorities for the consortium include establishing a framework for sharing assessment-related information between regulators, promoting convergence of technical and data requirements and increasing the alignment of administrative and regula...
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    Danish Regulator Suspends Parallel Importer's GMP Certificate

    The Danish Medicines Agency has suspended Danish parallel importer Europharma DK's manufacturing authorisation and good manufacturing practice (GMP) certificate over "serious breaches of compliance" uncovered during an inspection of the company's Esbjerg, Denmark site last month. According to Europharma DK's website, the company specializes in parallel import of drugs from other EU countries that it repackages and distributes in Denmark, Germany and Sweden. However, the...
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    European Commission Clears up Questions on Orphan Drug Regulation

    Following a public consultation in November 2015, the European Commission (EC) has released a new communication intended to clarify some lingering questions about the EU's Orphan Regulation . The consultation sought to address five issues that have arisen since the Orphan Regulation came into effect in January 2000: Clarifying the meaning of "significant benefit" How to apply the Orphan Regulation to emerging diseases, such as Ebola, that are not present within...
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    EMA Offers New Guidance on Type II Variations and MA Extensions of Orphan Drugs

    The European Medicines Agency (EMA) has updated its post-authorization guidance on how extensions of marketing authorizations and type II variations may impact orphan-designated medicines. The updates follow the publication of a new  notice by the European Commission on the application of Articles 3, 5 and 7 of Regulation (EC) No. 141/2000 on orphan medicinal products . In this notice, the European Commission provides guidance on the application of the Orphan Regulation,...