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    WHO Essential Medicines Update Adds Antibiotic use Framework and new HCV & HIV Drugs

    The World Health Organization (WHO) on Tuesday announced updates to its essential medicines list (EML), including new recommendations for antibiotic use and the addition of new drugs to treat hepatitis C, HIV and leukemia. The list, which is intended to serve as a model for the most crucial medicines for ensuring public health, is updated every other year based on recommendations from WHO's Expert Committee on the Selection and Use of Essential Medicines. "These medicin...
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    EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25

    The European Medicines Agency (EMA) on Wednesday announced that it has accepted five additional therapies to its PRIME (PRIority MEdicines) scheme, bringing the total number of products accepted to the program to 25. The agency also said it denied seven requests for eligibility, which seeks to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors. While this latest batch of recomme...
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    Challenges Providing Pharmaceutical Products to Syrian Refugees

    This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality. Introduction Providing healthcare aid to civilians during war and crisis is a complicated task. The Syrian war has impacted the healthcare system inside Syria and the neighboring countries. Large and small humanitarian organizations have wor...
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    UK Patients to Get Early Access to AbbVie's HCV Combo

    Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday. The combination, known as glecaprevir/pibrentasvir, is currently undergoing an expedited review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for its potential to treat patients across all six major genotypes of HCV, with or wi...
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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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    European Regulatory Roundup: EU Trade Groups Propose Criteria for Deciding EMA’s New Home (2 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. European Trade Groups Propose Criteria for Deciding New Home of EMA European biopharma trade groups have jointly set out criteria for deciding on the new home of the European Medicines Agency (EMA). The three trade groups detailed their desire for the selection process to consider six essential criteria in a letter to a high-ranking health official at the European Commission...
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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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    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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    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,...
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    BMS' Opdivo Wins UK EAMS Approval for Hodgkin's Lymphoma

    The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday accepted Bristol-Myers Squibb's Opdivo (nivolumab) to its early access to medicines scheme (EAMS) to treat relapsed or refractory Hodgkin's lymphoma. Previously, MHRA granted access to Opdivo under EAMS for patients with certain types of lung cancer, kidney cancer and melanoma. Background In March 2014, MHRA announced it was launching EAMS, saying it would allow earlier access to potentially...