• Regulatory NewsRegulatory News

    Italian Medicines Agency Uncovers Deficiencies at Two Indian Drug Plants

    The Italian Medicines Agency on Wednesday released two statements of non-compliance with regard to good manufacturing practices (GMPs) for Visakhapatnam, India-based Krebs Biochemicals & Industries and Daund, India-based JP Laboratories. At the Krebs facility, the Italian regulators uncovered 24 deficiencies, five of which were classified as major. “The combination of the findings demonstrated a critical risk to public health, as the weaknesses of the company’s qua...
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    Combating Counterfeit Medicines: Legal Frameworks and Emerging Technologies

    This article discusses the global problem of drug counterfeiting, reviews legal and manufacturing requirements imposed in the EU and US to protect against it and devices aimed at detecting counterfeit drugs. Introduction According to the EMA, counterfeit medicines are any medicinal product that does not comply with intellectual property rights and or infringes on trademark law 1 which differs slightly from the term falsified medicine which is described by the falsifi...
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    FDA Considers New User Fee Program for OTC Drugs

    The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs. User fee programs (such as PDUFA , GDUFA , BsUFA and MDUFA , all of which are now being re-negotiated for 2017) are the life blood of FDA and provide much-needed financial resources from industry, in addition to Congressional appropriations, that support the timely and efficient review of...
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    Article 58: How EMA Helps Increase Access to Drugs in Low- and Middle-Income Countries

    Ten years into the European Medicines Agency’s (EMA) regulatory experiment to try to increase access to medicines in low- and middle-income countries (LMICs) and the agency is seeing limited success, though enhancements outlined in a new report could increase the utility of the program. Background Article 58 of Regulation (EC) No 726/2004, introduced first in 2004, allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with ...
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    EMA Drafts Framework for Extrapolating Adult Patient Data for Pediatric Indications

    The European Medicines Agency (EMA) released a reflection paper on Monday with the hope of helping drugmakers avoid unnecessary pediatric research by establishing a framework for extrapolating clinical data from adult patients to support pediatric indications for new drugs. EMA says the framework will help "optimize" clinical trial participation for pediatric patients by using existing data from other populations, including adults and other pediatric subgroups, to predic...
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    Transparency: What FDA Drug, Device Regulations are Coming Later in 2016

    As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules. By 31 March, according to the TRACK database, the agency expects to release four final rules and three propose...
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    MSF: Access to New TB Medicines Falters Despite Conditional Approvals

    Doctors without Borders (MSF) released a new report on Monday offering details on how the first new drugs in nearly half a century were conditionally approved to treat tuberculosis (TB),  though only 2% of the roughly 150,000 who could benefit from these treatments have access to them. The report comes as the World Health Organization (WHO) reports that only half of notified multi-drug-resistant tuberculosis (MDR-TB) patients were successfully treated and cured in 2014 ...
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    EMA Looks to Accelerate New Therapies Targeting Unmet Needs

    The European Medicines Agency (EMA) on Monday launched its new PRIME (PRIority MEdicines) scheme which aims to streamline the development of promising new therapies that meet unmet medical needs. Like the breakthrough therapy program in the US, the new EMA program aims to accelerate the development of new drugs to treat rare cancers, Alzheimer's and other neurodegenerative diseases, AIDS and diabetes, among others. "I think we still see too many patients in desperate n...
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    EU Regulation Requires New Safety Features on Drug Packaging by 2019

    A new regulation will require prescription drugmakers in all but three EU countries to incorporate new safety features on their product packaging by 9 February 2019. The European Medicines Agency (EMA) says these measures will protect patients from falsified and low-quality medicines by guaranteeing authenticity and improving supply chain security. The requirements are described in Commission Delegated Regulation (EU) 2016/161 , published in the Official Journal of ...
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    Orphan Medicines in the EU: A 15-Year Review

    With the 15th anniversary of the adoption of the Orphan Regulation in the EU, the European Commission notes in a new report that this landmark regulation has incentivized the development, approval and marketing of more than 100 rare disease treatments, or orphan drugs. According to the European Commission’s fourth inventory of orphan medicines, released Friday, somewhere between 5,000 and 8,000 different rare diseases exist in the EU, impacting between 27 million and 36 ...
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    European Regulatory Roundup: EMA Updates HRT Warning on Ovarian Cancer Risk (14 January 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Updates HRT Product Information to Clarify Ovarian Cancer Risk EMA has updated the product information for hormone-replacement therapy (HRT). The changes follow a review by the Pharmacovigilance Risk Assessment Committee (PRAC) late last year, which concluded EMA should strengthen the warning about the link between HRT and ovarian cancer. In the previous product informa...
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    Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery

    The following chapter is an excerpt taken from  Fundamentals of EU Regulatory Affairs, Seventh Edition . Objectives Introduce the problem of falsified medicines Define falsified and counterfeit medicines Define active substances and excipients Explain the aims and scope of the Falsified Medicines Directive ( FMD ) Directive 2011/62/EU ) Identify requirements for different stakeholders in the medicines supply chain arising from the FMD ...