• Feature ArticlesFeature Articles

    Drug preclusion and public health: The case for a narrow interpretation of ‘article’

    The definition of “dietary supplement” in the Food, Drug, and Cosmetic (FD&C) Act includes several provisions limiting what can be a legal dietary supplement based on the ingredients used and delivery form, as well as whether a substance has a history of drug use. This article explores the US Food and Drug Administration’s (FDA’s) use of this last provision, often called “drug preclusion.” The authors examine the history of the provision, Congress’s purported purpose for ...
  • Regulatory NewsRegulatory News

    EMA finalizes guidance on parallel MAA, EU-M4all procedure

    The European Medicines Agency (EMA) on Thursday released the final version of its guidance detailing the agency’s procedure for parallel EU-M4all (Article 58) and centralized marketing authorization applications (MAAs).   The guidance was adopted earlier this month following a public consultation launched in January and includes some minor changes from the draft version. (RELATED: EMA offers parallel Article 58, centralized authorization reviews , Regulatory Focus ...
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    EMA offers parallel Article 58, centralized authorization reviews

    The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion and centralized marketing authorization for medicines they intend to market in the EU and abroad.   The Article 58 procedure allows EMA’s Committee for Medicinal Products for Human Use (CHMP) to give opinions in cooperation with the World Health Organization (WHO) on medicines intended to be used in low- an...
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    EMA Explains How it Supports Article 58 Applications

    The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs). Background First introduced in Regulation (EC) No. 726/2004 in 2004, the Article 58 procedure allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in collaboration ...
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    EMA Updates Q&A on Article 31 Referrals

    The European Medicines Agency (EMA) on Tuesday issued a new version of its questions and answers (Q&A) guide on Article 31 non-pharmacovigilance referrals. Background In the EU, an Article 31 referral is a procedure in which member states or the European Commission may request that EMA conduct a scientific review of a medicine for quality, safety or efficacy reasons. Unlike Article 20 referrals, Article 31 referrals may apply to any medicine or class of medicine autho...
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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 to Review InductOs After US Manufacturer Cited for Contamination Issues

    The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs, after Spanish and Dutch inspectors discovered contamination issues at a US manufacturing site which makes one of its components. Background InductOs was authorized via the centralized procedure in 2002 and is marketed by Medtronic BioPharma B.V., headquartered in the Netherlands. InductOs is used to promote bone development in pati...
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    Why EMA Recommends Medicines for Foreign Use: Article 58 Procedure

    Today, the European Medicines Agency (EMA) recommended the world's first malaria vaccine. However, unlike most of the medicines EMA reviews, the agency's recommendation won't be forwarded to the European Commission for authorization. In fact, EMA's recommendation only applies to regions outside the EU. Instead, the World Health Organization (WHO) and other non-EU regulators will review EMA's recommendation and make a determination on the vaccine's use. Mosquirix The va...
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    EMA to Share Information About Generic Drugs With Other Regulators

    The European Medicines Agency (EMA) has announced it is ready to begin sharing its assessments of generic drugs as part of an ongoing pilot with participating regulatory authorities. The goal of the pilot program, known as the International Generic Drug Regulators Pilot (IGDRP), is to bolster collaboration with regulators around the world and address the challenge of assessing generic drug applications. Background In October 2011, regulatory authorities from Australia...
  • EMA Revamping How it Handles Submission of Applications and Requests for Advice

    The European Medicines Agency (EMA) has announced that it will soon change the way it handles changes to approved marketing authorizations (MAs) and other regular reports. Background As in the US, pharmaceutical companies are required to notify EMA of all changes made to their medications and manufacturing processes, as well as keep regulators informed about the safety of their products and any transfers of ownership. Those changes fall into several categories , inclu...
  • EMA to Phase out Support for Non-Electronic Submissions in 2014

    The European Medicines Agency (EMA) has announced that its eSubmission Gateway will become mandatory for all electronic common technical document (eCTD) submissions made to the agency through the centralised procedure starting in May 2014. Background The eCTD is a standardized document format used around the world for the submission of pharmaceutical products, and uses a module approach to organize data in a way that makes submissions acceptable to a wide range of reg...
  • EMA to Conduct Safety Review of EU and Nationally Approved Drugs

    The European Medicines Agency (EMA) has announced a milestone safety review of drugs approved through both the centralized EU procedure and the national procedure, based on the active substance that a drug contains. The review is slated to begin on 1 April 2013. Until now, the agency's review of the safety of marketed drugs has been limited to medicines authorized through the centralized procedure.  EMA's expanded authority to undertake such a review was granted ...