• Feature ArticlesFeature Articles

    EU regulation of herbal products, Part 2: Quality, safety and efficacy, and postmarket surveillance

    The article compares and contrasts the regulatory requirements for herbal medicinal products (HMPs), herbal-based medical devices and botanical food supplements in the EU. It is part 2 of a two-part article – Part 1 presented the definitions, main regulations, and documentation requirements for placing the products on the market; Part 2 will address quality, the strength of evidence supporting the safety and efficacy, and postmarket surveillance (PMS) requirements across...
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    October’s Regulatory Focus: Linguistic review, advanced therapies in Asia-Pacific, and more

    Feature articles during October included an in-depth look at the linguistic review process in Europe and  reviews of the regulatory pathways for herbal medicinal products, medical devices, and supplements in the EU and for advanced therapies in the Asian-Pacific region. Also included was an article on the challenges of data integrity remediation in cGMP facilities.   Linguistic review and herbal product regulation The linguistic review process for centrally authori...
  • Feature ArticlesFeature Articles

    EU regulation of herbal products, Part 1: Definitions, regulations, and documentation

    This article compares and contrasts the regulatory requirements for herbal medicinal products, herbal-based medical devices, and botanical food supplements in the EU. It provides an overview of the current framework, highlights areas of controversy, and presents recent regulatory developments. The article is the first of two on this topic. The current article presents the definitions, main regulations, and documentation requirements for placing the products on the market;...
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    Regulation of advanced therapy medicinal products in the EU

    This article explains some of the terminology relating to advanced therapy medicinal products (ATMPs), including gene and cell-based therapies, tissue-engineered products, and combined ATMPs. The author explains the key EU regulations and guidance documents for each therapy type and discusses marketing authorization, accelerated regulatory pathways, and market access. He advises companies navigating this complex regulatory environment to engage with the regulatory agencies...
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    Identification of Medicinal Products (IDMP) Standards Part 4: Technical Approaches to IDMP

    This article discusses IT approaches to support a gap analysis and implementation of the upcoming Identification of Medicinal Products (IDMP) standards with regard to generating, collecting and mapping accurate and correct data prior to submission in an effort to prevent delays in a product reaching the market. This is the final installment in a four-part series on the IDMP standards and their respective implementation guidelines. 1-10 The first three articles explained...
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    Identification of Medicinal Products (IDMP) Standards Part 2: The Implementation Roadmap

    This is part two of a series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. 1-9 Part two reports on current IDMP activities and provides the plans and timelines in the IDMP implementation process. Part one 10 presented the reasons for the new standard, the driving forces behind IDMP and the concepts behind the standard. Current Status of ISO Activities A new version of the International Organization for...
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    Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World

    This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. 1-9 This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry. Why IDMP? Despite clear progress in the development of increasingly specific and complex drugs, health authorities worldwide say they have observed a steady and alarming increase in ...
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    Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (29 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Starts Review of Drug Recall Guidelines The Drugs Consultative Committee (DCC) of India has committed to reviewing the guidelines on drug recalls to ensure substandard products are effectively removed from the market. Officials want to make manufacturers monitor the quality of drugs in the supply chain and hold them responsible for voluntarily recalling products that ...
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    Following Injuries and Deaths, FDA Amends Regulations on CGMP and Labeling of Medical Gases

    The US Food and Drug Administration (FDA) on Thursday amended its current good manufacturing practice (CGMP) and labeling regulations for medical gases. The changes come as the agency cites “a number of incidents” where medical gas containers holding gases other than oxygen were erroneously connected to a health facility’s oxygen supply system, leading to serious injuries and deaths. “The final rule is intended to increase the likelihood that the contents of medical g...
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    Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds

    For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments. “The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report says. “In countr...
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    ISO IDMP: Another Compliance Project or a new way of Conducting Business?

    This article discusses Identification of Medicinal Products (IDMP) as a new way of conducting business, the benefits gained by adopting the IDMP model and how IDMP can be implemented to help businesses run more efficiently. To support the continuous improvement of pharmacovigilance oversight within the EU, the European Commission (2012) has mandated pharmaceutical companies to submit product information according to ISO IDMP standards. 1 The standards are global and o...
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    FDA Revises Draft Guidance on Certification Process for Medical Gases

    The revisions on the 2012 draft guidance on the certification process for medical gases includes new discussions on the labeling for final use containers and what documentation is necessary for marketers of a medical gas that are not the original manufacturer or marketer. The revisions are in response to comments made on the initial guidance on certifying medical gases, though FDA says it doesn’t believe the changes will have too much of an impact on industry. Labe...