The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that are counterfeit, diverted, stolen, fraudulent or unfit for distribution.   The guideline aims to help industry meet their verification obligations under the Drug Supply Chain Security Act (DSCSA) which requires trading partners to be able to identify a suspect or illegitimate product. The guidance ...

Artificial intelligence as medical devices (AIaMDs) have the power to learn from real-world performance and over time and may provide a different output compared with that initially cleared for a given set of inputs. However, regulatory frameworks have remained relatively unchanged and are largely focused on approaches around traditional hardware-based medical devices. In this article, the authors explain the US Food and Drug Administration’s (FDA’s) current thinking on en...

In the EU and European Economic Area (EEA), certain products receive marketing authorization through the centralized procedure (CP). Following this, a number of documents, such as the product information (PI), require translation into all 24 EU and EEA official languages. The translations provided by the marketing authorisation holder (MAH) are approved by the corresponding EU member states. This review and approval process of the 24 languages is known as the linguistic re...

This article describes the main changes of China's drug and device regulatory system in the past 70 years, with the focus on medical devices rather than drugs. The article highlights the latest changes in the regulation of medical devices and examines international cooperation in the field of medica devices and the regulatory framework for the medical device product life-cycle in China. It also includes the latest updates for medical device regulation in 2022 and beyond. ...

The Healthcare Distribution Alliance (HDA) on Monday issued a guide to help the pharmaceutical industry in formatting and placing bar code labels on their products to comply with Drug Supply Chain Security Act (DSCSA) requirements for tracking products through the supply chain.   DSCSA was signed into law in November 2013 and outlines the necessary steps necessary to build and electronic, interoperable system to identify and trace prescription drugs distributed in ...

European regulators on Tuesday announced the adoption of a common electronic product information (ePI) standard for human medicines that can be accessed by users and healthcare providers alike.   ePI is beneficial because it can be updated and disseminated to stakeholders immediately, without having to wait for new information to be formatted and printed, European Medicines Agency officials said in a statement . EMA released the standard along with the European Commis...

While the primary goal of the clinical development team is to obtain product approval, companies must have a broader vision that supports the complete product lifecycle. Experts in regulatory advertising and promotion (A&P) have a detailed knowledge of the US Food and Drug Administration (FDA) requirements for product promotion. Beyond supporting the promotional review process, the unique skill set of regulatory A&P should be applied to other critical activities, including...

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...

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...

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;...

Feature articles during May focused on the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR). The 26 May deadline for the MDR has come and gone, and the regulation is now being fully applied after a yearlong delay because of the pandemic. Next up is the application deadline for the IVDR, now set for 26 May 2022. Articles in this issue examined the extent of preparedness among regulators, sponsors, and manufacturers for the two application ...

The US Food and Drug Administration (FDA) on Wednesday issued 13 new and eight revised draft product-specific guidances intended to facilitate the development of generic drugs.   The guidances are intended to foster generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug (RLD). FDA’s current count of product-specific guidances sits at 1,896 with this latest release....