Featured Articles

In-depth examination and analysis of regulatory and related topics, available exclusively to RAPS members.

Is the Current Regulation of Autologous Stem Cells Appropriate?

This article discusses the regulation of autologous stem cells and tissue therapies in Australia by addressing issues such as the safety and efficacy of cell therapies, which therapies are regulated, what regulators are doing in other countries and "next steps" in cell and tissue regulation.

Categories: Human cell and tissue, Features, US, Europe, Japan, Oceania, FDA, EMA, MHLW, PMDA, TGA Tags: Autologous Stem Cells
Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan

This article focuses on key regulatory activities to establish a Joint Venture (JV) for pharmaceutical manufacturing and sales in Japan. The author describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities.

Categories: Biologics and biotechnology, Drugs, Clinical, Postmarket surveillance, Submission and registration, Features, Japan, MHLW, PMDA Tags: Common Technical Document, CTD
Fast Facts: Serious Adverse Event Reporting Requirements in the US

This article presents reporting requirements for Serious Adverse Events (SAEs) and focuses on an important, but often overlooked regulation that specifies when a study is being run and includes the use of an approved drug. There are reporting requirements with specific timeframes that must be followed if there is a reportable SAE attributed to the approved drug.

Categories: Biologics and biotechnology, Drugs, Clinical, Postmarket surveillance, Features, US, FDA Tags: Adverse Event Reporting
When to Submit a 510(k) (Devices and Software): A Regulatory Perspective

This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking.

Categories: Medical Devices, Submission and registration, Features, US, FDA Tags: 510(k), Software
The Relationship Between Regulatory and Commercial Organizations: How to Work With Your Commercial Colleagues

This article discusses why regulatory and business functions need to work together to ensure success in label development, launch, promotion and lifecycle management strategy and regulatory intelligence and provides successful partnership examples.

Categories: Business Skills, Features, Communication Tags:
Strategies and Tactics to Successfully Outsource Regulatory Work

This article highlights key learnings, helpful approaches and recommendations on how to successfully outsource operation-based regulatory work. The author Includes tips on knowing the right work to be outsourced, setting expectations, selecting a supplier, overcoming internal resistance to outsourcing, contracting standards and invoicing.

Categories: Business Skills, Features, US Tags: Outsourcing, Performance Metrics
2017 Regulatory Intelligence Tools Update: Drugs

When tasked with something new or different in regulatory, sometimes the hardest challenge is knowing where to find the information. This article provides an abundance of tools, links and places to start your journey of regulatory information discovery.

Categories: Biologics and biotechnology, Drugs, Regulatory intelligence, Features Tags:
Global Regulatory Developments in Cell and Gene Therapy, Drug Manufacturing Inspections, Regulatory Intelligence Tools and a Preview of March

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in March.

Categories: Biologics and biotechnology, Human cell and tissue, Regulatory strategy, Regulatory intelligence, Features, FDA, EMA, Health Canada, CFDA, ISO Tags: Regulatory Focus, Feature Articles, Feature Summary
MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU

This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, Features, Europe, EC Tags: Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, MDR, IVDR
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. Part two reports on current IDMP activities and provides the plans and timelines in the IDMP implementation process. Part one presented the reasons for the new standard, the driving forces behind IDMP and the concepts behind the standard.

Categories: Biologics and biotechnology, Drugs, Features, US, Europe, FDA, EMA Tags: ISO, ISO IDMP, Identification of Medicinal Products
Advanced Therapy Medicinal Products: An Evolving Regulatory Landscape

This article was developed from a presentation at RAPS Regulatory Convergence in September 2016 in San Jose, California, US. It was the opening presentation in the "Global Developments in Cell and Gene Therapy" session and covered introductory Advanced Therapy Medicinal Product (ATMP) concepts from definitions to strategic considerations and challenges currently faced by developers in this field.

Categories: Biologics and biotechnology, Human cell and tissue, Regulatory strategy, Features, US, Europe, FDA, EMA Tags: Advanced Therapies, ATMP
Regulation and Oversight of Gene Therapy in the US

This article discusses the evolution, potential uses and regulatory aspects of gene therapy and includes funding, delivery mechanisms, bioethics and steps toward clinical trial implementation.

Categories: Biologics and biotechnology, Human cell and tissue, Features, US, FDA Tags: Gene therapy,
Alligators and Crocodiles: New Indications for Use?

This article provides current research in drug development and describes crocodilians, their immune function, the search for new antibiotics, antimicrobial peptides (also known as host defense peptides) and future research for anti-cancer agents.

Categories: Biologics and biotechnology, Research and development, Features Tags:
Regulatory Intelligence Tools Compendium 2017

This article provides a Regulatory Intelligence (RI) Tool Compendium to help readers see the tools available by each RI functional area.

Categories: Biologics and biotechnology, Drugs, Regulatory intelligence, Features Tags: Regulatory Intelligence
CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions

To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and changes; and inspection case analysis through observations by various international regulatory authorities.

Categories: Government affairs, Regulatory intelligence, Features, China, FDA, CFDA, WHO Tags: Chinese Center of Food and Drug Inspection, CFDI
CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development

This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China.

Categories: Prescription drugs, Generic drugs, Clinical, Compliance, Features, China, CFDA Tags: Draft Guidance
Where to Find Publicly Disclosed Regulatory Precedent in the EU, US and Canada

This article provides a better understanding of the types of information available from regulatory authorities by outlining sources of precedent focused on development activities, regulatory submission and evaluation, and approval and post-authorization activities.

Categories: Biologics and biotechnology, Drugs, Clinical, Labeling, Regulatory strategy, Submission and registration, Features, US, Europe, FDA, EMA Tags:
Small Organizations, Big Regulatory Strategy

This article discusses how small and young organizations, including start-ups, build powerful regulatory strategy programs that complement their research and business development efforts. Established businesses also can learn from their innovative approaches. These include navigating incentives, understanding and utilizing technology tools for regulatory intelligence like social media and crowdsourcing, and embracing a team mentality to build agile and efficient regulatory programs with a strong underlying alignment with business development.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, US, Europe, Asia, FDA, EMA Tags: Regulatory Strategy, SMEs
Regulatory Intelligence - an Integrated Tool to Strengthen Drug Development Projects and Regulatory Strategies

This article discusses the role of regulatory intelligence in drug development as well as the functional and personal competencies desired for a regulatory intelligence professional to succeed in providing value to the research and development organization.

Categories: Regulatory strategy, Regulatory intelligence, Features, FDA, EMA Tags: Regulatory Intelligence
Strategies for Smarter Compliance in a Technology-Driven FDA Environment

The article provides an overview of the significance of technology in the regulatory compliance process and offers strategies for smarter compliance.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Submission and registration, Features, US, FDA Tags: eCTD, Electronic Common Technical Document
Regulatory Intelligence - Delivering Regionally, Operating Globally

This article discusses the impact of the Internet with regard to the amount and transparency of information offered by regulatory health agencies with an emphasis on the role of regulatory intelligence in monitoring the global environment and the subsequent communication obtained from this information.

Categories: Drugs, Regulatory intelligence, Features, FDA, EMA, ICH Tags:
Aging Revisited: an Amazing Continuous Process

This article will briefly discuss the definition of aging, what it means to age, the process itself, why we age and anti-aging methods designed to increase longevity. Active research has indicated a number of medications have increased the life span in mice and other laboratory animals. Duplicating the results in human patients could make anti-aging medications the next category of truly miracle drugs.

Categories: Biologics and biotechnology, Drugs, Ethics, Features Tags:
What is a Wearable Device? Lifestyle Device vs. Medical Device

This article discusses how to determine when wearable lifestyle devices, referred to as fitness trackers, might be categorized as medical devices. In cases where fitness trackers are used in particular ways, their categorization as a medical device carries with it specific requirements for compliance to regulations. The article provides useful information to regulatory personnel in assessing how much compliance to the Health Insurance Privacy and Portability Act (HIPPA)1 is expected for a wearable lifestyle device or fitness tracker with imbedded software when used for specific purposes. The article also reviews the migration from lifestyle device to medical device and the accompanying regulatory implications, including FDA's 'intended use.' The concept of "intended use" is key in making the distinction between lifestyle device and medical device, as in the case of wearable fitness devices.2, 3

Categories: Medical Devices, Features, US, FDA Tags: Wearables, Fitness tracker, Lifestyle devices
Testing and Implementing a Web-Based, Country Regulatory Information Management System

This informal case study highlights the benefits of having structured, reliable information on country regulatory requirements by leveraging the content from a web-based platform.

Categories: Project management, Regulatory intelligence, Features Tags: Information management, Regulatory information management system
IND Application Fast Facts

This article provides information companies need when filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to help make the application process more efficient. It addresses common questions and concerns that develop across multiple companies and multidisciplinary groups.

Categories: Biologics and biotechnology, Drugs, Clinical, Preclinical, Submission and registration, Features, US, FDA Tags: IND, Investigational New Drug Application
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