Featured Articles

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

The Expanding Role of Regulatory Operations: How Technology Advances Have Equipped Operations Teams to Play a New Strategic Role

This article discusses the expanding function regulatory operations plays within organizations and how their broader responsibilities as process engineers, RIM systems experts and business analysts will play an increasing role in the organization's success.

Categories: Business Skills, Submission and registration, Features Tags: Regulatory Information Management, RIM, Regulatory Operations
Transformation Underway in how Regulatory Information is Globally Managed

This article discusses a new World Class Regulatory Information Management (WCRIM) standard and current industry status.

Categories: Features Tags: Regulatory information management
eCTD: Journey Through the Decade

This article discusses transitioning and implementing the electronic Common Technical Document (eCTD) in different regions a decade after its conceptualization. The article further discusses its impact on dossier compilation and document design practices as well as challenges faced by the pharmaceutical industry for effective lifecycle management.

Categories: Submission and registration, News, US, Canada, Europe, Japan Tags: Electronic Common Technical Document, eCTD
The Path to Successful Global Regulatory Operations: Document Management Processes and Technology Challenges

This article discusses the process and technology challenges regulatory operation organizations face as they seek to operate globally and provides recommendations for how they can begin addressing them.

Categories: Drugs, Business Skills, Project management, Features Tags: Document Management, Process Mapping, Cloud
Can Health Technology Assessment be Used to Demonstrate Significant Benefit for an Orphan Medicinal Product in the EU?

This article discusses how the conceptual grounds for significant benefit are addressed in the context of the orphan medicinal product regulations in the EU and how techniques used in Health Technology Assessment (HTA) may support the justification for the claim of significant benefit.

Categories: Biologics and biotechnology, Drugs, Orphan products, Reimbursement, Features, Europe, EMA, EC Tags:
Accelerating Global Submissions with a Six-Point eCTD Strategy

This article discusses how an integrated, six-point electronic Common Technical Document (eCTD) publishing strategy can accelerate global submissions and enhance the efficiency of regulatory operations. In addition, it outlines challenges specific to: large companies with a well-established, eCTD-compliant publishing capacity, but may lack strategic agility; and smaller companies with limited eCTD resources and expertise.

Categories: Drugs, Regulatory strategy, Submission and registration, Features, US, Canada, Europe, Japan, FDA Tags: eCTD, Electronic Submissions, Common Technical Document
Rigorous Amendments Proposed to the Marihuana for Medical Purposes Regulations

This article discusses professional colleges complying with new amendments to Marihuana for Medical Purposes Regulations.

Categories: Government affairs, Features, Canada, Health Canada Tags:
What's Happening Down Under? The Australian Regulatory Scene in 2016

This article discusses the current regulatory framework for drugs and medical devices in Australia, compares differences in regulatory processes between Australia, the US and the EU and predicts future developments and challenges for industry and regulators.

Categories: Biologics and biotechnology, Cosmetics, Prescription drugs, Over the counter drugs, Human cell and tissue, In vitro diagnostics, Medical Devices, Veterinary products, Features, Oceania, TGA Tags:
Entering the China Market: Best Practices - Part 1

This article explores some of the considerations and best practices for foreign firms prior to entering the Chinese medical device market, specifically prior to and during the registration process.

Categories: Medical Devices, Clinical, Postmarket surveillance, Submission and registration, Features, China, CFDA Tags:
China's Drug Regulation Revolution: An interview With Dr. Ling Su

In this article, Regulatory Focus interviews Dr. Ling Su, a member of RAPS' China Advisory Committee. Dr. Su has worked at both the Chinese regulatory agency (CFDA) and the US Food and Drug Administration (FDA), and served in R&D managerial positions at a number of large, multinational pharmaceutical companies. He was also the first person from Asia elected to serve as the president of Drug Information Association (DIA).

Categories: Drugs, Submission and registration, Features, China, CFDA Tags:
The New KYSS Principle: Know Your Supplier's Supplier

This article introduces the KYSS principle to align a robust supplier management program with regulatory requirements and includes initial identification and qualification of suppliers, supplier quality agreements and both initial and ongoing supplier monitoring.

Categories: Drugs, Medical Devices, Quality, Features, FDA, EMA, ICH Tags: Supplier verification, Supplier qualification, Monitoring, Know your supplier's supplier, KYSS
What Is 'Regulatory Intelligence?'

This article provides an overview of regulatory intelligence, including identifying sources, using tools for gathering information, and the importance of recognizing copyright restrictions.

Categories: Regulatory strategy, Regulatory intelligence, Features Tags: Regulatory Intelligence, Twitter, RSS
Say What? Health Canada is Cracking the Whip on Advertising Violations

Advertising violations published by Health Canada in January may be sign of new transparency initiatives.

Categories: Drugs, Features, Canada, Health Canada, Advertising and Promotion Tags:
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.

Categories: Drugs, Features, FDA, EMA, WHO Tags: Counterfeit medicines
Preparing the Common Technical Document (CTD) Module 3 for Radiopharmaceuticals

This article discusses the nuances of Module 3 composition for the registration of radiopharmaceuticals.

Categories: Drugs, Regulatory strategy, Submission and registration, Features, FDA Tags:
Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps

This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers who would like to enter this geographical market. In addition, solutions to maximize the product development strategy are discussed with the intention of bridging regulatory and market access gaps.

Categories: Biologics and biotechnology, Drugs, Reimbursement, Regulatory strategy, Features, Europe, EMA, EC Tags: Health technology assessment, HTA, Reimbursement, Market access, EUnetHTA, Target product profile
Using Social Media to Promote FDA-Regulated Products - A Balanced Approach is Best

This article shares some of the current thinking on best practice uses of social media in promoting FDA-regulated products.

Categories: Drugs, Features, FDA, Advertising and Promotion, Communication Tags: Social media
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.

Categories: Drugs, Labeling, Packaging, Features, Europe, EMA, EC Tags: IDMP, ISO, Identification of Medicinal Products, Regulatory Information Management
Ethics and Risk Management: Lessons from the VW Defeat Device

This article discusses risk management practices from the automotive industry and what the biomedical industry can learn from recent current events.

Categories: Crisis management, Compliance, Due Diligence, Regulatory strategy, Regulatory intelligence, Features Tags: Risk management, Volkswagen, Defeat device,
Meeting With EU Regulatory Agencies: Part II

This article discusses the main types of European regulatory agency interactions an applicant may have during the development of a medicinal product in the EU, on the path to registration. It provides the rationale to request meetings with European authorities and presents the procedures and protocols involved with these interactions.

Categories: Regulatory strategy, Features, Europe, EMA, MHRA, Communication Tags:
Meeting With EU Regulatory Agencies: Part I

This article discusses the main types of European regulatory agency meetings and interactions an applicant may have during the development of a medicinal product on the path to registration in the EU. It provides some insight on the rationale to request meetings with European authorities and procedures and protocols involved with these meetings.

Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, Europe, EMA, MHRA, Communication Tags:
Race to Comply with FDA ESG Guidelines

For life sciences companies, paper-based commercial material submissions do not cut it anymore, not only when it comes to automating processes for improved efficiency, but also in the face of rapidly approaching new regulatory guidelines on electronic submissions from FDA. This article discusses the urgency as well as the findings of a 2015 global commercial content management study.

Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, US, FDA Tags: Electronic submissions gateway, ESG
Worksharing in the Evaluation of Active Substances

This article describes ongoing procedures and initiatives for 'worksharing' in the evaluation of active substance dossiers by regulatory authorities around the world.

Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, US, Canada, Europe, Asia, FDA, EMA, Health Canada, MHLW, PMDA Tags: Active Substance, Drug Master File, ASMF, DMF, Worksharing
Precision Medicine: Technology, Regulations and Challenges

This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare.

Categories: Biologics and biotechnology, In vitro diagnostics, Reimbursement, Regulatory strategy, Features, FDA Tags: Precision medicine, Precision medicine initiative, PMI, Next generation sequencing
World Drug Firsts from Asia (Outside Japan)

This article discusses some notable drug firsts from Asia (outside Japan) and reaffirms the innovation potential in this region, beginning with a reference to the discovery of artemisinin, a valuable drug and key ingredient in the fight against malaria, and concluding with a reference to a new paradigm: a shift of the "center of gravity" of innovation from the West toward the East.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, China, Taiwan, Korea, India, Asean, CFDA, MFDS, CDSCO Tags:
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