Featured Articles

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

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:
Strategic Regulatory Considerations for Early Medical Device Consultations with Global Regulatory Authorities

This article discusses the early consultation process for medical devices in the EU and US and key considerations when planning such a meeting.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Business Skills, Regulatory strategy, Submission and registration, Features, US, Europe, FDA, EMA, Communication Tags: Pre-submission meetings, Competent authority, Notified body
Early Biosimilar Development: A Model for Expeditious Progress to a Phase 3 Trial

This article discusses biosimilar clinical development and how companies are addressing the clinical development concerns associated with early biosimilar drug development.

Categories: Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy, Features, US, Europe, FDA, EMA, EC Tags: Biosimilars, Clinical development, CMC
Drug Development in Asia: Scattering the Mist

This article discusses misconceptions and their causes, surrounding drug development in Asia, and explains the regions current drug development landscape.

Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, Features, Japan, China, Korea, Asean, MHLW, PMDA, CFDA, MFDS, ICH, APEC Tags: Data exclusivity, tripartite cooperation on clinical research, Tripartite Working Group, TRIPS, ICH-E5, APEC, ASEAN, Biosimilars
Integrating FDA Meetings into a Medical Device Regulatory Strategy

An often overlooked opportunity for a successful device regulatory strategy is the optimal use of a pre-submission meeting with the regulatory agency. Meeting with the US Food and Drug Administration (FDA) to request feedback on specific submission issues has been formalized into what is collectively called the Q-Submission (Q-Sub) Program. A detailed description of the different types of FDA meetings is provided in FDA's Guidance document on Q-Subs.

Categories: Medical Devices, Regulatory strategy, Submission and registration, Features, US, FDA, Communication Tags: Q-Submission, Q-Sub, Feedback, Novel Technology Regulation
Medicines360 Makes Nonprofit Pharma Possible with Cloud Technology

This article outlines a unique nonprofit pharmaceutical company's path to increased quality and compliance using new cloud-based regulated content management technology. Medicines360 needed a best-in-class solution to efficiently manage and track an increasing number of critical SOPs to help ensure product quality and regulatory compliance as it launched its first commercial drug and prepared for inspections.

Categories: Business Skills, Compliance, Submission and registration, Features, US, FDA Tags: Liletta, Medicines360
Fundamentals and Global Impact of 510(k) for Medical Devices

This article presents an overview of the fundamentals of 510(k) submissions, including the impact of the unique regulations to US and foreign device manufacturers.

Categories: Medical Devices, Submission and registration, Features, US, CDRH Tags: 510(k), Preamendment devices, Third party review, Abbreviated 510(k), Special 510(k)
FDA's New Office of Pharmaceutical Quality

The Center for Drug Evaluation and Research Office of Pharmaceutical Quality (OPQ) was launched in 2015. This article examines FDA's reasons for implementing a major change to oversight of manufacturing quality and the implications for consumers, sponsors and regulatory professionals.

Categories: Drugs, Manufacturing, Quality, Features, US, FDA Tags: Office of Pharmaceutical Quality, OPQ, Quality Metrics,
Practical Guidance for Regulatory Professionals on Combination Products

This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities.

Categories: Combination products, Research and development, Submission and registration, Features, US, Europe, FDA, EMA, EC, ICH, IMDRF Tags: Combination products, Design validation, Risk management, IMDRF
510(k) Submissions: Current Trends and Tips

This article discusses current trends in the 510(k) submission process, primarily with Class II orthopedic and spinal implants, and will provide tips on maintaining a smooth and successful submission process.

Categories: Medical Devices, Regulatory strategy, Submission and registration, Features, US, CDRH Tags: 510(k), Sterilization validation, deficiencies, guidance
The 'Catch-Up' 510(k) - A Submission Often Overlooked

This article discusses "catch-up" 510(k) submissions, circumstances under which a "catch-up" 510(k) submission should be considered, content and timing of such a submission and procedural recommendations for this submission type.

Categories: Medical Devices, Submission and registration, Features, US, CDRH Tags: 510(k), catch-up 510(k),
FDA Regulation and Personalized Medicine

This article discusses examples of personalized medicine in industry as well as examples of FDA regulatory activities with respect to personalized medicine.

Categories: Biologics and biotechnology, Clinical, Labeling, Postmarket surveillance, Research and development, Regulatory strategy, Submission and registration, Features, US, FDA Tags: Personalized Medicine
Registration Procedures for Medicinal Products in China

This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs.

Categories: Drugs, Compliance, Government affairs, Submission and registration, Features, China, CFDA Tags: Center for Drug Evaluation, Chinese Pharmacopoeia Commission, National Institutes for Food and Drug Control, Center for Certification of Drugs, Center for Drug Re-Evaluation, CDE, CPC, NIFDC, CCD, CDR, Marketing Authorization,
Pharmaceutical Marketing via Social Media

This article discusses the ongoing effort by the pharmaceutical industry to use social media as a marketing tool. It presents benefits and limitations of using this form of media and describes recent progress in public communication.

Categories: Drugs, Features, US, FDA, Advertising and Promotion, Communication Tags: Social Media, IMS Health Social Media Engagement Index
Draft National Medical Device Policy—2015: A Review and Analysis

This article reviews the Draft National Medical Device Policy (NMDP-2015) proposed by the government of India and evaluates potential pros and cons of its most important feature.

Categories: Medical Devices, Government affairs, Manufacturing, Research and development, Features, India Tags: Draft National Medical Device Policy, NMDP-2015, Make in India
Creating Type IA and Type IB Variation Submissions in Europe

This article discusses the creation of minor variations within the European Union.

Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, Europe, EMA Tags: Type IA Variations, Type IB Variations
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