Featured Articles

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

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.

Categories: Biologics and biotechnology, Drugs, Features, US, Europe, FDA, EMA, ISO Tags: Identification of Medicinal Products, IDMP
Regulating Pediatric Studies: An EU and US Perspective

This article presents pediatric regulatory activities conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and highlights global harmonization efforts, collaborative discussions and regulations for pediatric clinical trials.

Categories: Biologics and biotechnology, Drugs, Clinical, Features, US, Europe, FDA, EMA Tags:
Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions

This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan.

Categories: Drugs, Submission and registration, Features, US, Canada, Europe, Japan, Oceania, FDA, EMA, Health Canada, PMDA, TGA Tags: Quality Certificates, eCTD, GMP
Conditional Approvals for Early Access to New Medications

This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, US, Europe, Japan, FDA, EMA, PMDA, ICH Tags: Conditional approval, Regenerative medicine
Navigating the Medical Device User Fee Act (MDUFA)

This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.

Categories: Medical Devices, Submission and registration, Features, US, CDRH Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees
ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.

Categories: Biologics and biotechnology, Drugs, Quality, Features, US, Europe, FDA, ICH Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD
Generic Drug User Fee Act (GDUFA): Overview and Proposed Changes for 2018

This article discusses aspects of the Generic Drug User Fee Act enacted by Congress as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), including fees, changes enabling FDA to speed up reviews, GDUFA goals and proposed changes and impacts as the first five–year phase concludes in 2017.

Categories: Generic drugs, Submission and registration, Features, US, FDA Tags: GDUFA
Regulatory Harmonization Initiatives

This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Compliance, Features, US, Canada, Europe, Asia, Latin America and Caribbean, Africa, Middle East, Oceania, ICH, IMDRF, GHTF, APEC, OECD, WHO, ISO Tags: Harmonization
FDA User Fee Programs

This article provides an overview of upcoming important changes to FDA's major user fee programs (PDUFA VI, MDUFA IV and GDUFA II) for Fiscal 2018–2022. It discusses new performance goals, additional commitments FDA has agreed upon with industry and how these changes could impact various types of industry submission strategies.

Categories: Biologics and biotechnology, Generic drugs, Medical Devices, Submission and registration, News, US, FDA Tags: User Fees, PDUFA, MDUFA, GDUFA
Thailand's Approach to Drug Quality Assurance: Creation of the Green Book

This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines.

Categories: Drugs, Quality, Features, Asia Tags: Thailand, Green Book, Quality Assurance
Identification of Medicinal Products (IDMP) Standards Part 3: Steps to Prepare for IDMP Implementation

This article discusses the gap analysis and preliminary activities necessary to prepare a pharmaceutical company for the upcoming IDMP standards; it is the final article in a three part series on the standards and their respective implementation guidelines. The first two articles presented reasons for the new standard, the driving forces behind IDMP, and the concepts behind the standard as well as the current timelines for introducing IDMP in worldwide markets.

Categories: Drugs, Features, FDA, EMA, ISO Tags:
The Prescription Drug User Fee Act (PDUFA): A Primer

This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process.

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, FDA Tags: User Fees, Prescription Drug User Fee Act, PDUFA
Impact of the Revised EU Clinical Trial Regulation

Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulation are still underway, readers will benefit from the assessment of its current status and anticipated developments.

Categories: Biologics and biotechnology, Drugs, Clinical, Features, Europe, EMA, EC Tags: Clinical Trial Regulation, EU No 536/2014
Amendments to the 21st Century Cures Act: Changing the Regulation of Combination Products

This article summarizes regulatory changes impacting how premarket applications for combination products will be reviewed by FDA and procedures and reporting requirements for applicants and FDA as required by the 21st Century Cures Act.

Categories: Biologics and biotechnology, Combination products, Drugs, Medical Devices, Features, US, FDA Tags: 21st Century Cures Act, Combination Products, Primary Mode of Action, PMOA
Strategies Adopted by Innovator Companies in Response to Biosimilars Competition

This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars.

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration, Features, US, Europe, FDA, EMA Tags: Biosimilars, Intellectual Property, Litigation, Patent Extension
Biosimilar Intellectual Property Issues in the US: An Update

This article provides an update on US biosimilar intellectual property issues in areas including the complex and evolving areas of patent protection, market exclusivity, the 'patent dance,' and lifecycle planning.

Categories: Biologics and biotechnology, Submission and registration, Features, US, FDA Tags:
EU and US Regulations for Chemical Components in Medical Devices

This article discusses a number of regulations directed at the use of chemical components in medical devices, both in the EU and US. The author reviews legislation, offers compliance advice and warns about the penalties of noncompliance.

Categories: Medical Devices, Compliance, Features, US, Europe, FDA, EC Tags: Chemical Components, Restricted Substances
Drug Regulatory Authority of Pakistan: Organizational Structure, Functions and Future Challenges

This article discusses the development of a more effective pharmaceutical regulatory environment in Pakistan through the establishment of a regulatory agency designed to address current good manufacturing practices and quality management systems for drug production to improve the availability, accessibility and affordability of drugs.

Categories: Drugs, Compliance, Quality, Submission and registration, Features Tags: DRAP, Drug Regulatory Authority of Pakistan
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:
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