Feature articles in October explored global regulatory strategy, including how to overcome the lack of standardization with Regulated Information Management (RIM), the best strategy for global submissions in this changing regulatory environment, trends changing the landscape of global regulatory submissions and the critically important oversight of regulatory professionals to ensure compliance of the product with legislation in the regions where the product is intended to be marketed to ensure safety of the public health. Other articles introduced strategies for the development of clinical summary documents, explained CFDA's new requirements for clinical trial applications and new drug applications, and summarized CFDA's recently released data integrity guidance document draft.
Global Regulatory Strategy
To maximize the Return on Investment (ROI) for a new drug, sponsors need marketing approval in as many jurisdictions in as short a time as possible. Once the major reference country approvals (US, EU) are obtained, a sponsor's chosen order of submissions in the Rest of the World (ROW) and how many of these are run in parallel (or how tightly they are sequenced) often determine future revenue.
In the article, "Global Regulatory Submissions: How to Build a Plan That Works Everywhere, Every Time," Bridges explains the best strategy for ROW submissions in this environment and explores two trends changing the landscape of global regulatory submissions.
Dean and Hardink discuss the growth of China's pharmaceutical market and provide the background of the global use and acceptance of the Common Technical Document (CTD). Their article, "China Food and Drug Administration Issues New Requirements for Clinical Trial Applications and New Drug Applications," goes on to outline the China Food and Drug Administration (CDFA) requirements for Clinical Trial Application (CTA) approval and New Drug Application (NDA) registration as critical steps in addressing drug quality, patient safety and shortening the time for access to new drugs in
The importance of developing a regulatory strategy is the focus of Menon's article, where she explains how companies can identify opportunities and problems prospectively. In her article, "Global Regulatory Strategy," she outlines how you can improve utilization of company resources and focus the development team on key objectives and assist in developing products with a positive benefit-risk profile that will show differential advantages and demonstrate value for prescribers and payers.
In the article, "The Evolving Role of the Regulatory Professional," Trivedi and Trivedi discuss the multifaceted role of regulatory professionals who must guide internal company functions from product formulation and analytical development, to manufacturing, supply chain, quality control, clinical and non-clinical science and statistics. The role includes understanding the changing regulatory environment, interpreting laws and regulations and generating relevant data to support compliance.
"Best Practices for Managing Regulatory Processes: Standardization" is the first in a series of articles covering Regulated Information Management (RIM). As industry leaders attested, system consolidation and automation will only succeed if data is standardized and processes are harmonized. Reilly explores RIM and reviews the most common standardization challenges, which are inconsistent data definition, data capture and processes.
Despite all of the public discussion about FDA's enforcement approach in the off-label promotional arena, the agency continues to take action against any perceived unlawful promotion. In their article, "FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective"
Minsk and Nduom present some recent FDA notice of violation letters to drug companies for promoting their investigational new drugs as safe and effective.
Other Feature Articles in October
New Draft CFDA Guidance Released
In the article, "Draft CFDA Guidance on Drug Data Management Practices," Liu and Schmitt summarize the China Food and Drug Administration's newly released draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This guidance is applicable to drug research and development, manufacturing, distribution and relevant activities, which include the organizations and individuals engaged in clinical trials, contract research organizations (CRO), contract manufacturing organizations (CMO) and contract testing.
Tabor provides an insightful review of "Eclectic Science and Regulatory Compliance: Stories for the Curious," which is a compilation of essays featuring new, somewhat obscure information about science, regulatory and healthcare products written by Max Sherman.
Education and Professional Development
In the article, "A Regulatory Experience of a Lifetime," Isikwe provides a personal account of a unique regulatory experience in the pharmaceutical industry, while interning for the Office of Prescription Drug Promotion (OPDP) and pursuing a doctorate of pharmacy degree.
Feature Articles to Look for in November
Quality and compliance is the theme for the November collection of feature articles with a discussion of quality metrics, including common misconceptions about quality control and quality assurance, what it means to measure quality and why it is important in our regulated industry. Other features will introduce recent trends in prescription drug promotion enforcement and explore the regulatory landscape of advertising and promotion. A summary of recent enforcement letters, an overview of changes in enforcement letter formatting and language and an analysis of trends in enforcement activity will be presented. Other articles will look at process validation and the importance of developing a sustainable regulatory-compliant Quality Management System (QMS). November also will highlight the second in the RIM series on best practices for managing automated regulatory processes.
Look for these feature articles and other hot topics throughout November.