FDA issued guidance documents that address patient-centric drug development, biosimilars, and a variety of biologics application guidelines. The US Pharmacopeial Convention (USP) also proposed some changes to monographs. A few notable actions taken this year are reviewed.

, September 2019
	September 2019
	Pages: 6–10

	When referring to this article, please cite it as Pharmaceutical Technology Editors, “What’s New in Regulations and Compliance," 

Pharmaceutical Technology Regulatory Sourcebook

Articles

Features

Regulatory agencies published guidelines to advance drug development, streamline submission processes, and promote biosimilars. 

What’s New in Regulations and Compliance

While patients generally trust that the drugs they take are safe, product recalls, drug shortages, reports of potential contaminants, and publicized regulatory enforcement actions can shake public confidence in the drug supply. While FDA looks to encourage voluntary compliance over the “stick” approach of tighter enforcement, bio/pharma companies are encouraged to build a quality culture throughout the organization, starting with top executives at the company.

, September 2019
	September 2019
	Pages: 4–5

	When referring to this article, please cite it as R. Peters, “Quality Culture Drives Patient Confidence in Drug Products," 

While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/pharma industry.

Quality Culture Drives Patient Confidence in Drug Products

Generic pharmaceuticals now account for more than 90% of all prescriptions issued in the United States. However, the generic pharmaceuticals’ pipeline flow is anything but smooth. A report issued on Aug. 7, 2019 by the US Government Accountability Office (GAO) (1) traces part of the problem to issues with FDA review. A New Prior Knowledge” concept that would make crucial process and product information available has been proposed by the National Institute for Pharmaceutical Technology and Education.

, September 2019
	September 2019
	Pages: 24–26

	When referring to this article, please cite it as A. Shanley, “Generics: Getting Beyond ‘File First, Figure it Out Later’," 

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues. 

Generics: Getting Beyond “File First, Figure it Out Later”

Validation of analytical procedures requires study of intermediate precision for within-laboratories variations; however, there is no global guidance on how to develop such designs. By applying science- and risk-based principles-aligned with quality by design (QbD)-to analytical procedures, studies can be designed to ensure the factors selected present the highest risk of impacting the performance of the analytical procedure. In addition, the number of independent analytical runs to include in these designs should be linked to the overall risk/complexity associated with the analytical procedure.

	Useful pre-QbD guidance (provided by the Japanese National Institute of Health Sciences) proposed the use of a generic design which utilizes six independent analytical runs. Examples are provided which instead link the design structure and the number of independent analytical runs to the risk.

, September 2019
	September 2019
	Pages: 12–22

	When referring to this article, please cite it as P.J. Borman, et al., “Risk-Based Intermediate Precision Studies for Analytical Procedure Validation," 

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies. 

Risk-Based Intermediate Precision Studies for Analytical Procedure Validation

Pharmacopoeias are embedded within the current regulatory and legal framework of the country or region in which they are applicable. The intersection of the pharmacopoeias and regulatory agencies impacts the direction and approaches taken to move toward harmonization at a global level.

	Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply, which ultimately benefits global patients who rely on these medicines to extend and improve their lives. This article provides some industry perspective on the need to harmonize compendial standards, which may be helpful in considering the future direction of pharmacopoeias.

	This article is part of a series that will be published in 2019–2020. 

, September 2019
	September 2019
	Pages: 43–47

	When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Global Pharmacopoeia Standards: Why Harmonization is Needed," 

Pharmacopoeial Compliance Series

In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.

Global Pharmacopoeia Standards: Why Harmonization is Needed (eBook)

For the bio/pharmaceutical industry, compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable.

	This article provides a comprehensive, end-to-end framework to help companies involved in the development, manufacture, and distribution of small-molecule drug products, biotherapeutic products, and vaccines-as well as the drug substances and excipients used in these products-to better understand the external and internal challenges that make pharmacopoeia compliance difficult.

, September 2019
	September 2019
	Pages: 36–42

	When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Why Pharmacopoeia Compliance Is Difficult," 

Why Pharmacopoeia Compliance Is Difficult (eBook)

Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable. Awareness and understanding of this need for pharmacopoeia Compliance is crucial.

	There is often insufficient understanding, however, by stakeholders at all levels of the need to comply with requirements in the pharmacopoeias. This situation can lead to a lack of appropriate attention and resources allocated to ensure compliance.

	This series of articles were written to provide a common understanding and to detail practical ways that pharmacopoeia compliance may be addressed.

	This article part of a series that will be published in 2019–2020. 

, September 2019
	September 2019
	Pages: 28–34

	When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Why Pharmacopoeia Compliance Is Necessary," 

Why Pharmacopoeia Compliance Is Necessary (eBook)

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Regulatory Resources

Resources, Guidelines, and Guidance Documents

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Pharmaceutical Technology-09-15-2019