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

, September 2019
	September 2019
	Pages: 36–41

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

BioPharm International Regulatory Sourcebook

Articles

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.

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

, September 2019
September 2019
Pages: 26–34

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.

, September 2019
September 2019
Pages: 18–25

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)

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: 7–9

	When referring to this article, please cite it as 

 Editors, “What’s New in Regulations and Compliance," 

Features

Regulatory agencies and pharmacopeia organizations revised policies and guidelines in 2019. 

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, biopharma companies are encouraged to build a quality culture throughout the organization, starting with top executives at the company.

, September 2019
	September 2019
	Pages: 4–6

	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

Recent guidelines released by FDA emphasize the agency’s efforts to ease the path toward regulatory approval for biosimilars and marks significant action taken by the agency to help promote competition in the biologic market. The agency is working to implement a Biosimilars Action Plan that includes a suite of ongoing efforts to encourage innovation and competition among biologics and the development of biosimilars.

, September 2019
	September 2019
	Pages: 14–16

	When referring to this article, please cite it as F. Mirasol, “Biosimilar Quality Requirements," 

Pharmaceutical Technology Regulatory Sourcebook

This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosimilar development and characterization process.

Biosimilar Quality Requirements

The biopharmaceutical industry has undergone major changes since GMPs were last updated in 1977. However, FDA says it has no plans for any major revisions of cGMPs. Industry experts argue, however, that changes are needed in Training and employee personal development, statistics and sampling, and process validation.

, September 2019
	September 2019
	Pages: 10–13

	When referring to this article, please cite it as A. Shanley, “Is it Time to Update cGMPs?" 

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

Is it Time to Update cGMPs?

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

Regulatory Resources

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


Regulatory and Standard Setting Organizations

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

BioPharm International-09-15-2019