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

Pharmaceutical Technology’s March 2020 Regulatory Sourcebook

Articles

Resources

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

Resources, Guidelines, and Guidance Documents

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

Regulatory and Standard Setting Organizations

In February 2020, a report from FDA’s Office of Pharmaceutical Quality (OPQ) noted that, “Quite simply, the quality of our drug supply is better than ever before.” With some FDA inspections on hold, will the US drug supply maintain its quality standards? Plus, which new drug applications must now be filed as biologic license application?

	When referring to this article, please cite it as R. Peters, “A “New Normal” for Quality?" 

Pharmaceutical Technology Regulatory Sourcebook and Reference

Regulatory Update

With some FDA inspections on hold, will the US drug supply maintain its quality standards?

A ‘New Normal’ for Quality?

	This article explores another proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias.

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


	eBook: Regulatory Sourcebook, March 2020
	March 2020
	Pages: 14–23

	When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Monograph Development: Why and When to Participate," 

Pharmaceutical Technology Regulatory Sourcebook eBook

Pharmacopoeia Compliance Series

Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.

Monograph Development: Why and When to Participate (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.

	This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.


	eBook: Regulatory Sourcebook, March 2020
	March 2020
	Pages: 34–42

	When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon," 

This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.

Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon (eBook)

	A company initially discovers a new drug substance and develops it into a drug product, performing clinical studies to ensure it is safe and effective. During development, the company establishes standards of quality that are considered appropriate for the drug substance and product. When all the necessary drug development information is available, it is submitted to regulatory agencies to gain marketing approval for the product in countries around the world. During the regulatory review process, differences can emerge in the quality requirements that are approved for the product, based on determinations made by the health authorities in individual countries. These differences are often minor, but may also be quite significant, creating challenges for compliance in all countries where the product is approved.


	eBook: Regulatory Sourcebook, March 2020
	March 2020
	Pages: 24–32

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

This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.

A Practical Approach to Pharmacopoeia Compliance (eBook)

Since 2017, FDA has approved four gene therapies, and regulators expect the number of gene and cell therapies under development to increase dramatically.


	eBook: Regulatory Sourcebook, March 2020
	March 2020
	Pages: 6–9

	When referring to this article, please cite it as A. Shanley, “Inside FDA’s New Gene and Cell Therapy Guidances," 

Gene and Cell Therapies

In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.

Inside FDA’s New Gene and Cell Therapy Guidances

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.


	eBook: Regulatory Sourcebook, March 2020
	March 2020
	Pages: 10–13

	When referring to this article, please cite it as S. J. Schniepp, “ALCOA+ and Data Integrity," 

Data Integrity