Regulatory/GMP Compliance, Emerging Markets

Regulatory Authorities have Published a Report on COVID Vaccine Development

July 16, 2020

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

Resources, Guidelines, and Guidance Documents

March 15, 2020

BioPharm International

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

Regulatory and Standard Setting Organizations

March 15, 2020

BioPharm International

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

Is There a “New Normal” for Drug Quality?

March 15, 2020

BioPharm International

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

Monograph Development: Why and When to Participate (eBook)

March 15, 2020

BioPharm International

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.

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

March 15, 2020

BioPharm International

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.

A Practical Approach to Pharmacopoeia Compliance (eBook)

March 15, 2020

BioPharm International

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

Revision Process for Global/National Pharmacopoeias

December 15, 2019

The revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world are described.

Revision Process for Global/National Pharmacopoeias (eBook)

December 15, 2019

BioPharm International

This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world.