Round-up, week 16 – 20 December 2019

Round-up, week 16-20 December 2019

By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud


Pharmtech series of articles on Pharmacopoeia Compliance

16 December 2019

Pharmtech has published a  series of articles on Pharmacopoeia Compliance.

The articles include:

  • Why Pharmacopoeia Compliance Is Necessary
  • Why Pharmacopoeia Compliance Is Difficult
  • A Brief History of Pharmacopoeias: A Global Perspective
  • Global Pharmacopoeia Standards: Why Harmonization is Needed
  • Harmonization Efforts by Pharmacopoeias and Regulatory Agencies

Additional informative articles on pharmacopoeial compliance will be added to the series in due course.


The FDA is mulling a pilot program to evaluate the toxicology and quality of novel excipients

17 December 2019

The FDA currently reviews novel excipients as part of investigational new drug applications or marketing applications. Review of excipients under this pilot program would obviate the need for separate FDA review of excipients in such contexts if their use is consistent with the recognized context of use, as listed in the FDA’s inactive ingredient database.

The agency is currently seeking comments from stakeholders to assist it in determining whether it should establish such a program. Comments can be submitted up till February 3rd, 2020.


GSK and AZ on continuous manufacturing platform ‘grand challenge’

18 December 2019

The Centre for Process Innovation is a British non-profit organisation connecting academia with the pharmaceutical industry. It funds projects to assist faster formulation development at lower cost.

A continuous direct compression (CDC) platform for the formulation of solid oral dosage (OSD) forms is under development at the University of Strathclyde.

The aim of the project, also known as ‘Grand Challenge 1’, is to increase the robustness and efficiency of the OSD formulation process, as opposed to the current system of batch processing. A CDC system will allow OSD medicines to be produced at a range of scales, thus, reducing optimization times allowing for more efficient use of starting materials.

The CDC platform is expected to be operational by end 2020 and will be established at the Medicines Manufacturing Innovation Centre in Renfrewshire, Scotland by 2021.



19 December 2019

A new draft monograph on balances has been published for consultation by the European Pharmacopoeia.

All weighings performed as part of tests to establish compliance with monographs within the pharmacopoeia need to be carried out according to the principles outlined in this chapter. Its scope is limited to balances used for analytical purposes, as the chapter does not cover those used for manufacturing or other purposes.

Stakeholders have until 31st March 2020 to submit related comments:


FDA Drafts Guidance on Demonstrating Substantial Evidence of Effectiveness

20 December 2019

The FDA has published the draft guidance ‘Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products’. The document complements current FDA guidance which was issued in support of statutory changes brought about by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

According to the FDAMA, approvals of new drugs and biologicals, and applications for supplemental indications, can be supported by a single adequate and well-controlled clinical trial and confirmatory evidence. Although this standard has not changed, the new guidance has been issued in light of new scientific advancements and the changes in drug development that have occurred since the original guidance was released.

The new guidance focuses particularly on drugs for rare diseases, for which “additional flexibility may be warranted” when demonstrating effectiveness. Different types of clinical trial design, the amount of evidence required to support approvals and several examples of approaches based on a single adequate and well-controlled clinical trial are also discussed in the document:

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